{ "retrievedAt": "2026-10-30T01:36:40.097407+00:00", "asOf": "2026-10-29", "window": { "start": "2025-10-29", "end": "2026-10-29" }, "method": "Ten explicit public ClinicalTrials.gov v2 term searches, all returned pages, deduplicated by NCT ID. All-time discovery; first-posting and update fields retained for annual screening. Term matching is not compound or study verification. Not a global trials census. Registry data are sponsor-submitted; recruitment is not independently confirmed. No patient-level data or contact details retained.", "queries": [ { "term": "\"BPC-157\" OR \"BPC 157\"", "retrievedRecords": 4, "reportedTotal": 4, "pages": 1, "complete": true }, { "term": "\"TB-500\" OR \"TB500\"", "retrievedRecords": 1, "reportedTotal": 1, "pages": 1, "complete": true }, { "term": "\"MOTS-c\"", "retrievedRecords": 8, "reportedTotal": 8, "pages": 1, "complete": true }, { "term": "\"KPV\"", "retrievedRecords": 0, "reportedTotal": 0, "pages": 1, "complete": true }, { "term": "\"Semax\"", "retrievedRecords": 0, "reportedTotal": 0, "pages": 1, "complete": true }, { "term": "\"Epitalon\" OR \"Epithalon\"", "retrievedRecords": 1, "reportedTotal": 1, "pages": 1, "complete": true }, { "term": "\"CJC-1295\" OR \"CJC1295\"", "retrievedRecords": 1, "reportedTotal": 1, "pages": 1, "complete": true }, { "term": "\"Ipamorelin\"", "retrievedRecords": 3, "reportedTotal": 3, "pages": 1, "complete": true }, { "term": "\"Tesamorelin\"", "retrievedRecords": 24, "reportedTotal": 24, "pages": 1, "complete": true }, { "term": "\"GHK-Cu\" OR \"GHK Cu\"", "retrievedRecords": 3, "reportedTotal": 3, "pages": 1, "complete": true } ], "records": [ { "id": "NCT00123253", "title": "TH9507 in Patients With HIV-Associated Lipodystrophy", "officialTitle": "A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation", "protocolId": "TH9507/III/LIPO/010", "sponsor": "Theratechnologies", "status": "COMPLETED", "statusVerified": "2013-11", "firstPosted": "2005-07-22", "lastUpdatePosted": "2013-11-27", "start": { "date": "2005-06" }, "primaryCompletion": { "date": "2006-11", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE3" ], "enrollment": { "count": 412, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "DOUBLE" } }, "arms": [], "primaryOutcomes": [ { "measure": "Visceral adipose tissue (VAT)" } ], "resultsFirstPosted": null, "conditions": [ "HIV Infections", "Lipodystrophy" ], "interventions": [ { "type": "DRUG", "name": "TH9507" } ], "briefSummary": "HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00123253", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00123253" }, { "id": "NCT00257712", "title": "SMART: Somatotrophics, Memory, and Aging Research Trial", "officialTitle": "GHRH: Cognition in Aging and MCI", "protocolId": "28287-K", "sponsor": "University of Washington", "status": "COMPLETED", "statusVerified": "2013-12", "firstPosted": "2005-11-23", "lastUpdatePosted": "2013-12-19", "start": { "date": "2006-02" }, "primaryCompletion": { "date": "2011-12", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 151, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "DOUBLE", "whoMasked": [ "PARTICIPANT", "INVESTIGATOR" ] } }, "arms": [ { "label": "1", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: TH9507 human growth hormone releasing hormone (GHRH)" ] }, { "label": "2", "type": "PLACEBO_COMPARATOR", "interventionNames": [ "Drug: TH9507 human growth hormone releasing hormone (GHRH)" ] } ], "primaryOutcomes": [ { "measure": "Change in declarative memory, including total recall scores on three tests of memory and on dual task response time (RT), a test of executive function.", "timeFrame": "Baseline, 10, 20, and 30 weeks" } ], "resultsFirstPosted": null, "conditions": [ "Aging", "Mild Cognitive Impairment" ], "interventions": [ { "type": "DRUG", "name": "TH9507 human growth hormone releasing hormone (GHRH)" } ], "briefSummary": "The purpose of the SMART study was to better understand whether the body's own production of growth hormone (GH) would improve memory and problem solving ability, or cognitive function. The study was a double blind, placebo-controlled study of the cognitive effects of growth hormone releasing hormone (GHRH) in healthy older men and women and in those with mild cognitive impairment (MCI).", "detailedDescription": "There is considerable and compelling evidence from both the animal and human literature that the actions of the somatotrophic hormonal axis (growth hormone releasing hormone/growth hormone/insulin-like growth factor I) have significant and predictable effects on cognitive function (memory and reasoning ability). A preliminary study has recently shown that five months of growth hormone releasing hormone (GHRH) treatment improves cognitive function in healthy older men and women; there is also preliminary evidence that supports the likelihood of a similar effect in individuals diagnosed with MCI.\n\nThe study sample will include 160 adults, ages 55-90, half of whom will be cognitively healthy normal adults and half of whom will meet diagnostic criteria for Mild Cognitive Impairment (MCI). Each of these groups will contain equal numbers of men and women. The treatment with GHRH will be twenty weeks in duration. In light of the documented interactions between estrogens and GHRH/GH/IGF-I, each of the two study arms will contain equal proportions of women not on estrogen replacement therapy (NERT) and women on oral estrogen replacement therapy (ERT). ERT women will maintain a regular steady dosage of estrogens for at least seven days preceding each assessment\n\nCognitive assessments to evaluate treatment-related changes in memory and thinking abilities, as well as blood collection to evaluate several biomarkers of interest, will be performed at baseline, 10 and 20 weeks of treatment, and ten weeks post-treatment. In addition there will be five medication and symptom monitoring visits during the treatment period.\n\nThe study hypotheses are:\n\nH1: Healthy, cognitively normal older men and women treated with GHRH will show beneficial effects in cognitive function, including measures of memory, relative to placebo treated subjects.\n\nH2: MCI patients treated with GHRH will show beneficial effects in cognitive function, including measures of memory, relative to placebo treated MCI patients.\n\nH3: Changes in insulin-like-growth factor (IGF-I) will predict changes in cognition both for normal older adults and for MCI patients treated with GHRH.", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00257712", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00257712" }, { "id": "NCT00267527", "title": "A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity", "officialTitle": "A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks in HIV Infected Patients With HIV Associated Visceral Obesity", "protocolId": "GH100-013", "sponsor": "ConjuChem", "status": "TERMINATED", "statusVerified": "2006-10", "firstPosted": "2005-12-21", "lastUpdatePosted": "2006-10-16", "start": { "date": "2005-12" }, "primaryCompletion": null, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 120 }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "DOUBLE" } }, "arms": [], "primaryOutcomes": [], "resultsFirstPosted": null, "conditions": [ "Obesity", "HIV Infections" ], "interventions": [ { "type": "DRUG", "name": "CJC 1295" } ], "briefSummary": "This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo.\n\nThe objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"CJC-1295\" OR \"CJC1295\"" ], "url": "https://clinicaltrials.gov/study/NCT00267527", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00267527" }, { "id": "NCT00608023", "title": "TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy", "officialTitle": "A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation", "protocolId": "TH9507-CTR-1012", "sponsor": "Theratechnologies", "status": "COMPLETED", "statusVerified": "2022-09", "firstPosted": "2008-02-06", "lastUpdatePosted": "2022-09-30", "start": { "date": "2007-08" }, "primaryCompletion": { "date": "2008-10", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE3" ], "enrollment": { "count": 263, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin 12 months (T-T)", "type": "EXPERIMENTAL", "description": "Tesamorelin 2 mg/day for 12 months", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Tesamorelin-Placebo (T-P)", "type": "EXPERIMENTAL", "description": "Tesamorelin 2 mg/day for 6 months - Placebo for 6 months", "interventionNames": [ "Drug: Tesamorelin", "Drug: Placebo for Tesamorelin" ] }, { "label": "Placebo-Tesamorelin (P-T)", "type": "EXPERIMENTAL", "description": "Placebo 6 months - Tesamorelin 2 mg/day for 6 months", "interventionNames": [ "Drug: Tesamorelin", "Drug: Placebo for Tesamorelin" ] } ], "primaryOutcomes": [ { "measure": "Changes From Baseline in Fasting Blood Glucose at Week 52", "description": "Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.", "timeFrame": "Baseline and Week 52" }, { "measure": "Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52", "description": "Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.", "timeFrame": "Baseline and Week 52" } ], "resultsFirstPosted": { "date": "2014-01-15", "type": "ESTIMATED" }, "conditions": [ "Lipodystrophy", "HIV Infections" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Placebo for Tesamorelin" } ], "briefSummary": "Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation", "detailedDescription": "HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00608023", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00608023" }, { "id": "NCT00672074", "title": "Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus", "officialTitle": "A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients", "protocolId": "ST-IPAM-201", "sponsor": "Helsinn Therapeutics (U.S.), Inc", "status": "COMPLETED", "statusVerified": "2017-04", "firstPosted": "2008-05-06", "lastUpdatePosted": "2017-04-14", "start": { "date": "2008-04" }, "primaryCompletion": { "date": "2009-12", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 117, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "1 Ipamorelin", "type": "ACTIVE_COMPARATOR", "interventionNames": [ "Drug: Ipamorelin" ] }, { "label": "2 Placebo", "type": "PLACEBO_COMPARATOR", "interventionNames": [ "Drug: placebo" ] } ], "primaryOutcomes": [ { "measure": "Recovery of GI function", "timeFrame": "Until hospital discharge" } ], "resultsFirstPosted": null, "conditions": [ "Ileus" ], "interventions": [ { "type": "DRUG", "name": "Ipamorelin" }, { "type": "DRUG", "name": "placebo" } ], "briefSummary": "The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.", "detailedDescription": "The safety and efficacy of ipamorelin in the management of post-operative ileus", "hasResults": false, "matchedQueries": [ "\"Ipamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00672074", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00672074" }, { "id": "NCT00675506", "title": "Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese", "officialTitle": "Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity", "protocolId": "574", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2017-11", "firstPosted": "2008-05-09", "lastUpdatePosted": "2017-12-13", "start": { "date": "2008-07" }, "primaryCompletion": { "date": "2012-01", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 60, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "1", "type": "EXPERIMENTAL", "description": "Participants will receive treatment with growth hormone releasing hormone 1-44 (TH9507).", "interventionNames": [ "Drug: Growth hormone releasing hormone (GHRH) 1-44" ] }, { "label": "2", "type": "PLACEBO_COMPARATOR", "description": "Participants will receive treatment with placebo medication.", "interventionNames": [ "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "Change in Visceral Adipose Tissue Volume", "description": "Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.", "timeFrame": "Measured at baseline and Months 6 and 12" } ], "resultsFirstPosted": { "date": "2013-01-07", "type": "ESTIMATED" }, "conditions": [ "Abdominal Obesity", "Growth Hormone Deficiency" ], "interventions": [ { "type": "DRUG", "name": "Growth hormone releasing hormone (GHRH) 1-44" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "Obesity, a condition that occurs when a person has too much body fat, affects about 31% of people in the United States. It is associated with increased risk of diabetes, high blood pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is also associated with low levels of growth hormone, a hormone that affects rate of growth and the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that makes the body naturally increase its own growth hormone levels. Administering GHRH to people who are obese may help return their growth hormone levels to normal and, in turn, may lead to reduced abdominal fat and improved cardiovascular function. This study will evaluate the effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving cardiovascular function in people who are obese.", "detailedDescription": "Obesity, defined as having a high amount of excess body fat, is one of the most wide-spread health problems of today. A variety of factors can lead to obesity. These factors include physical inactivity, family history and genetics, metabolism, and hormone imbalance. The excess body fat in obesity increases a person's risk of a number of life-threatening diseases, including heart disease, gall stones, type 2 diabetes, and certain types of cancer. People with abdominal obesity, where fat is stored predominantly around a person's midsection, are particularly prone to weight-related diseases. Studies have shown that administration of growth hormone to obese people reduces abdominal fat, but can be associated with adverse side effects. GHRH is a natural hypothalamic peptide that stimulates growth hormone release. GHRH may be able to normalize growth hormone levels, reduce abdominal fat, and lessen risk for cardiovascular disease in people who are obese, without the associated side effects of growth hormone administration. However, further study is needed on GHRH. This study will evaluate the safety and effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving cardiovascular function in people who are obese.\n\nParticipation is this study will last 1 year from screening and will include 9 study visits. During Visit 1, participants will undergo screening tests that will include a medical history, a physical exam, body measurements, a blood draw, a urine test, a GHRH+Arginine stimulation test, an electrocardiogram (ECG), and a test for the presence of blood in stool. Eligible participants will return within the next 3 weeks for an inpatient clinic stay for Visit 2. Participants will be asked to keep a food record of all food consumed during the 4 days before the second visit. Visit 2 will include a physical exam, a medical and smoking history, a review of current medications, body measurements, an overnight blood draw, a body metabolism evaluation, an oral glucose tolerance test, and two questionnaires. Also during Visit 2, participants will be assigned randomly to treatment with active GHRH or placebo. Participants will then be taught how to give themselves injections of the study drug, which will be taken daily for 12 months. Participants will also receive a 1-month supply of study drug and will be supplied with refills in subsequent study visits. Upon starting treatment, participants will undergo more testing, including a whole body DEXA scan, abdominal computed tomography (CT) scan, carotid ultrasound, and ECG.\n\nVisit 3 will occur at Week 2 of treatment and will include a review of study medications, questions about any side effects experienced, vital sign measurements, a blood draw, an ECG, and, if female, a urine test. Visits 4, 5, and 7 will be identical to Visit 3 and will occur at Months 1, 3, and 9 respectively. Visit 6 will occur at Month 6 and will be identical to Visit 2 but without the overnight blood draw. Visit 8 will occur at Month 12 and will be identical to Visit 2, except no further study drug will be dispensed. At Month 13, participants will complete the final study visit, which will include repeat tests from Visit 1.", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00675506", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00675506" }, { "id": "NCT00795210", "title": "Effects of Short-term Growth Hormone in HIV-infected Patients", "officialTitle": "Effects of Short-term Growth Hormone in HIV-infected Patients", "protocolId": "DK63639A", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2013-10", "firstPosted": "2008-11-21", "lastUpdatePosted": "2014-01-08", "start": { "date": "2009-02" }, "primaryCompletion": { "date": "2012-11", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 25, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "GH 6mcg/kg/d", "type": "EXPERIMENTAL", "description": "Recombinant human growth hormone 6mcg/kg SC once daily", "interventionNames": [ "Drug: Growth hormone" ] }, { "label": "GH 2mg daily", "type": "EXPERIMENTAL", "description": "Recombinant human growth hormone 2mg SC once daily", "interventionNames": [ "Drug: Growth hormone" ] }, { "label": "Growth Hormone Releasing Hormone", "type": "EXPERIMENTAL", "description": "Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks", "interventionNames": [ "Drug: Growth Hormone Releasing Hormone" ] } ], "primaryOutcomes": [ { "measure": "Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug", "description": "Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.", "timeFrame": "after 2 weeks treatment" } ], "resultsFirstPosted": { "date": "2014-01-08", "type": "ESTIMATED" }, "conditions": [ "HIV Lipodystrophy" ], "interventions": [ { "type": "DRUG", "name": "Growth hormone" }, { "type": "DRUG", "name": "Growth Hormone Releasing Hormone" } ], "briefSummary": "The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.", "detailedDescription": "The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic \"low\" dose), or growth hormone 2mg/day (\"higher\" dose) for 2 weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period.", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00795210", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00795210" }, { "id": "NCT00850564", "title": "Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men", "officialTitle": "Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men", "protocolId": "DK63639B", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2011-04", "firstPosted": "2009-02-25", "lastUpdatePosted": "2011-04-19", "start": { "date": "2009-02" }, "primaryCompletion": { "date": "2010-04", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 15, "type": "ACTUAL" }, "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "Growth Hormone Releasing Hormone", "type": "EXPERIMENTAL", "description": "Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily", "interventionNames": [ "Drug: Growth Hormone Releasing Hormone (Tesamorelin)" ] } ], "primaryOutcomes": [ { "measure": "Mean Overnight Growth Hormone", "description": "Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.", "timeFrame": "at 2 weeks (i.e., after 2 weeks of treatment)" } ], "resultsFirstPosted": { "date": "2011-03-30", "type": "ESTIMATED" }, "conditions": [ "Healthy Volunteers" ], "interventions": [ { "type": "DRUG", "name": "Growth Hormone Releasing Hormone (Tesamorelin)" } ], "briefSummary": "The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.", "detailedDescription": "The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT00850564", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT00850564" }, { "id": "NCT01263717", "title": "Effects of Growth Hormone Releasing Hormone in HIV", "officialTitle": "Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy", "protocolId": "2007p-000638", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2017-09", "firstPosted": "2010-12-21", "lastUpdatePosted": "2017-10-30", "start": { "date": "2010-12" }, "primaryCompletion": { "date": "2014-02", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 54, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin", "type": "EXPERIMENTAL", "description": "Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose", "interventionNames": [ "Drug: tesamorelin" ] }, { "label": "Placebo (inactive injection)", "type": "PLACEBO_COMPARATOR", "description": "Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase", "interventionNames": [ "Drug: placebo" ] } ], "primaryOutcomes": [ { "measure": "Liver Fat", "description": "Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).", "timeFrame": "6 months" }, { "measure": "Visceral Adipose Tissue", "description": "Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.", "timeFrame": "6 months" } ], "resultsFirstPosted": { "date": "2014-10-13", "type": "ESTIMATED" }, "conditions": [ "HIV", "HIV Lipodystrophy" ], "interventions": [ { "type": "DRUG", "name": "tesamorelin" }, { "type": "DRUG", "name": "placebo" } ], "briefSummary": "HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness \\[cIMT\\]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.", "detailedDescription": "", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01263717", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01263717" }, { "id": "NCT01264497", "title": "Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes", "officialTitle": "A Double-blind, Randomized, Parallel, Placebo-controlled 12-week Evaluation of the Safety of Two Doses of TH9507 in Subjects With Stable, Type 2 Diabetes Mellitus", "protocolId": "TH9507/II/Diabetes/006", "sponsor": "Theratechnologies", "status": "COMPLETED", "statusVerified": "2010-12", "firstPosted": "2010-12-21", "lastUpdatePosted": "2010-12-21", "start": { "date": "2002-02" }, "primaryCompletion": { "date": "2002-11", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 55, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "DOUBLE", "whoMasked": [ "PARTICIPANT", "INVESTIGATOR" ] } }, "arms": [], "primaryOutcomes": [ { "measure": "Change from baseline in relative insulin response" } ], "resultsFirstPosted": null, "conditions": [ "Type 2 Diabetes" ], "interventions": [ { "type": "DRUG", "name": "TH9507" } ], "briefSummary": "The purpose of this study was to determine whether TH9507, a stabilized analogue of growth hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01264497", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01264497" }, { "id": "NCT01280344", "title": "Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function", "officialTitle": "Phase II Double-Blind Placebo-Controlled Dose Finding Study to Evaluate Safety/Efficacy of Ipamorelin Compared to Placebo for Recovery of Gastrointestinal Function in Patients Following Small or Large Bowel Resection w/Primary Anastomosis", "protocolId": "HT-IPAM-202", "sponsor": "Helsinn Therapeutics (U.S.), Inc", "status": "COMPLETED", "statusVerified": "2017-04", "firstPosted": "2011-01-20", "lastUpdatePosted": "2017-04-13", "start": { "date": "2011-04", "type": "ACTUAL" }, "primaryCompletion": { "date": "2013-06", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 320, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "0.03 mg/kg BID", "type": "EXPERIMENTAL", "description": "Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)", "interventionNames": [ "Drug: Ipamorelin" ] }, { "label": "0.06 mg/kg BID", "type": "EXPERIMENTAL", "description": "Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)", "interventionNames": [ "Drug: Ipamorelin" ] }, { "label": "0.06 mg/kg TID", "type": "EXPERIMENTAL", "description": "Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)", "interventionNames": [ "Drug: Ipamorelin" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "Matching placebo, TID (3 placebo infusions)", "interventionNames": [ "Drug: Saline Solution for Injection" ] } ], "primaryOutcomes": [ { "measure": "Recovery of Gastrointestinal (GI) Function", "description": "To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo", "timeFrame": "Up to 10 days" } ], "resultsFirstPosted": null, "conditions": [ "Gastrointestinal Dysmotility" ], "interventions": [ { "type": "DRUG", "name": "Saline Solution for Injection" }, { "type": "DRUG", "name": "Ipamorelin" } ], "briefSummary": "Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Ipamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01280344", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01280344" }, { "id": "NCT01388920", "title": "Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting", "officialTitle": "A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Doses of Tesamorelin in Stable Ambulatory COPD Subjects With Muscle Wasting", "protocolId": "TH9507-CTR-1025", "sponsor": "Theratechnologies", "status": "TERMINATED", "statusVerified": "2022-03", "firstPosted": "2011-07-07", "lastUpdatePosted": "2022-03-18", "start": { "date": "2011-09" }, "primaryCompletion": { "date": "2011-12", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 3, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin 2 mg", "type": "EXPERIMENTAL", "description": "Tesamorelin 2 mg/day", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Tesamorelin 3 mg", "type": "EXPERIMENTAL", "description": "Tesamorelin 3 mg/day", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "Placebo", "interventionNames": [ "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "Change From Baseline in Lean Body Mass at 6 Months", "description": "The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan", "timeFrame": "6 months" } ], "resultsFirstPosted": { "date": "2014-05-07", "type": "ESTIMATED" }, "conditions": [ "Chronic Obstructive Pulmonary Disease (COPD)" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life.\n\nMuscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance.\n\nThe primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.", "detailedDescription": "", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01388920", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01388920" }, { "id": "NCT01579695", "title": "Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®", "officialTitle": "A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®", "protocolId": "EMR200147-501", "sponsor": "Theratechnologies", "status": "TERMINATED", "statusVerified": "2018-09", "firstPosted": "2012-04-18", "lastUpdatePosted": "2018-09-11", "start": { "date": "2013-02", "type": "ACTUAL" }, "primaryCompletion": { "date": "2018-05", "type": "ACTUAL" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 391, "type": "ACTUAL" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "Exposed Group will receive Tesamorelin", "interventionNames": [ "Drug: Tesamorelin for injection" ] }, { "label": "Control Group will not receive Tesamorelin" } ], "primaryOutcomes": [ { "measure": "Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®", "timeFrame": "10 years" } ], "resultsFirstPosted": null, "conditions": [ "HIV" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin for injection" } ], "briefSummary": "The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01579695", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01579695" }, { "id": "NCT01591902", "title": "Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®", "officialTitle": "A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate Whether EGRIFTA® (Tesamorelin for Injection), 2 mg Once Daily SC, Increases the Risk of Development or Progression of Diabetic Retinopathy When Administered to HIV-infected Subjects With Abdominal Lipohypertrophy and Concomitant Diabetes", "protocolId": "EMR200147-500", "sponsor": "Theratechnologies", "status": "TERMINATED", "statusVerified": "2018-09", "firstPosted": "2012-05-04", "lastUpdatePosted": "2018-09-11", "start": { "date": "2012-06", "type": "ACTUAL" }, "primaryCompletion": { "date": "2018-05", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE4" ], "enrollment": { "count": 129, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "PREVENTION", "maskingInfo": { "masking": "DOUBLE", "whoMasked": [ "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "EGRIFTA Treatment Grop", "type": "EXPERIMENTAL", "description": "Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "Placebo-controlled", "interventionNames": [ "Drug: Placebo-Control" ] } ], "primaryOutcomes": [ { "measure": "Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale.", "description": "Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months", "timeFrame": "3 years" } ], "resultsFirstPosted": null, "conditions": [ "Diabetic Retinopathy", "HIV" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Placebo-Control" } ], "briefSummary": "To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).", "detailedDescription": "To date, EGRIFTA® has not been studied for longer than 1 year in human subjects, nor has EGRIFTA® been studied in Type 2 diabetic HIV-infected subjects who are receiving oral hypoglycemic agents, GLP-1 analogues, or insulin. The present study will assess the potential of EGRIFTA® to induce or exacerbate DR in HIV-infected subjects on antiretroviral therapy who have concomitant abdominal lipohypertrophy and T2DM, and explore the long-term effects of EGRIFTA® on glycemic control and major adverse cardiovascular event (MACE) in this population.", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01591902", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01591902" }, { "id": "NCT01632592", "title": "Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue", "officialTitle": "Abdominal Obesity, Cardiovascular Inflammation, and Effects of a Growth Hormone Releasing Hormone Analogue to Reduce Inflammation", "protocolId": "2012p-000917", "sponsor": "Massachusetts General Hospital", "status": "WITHDRAWN", "statusVerified": "2014-01", "firstPosted": "2012-07-03", "lastUpdatePosted": "2014-01-24", "start": { "date": "2014-01" }, "primaryCompletion": { "date": "2014-01", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 0, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "TRIPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] } }, "arms": [ { "label": "Growth Hormone Releasing Hormone", "type": "EXPERIMENTAL", "description": "Growth Hormone Releasing Hormone analogue, 2mg subcutaneously every day for 12 months.", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "interventionNames": [ "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "aortic \"target to background ratio\" (Aortic TBR)", "description": "aortic target-to-background ratio is a measure of the inflammation in the wall of the aorta that is made by positron emission tomography (PET) scanning in conjunction with computed tomography (CT) scanning.", "timeFrame": "12 months" } ], "resultsFirstPosted": null, "conditions": [ "Abdominal Obesity" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "Obesity is strongly associated with risk of cardiovascular disease (CVD). Data increasingly suggest that visceral adipose tissue (VAT) accumulation -- or increased abdominal fat -- is particularly deleterious to cardiovascular health, but further study is needed to test this idea. Increased abdominal fat may also be associated with lower secretion of a hormone called growth hormone (GH), which helps the body burn fat. The current study aims to carefully characterize relationships between abdominal fat and CVD. In addition, by using a medication called growth hormone releasing hormone, which is a strategy to reduce abdominal fat, the investigators will test the hypothesis that abdominal fat contributes uniquely to increased arterial inflammation.\n\nIn the first part of this study, the investigators will investigate both lean (healthy weight) individuals and individuals with increased abdominal fat. The investigators will study their body composition, cardiovascular risk measures, insulin sensitivity, and growth hormone dynamics, with the hypothesis that abdominal fat, independent of general obesity, will be strongly associated with arterial wall thickening and atherosclerotic inflammation. The investigators will assess arterial wall thickness, plaque morphology, and atherosclerotic inflammation, and the investigators will determine associations between these variables and regional fat accumulation, with particular attention to abdominal fat.\n\nThe second, treatment part of the study will be only for individuals with increased abdominal fat who are found to have low growth hormone secretion. In that part of the study, the investigators will test the effects of a growth hormone releasing hormone (GHRH) analogue to reduce abdominal fat and, consequently, reduce arterial inflammation. The investigators hypothesize that abdominal fat reduction, independent of changes in growth hormone, will reduce arterial inflammation and arterial wall thickness.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01632592", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01632592" }, { "id": "NCT01788462", "title": "Egrifta Replacement and Sleep Disordered Breathing", "officialTitle": "Egrifta Replacement and Sleep Disordered Breathing", "protocolId": "NA_00074675", "sponsor": "Johns Hopkins University", "status": "WITHDRAWN", "statusVerified": "2017-03", "firstPosted": "2013-02-11", "lastUpdatePosted": "2017-03-03", "start": { "date": "2012-05" }, "primaryCompletion": { "date": "2020-01", "type": "ESTIMATED" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 0, "type": "ACTUAL" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "HIV and Lipodystrophy", "description": "The study population will consist of HIV patients with lipodystrophy who receive Tesamorelin (Egrifta).", "interventionNames": [ "Drug: Tesamorelin (Egrifta)" ] } ], "primaryOutcomes": [ { "measure": "Changes in Sleep Apnea Severity", "description": "Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.", "timeFrame": "Subjects will be evaluated prior to initiating tesamorelin therapy (baseline)" }, { "measure": "Changes in Sleep Apnea Severity", "description": "Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.", "timeFrame": "Subjects will be evaluated at three months" }, { "measure": "Changes in Sleep Apnea Severity", "description": "Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.", "timeFrame": "Subjects will be evaluated at six months" }, { "measure": "Changes in Sleep Apnea Severity", "description": "Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.", "timeFrame": "Subjects will be evaluated at one year" } ], "resultsFirstPosted": null, "conditions": [ "Lipodystrophy" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin (Egrifta)" } ], "briefSummary": "Sleep-disordered breathing is characterized primarily by partial or total upper airway obstruction during sleep. The most common form of sleep-disordered breathing is obstructive sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep state. The major risk factors associated with the development of sleep apnea are obesity and male sex. The investigators have also found a high prevalence of OSA in HIV infected men and women, particularly among those with central lipohypertrophy, which is a common finding in HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters both mechanical properties and compensatory neuromuscular responses leading to upper airway obstruction. Based on our most recent findings in the non-HIV population, the investigators demonstrate that obesity is associated with elevations in the upper airway load (passive Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the investigators have found that female sex, peripheral adiposity, and younger age are associated with increased compensatory neuromuscular responses, while male sex, central adiposity, and older age are associated with blunted compensatory responses. The loss of the compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The investigators hypothesize that tesamorelin therapy will reverse both the mechanical and neurocompensatory alterations associated with increased central obesity. In this project the investigators will determine whether tesamorelin affects sleep apnea severity and compensatory neuromuscular responses of the upper airway on sleep and breathing in men and women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic basis for the development of obstructive sleep apnea in this population. The studies also provide insights into the neurohumoral regulation of upper airway function, and potentially new approaches to the treatment for sleep-disordered breathing.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT01788462", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01788462" }, { "id": "NCT02012556", "title": "Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients", "officialTitle": "A Phase 1 Study to Evaluate the Pharmacokinetics and the Pharmacodynamics of TH9507 Administered Subcutaneously Once Daily for 14 Consecutive Days in HIV Positive Patients", "protocolId": "TH9507-CTR-1015", "sponsor": "Theratechnologies", "status": "COMPLETED", "statusVerified": "2013-12", "firstPosted": "2013-12-16", "lastUpdatePosted": "2013-12-16", "start": { "date": "2008-05" }, "primaryCompletion": { "date": "2008-07", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1" ], "enrollment": { "count": 18, "type": "ACTUAL" }, "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "Tesamorelin", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: Tesamorelin" ] } ], "primaryOutcomes": [ { "measure": "Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.", "timeFrame": "Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14." }, { "measure": "Peak Plasma Concentration (Cmax) of Tesamorelin.", "timeFrame": "Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14." }, { "measure": "Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.", "timeFrame": "Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14." }, { "measure": "Apparent Elimination Half-life (T1/2 el) of Tesamorelin.", "timeFrame": "Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14." }, { "measure": "Plasma Clearance (CI/F) of Tesamorelin.", "timeFrame": "Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14." }, { "measure": "Apparent Volume of Distribution (Vd/F) of Tesamorelin.", "timeFrame": "Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14." }, { "measure": "Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.", "timeFrame": "Day 1." }, { "measure": "Insulin-like Growth Factor-1 (IGF-1) Level at Day 7", "timeFrame": "Day 7." }, { "measure": "Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.", "timeFrame": "Day 13." }, { "measure": "Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.", "timeFrame": "Day 14." } ], "resultsFirstPosted": null, "conditions": [ "HIV" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" } ], "briefSummary": "The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT02012556", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT02012556" }, { "id": "NCT02196831", "title": "Tesamorelin Effects on Liver Fat and Histology in HIV", "officialTitle": "Tesamorelin Effects on Liver Fat and Histology in HIV: A Collaborative UO1 Grant", "protocolId": "1U01AI115711", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2020-01", "firstPosted": "2014-07-22", "lastUpdatePosted": "2020-01-27", "start": { "date": "2015-07-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2019-01-16", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 61, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin", "type": "EXPERIMENTAL", "description": "tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.", "interventionNames": [ "Drug: tesamorelin" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.", "interventionNames": [ "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy", "description": "change (value at 12 months minus value at baseline). Hepatic fat fraction is a standardized measure used to describe the percent fat in the liver. As it is determined by spectroscopy, it is quantified by the area under the lipid peak, standardized to the total area under the (lipid peak + water peak). Using 1-H Magnetic resonance spectroscopy to quantify liver fat in this manner was first described by Longo R et al., Invest Radiol, 1993, 28(4):297-302.", "timeFrame": "change between baseline and 12 months" } ], "resultsFirstPosted": { "date": "2020-01-13", "type": "ACTUAL" }, "conditions": [ "Human Immunodeficiency Virus (HIV)", "Nonalcoholic Fatty Liver Disease (NAFLD)", "Nonalcoholic Steatohepatitis (NASH)" ], "interventions": [ { "type": "DRUG", "name": "tesamorelin" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis.\n\nNAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.", "detailedDescription": "", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT02196831", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT02196831" }, { "id": "NCT02553603", "title": "The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment", "officialTitle": "The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment", "protocolId": "15-0086", "sponsor": "The University of Texas Medical Branch, Galveston", "status": "COMPLETED", "statusVerified": "2019-10", "firstPosted": "2015-09-17", "lastUpdatePosted": "2019-11-04", "start": { "date": "2017-07-18", "type": "ACTUAL" }, "primaryCompletion": { "date": "2019-01-17", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1" ], "enrollment": { "count": 22, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "TRIPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] } }, "arms": [ { "label": "Mild Cognitive Impairment, Placebo", "type": "PLACEBO_COMPARATOR", "description": "Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).", "interventionNames": [ "Drug: Placebo Growth Hormone Releasing Hormone" ] }, { "label": "Non-cognitively impaired, Placebo", "type": "PLACEBO_COMPARATOR", "description": "Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).", "interventionNames": [ "Drug: Placebo Growth Hormone Releasing Hormone" ] }, { "label": "Mild Cognitive Impairment, GHRH", "type": "EXPERIMENTAL", "description": "Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).", "interventionNames": [ "Drug: Growth Hormone Releasing Hormone (GHRH)" ] }, { "label": "Non-cognitively impaired, GHRH", "type": "EXPERIMENTAL", "description": "Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).", "interventionNames": [ "Drug: Growth Hormone Releasing Hormone (GHRH)" ] } ], "primaryOutcomes": [ { "measure": "Cognitive Function measured by SLUMS", "description": "Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)", "timeFrame": "10 weeks" }, { "measure": "Brain Perfusion measured by fMRI", "description": "Brain Perfusion at 10 week measured by MRI", "timeFrame": "10 weeks" }, { "measure": "Brain Morphology measured by MRI", "description": "Brain Morphology at 10 weeks measured by MRI", "timeFrame": "10 weeks" } ], "resultsFirstPosted": null, "conditions": [ "Mild Cognitive Impairment" ], "interventions": [ { "type": "DRUG", "name": "Growth Hormone Releasing Hormone (GHRH)" }, { "type": "DRUG", "name": "Placebo Growth Hormone Releasing Hormone" } ], "briefSummary": "This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.", "detailedDescription": "Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks.\n\nThis study is designed to investigate the effects of GHRH on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4) physical function as measured by a walking test.", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT02553603", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT02553603" }, { "id": "NCT02572323", "title": "Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons", "officialTitle": "Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons", "protocolId": "R01AG048650", "sponsor": "University of California, San Diego", "status": "COMPLETED", "statusVerified": "2026-02", "firstPosted": "2015-10-08", "lastUpdatePosted": "2026-03-12", "start": { "date": "2017-02-15", "type": "ACTUAL" }, "primaryCompletion": { "date": "2023-10-15", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 73, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": "Participants are randomly assigned to the immediate or deferred group. Participants in the Immediate group receive tesamorelin for 6 months and then no drug for 6 months. Participants in the Deferred group receive no drug for 6 months and then tesamorelin for 6 months.", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "SINGLE", "whoMasked": [ "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Immediate group", "type": "ACTIVE_COMPARATOR", "description": "1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Deferred group", "type": "PLACEBO_COMPARATOR", "description": "No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months", "interventionNames": [ "Drug: Tesamorelin" ] } ], "primaryOutcomes": [ { "measure": "Change in Neurocognitive Performance", "description": "The primary outcome was neurocognitive (NC) change, measured by the summary regression-based change score (sRCS), derived from a comprehensive battery assessing seven NC domains using the Global Deficit Score (GDS). The sRCS is calculated as a z-score from regression model residuals between baseline and week 24, adjusting for practice effects, statistical artifacts, and demographics. Altogether, 15 individual z scores are computed, by dividing the difference between predicted (Xp) and obtained (Xo) follow-up scaled scores by the error term of the regression model (Xo-Xp/SD-residual) and then averaged to generate the sRCS. Scores center around 0 (no change), with negative scores indicating decline and positive scores improvement. Significant changes are defined by 90% confidence intervals (±1.645 SD) such that participants in the top 5% of the sRCS distribution of the normative, stable reference sample were defined as \"improved,\" and the bottom 5% were defined the \"decliners.\"", "timeFrame": "Baseline and week 24" } ], "resultsFirstPosted": { "date": "2026-03-12", "type": "ACTUAL" }, "conditions": [ "Mild Cognitive Impairment" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" } ], "briefSummary": "The aim of this study is to test whether tesamorelin, in combination with a text-messaging application to help with motivation and adherence, will significantly improve memory and thinking in HIV.", "detailedDescription": "HIV infection can result in memory and thinking difficulties in some people, even those successfully treated with antiretroviral medications. Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV. Abdominal fat accumulation is linked to memory and thinking difficulties, and previous studies have suggested that tesamorelin also may be beneficial for memory and thinking, but this has not been tested in HIV. The aim of this study is to test whether tesamorelin, in combination with a text-messaging application to help with motivation and adherence, will significantly improve memory and thinking in HIV. We plan to enroll 100 volunteers with HIV infection at 2 sites - the University of California, San Diego and the University of Southern California, University of San Francisco and the satellite site, PalmTree Clinical Research, Inc. Before entry, volunteers will be required to show evidence of abdominal obesity and a minimum level of memory and thinking difficulties on cognitive tests. This is a randomized trial in which each volunteer will have a 60% chance of initially receiving tesamorelin (the immediate group) and a 40% chance of initially receiving no treatment (the deferred group). Subsequently, the deferred group (those who initially received no treatment) will receive tesamorelin for 6 months and those who initially received tesamorelin will receive no treatment for 6 months. Volunteers will be trained in the use of a 2-way text-messaging system that will help the research team to support volunteers' ability to take the study medication as directed. We will measure volunteers' memory and thinking skills before and at the end of treatment. We will collect blood at various points during the study to check for safety of the treatment and to determine its effects on the body. Volunteers will also be asked to have magnetic resonance scans of the head and abdomen to monitor the effects of the study medication on brain chemistry and abdominal fat.", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT02572323", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT02572323" }, { "id": "NCT02637284", "title": "PCO-02 - Safety and Pharmacokinetics Trial", "officialTitle": "Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157, a Penta-deca-peptide From Gastric Source.", "protocolId": "SPK-1A/B-1.3", "sponsor": "PharmaCotherapia d.o.o.", "status": "UNKNOWN", "statusVerified": "2015-10", "firstPosted": "2015-12-22", "lastUpdatePosted": "2015-12-22", "start": { "date": "2015-10" }, "primaryCompletion": { "date": "2016-02", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1" ], "enrollment": { "count": 42, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "BASIC_SCIENCE", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Intervention 1a (cohort 1)", "type": "EXPERIMENTAL", "description": "Single dose of 1 oral tablet of PCO-02 containing 1 mg of Bepecin (12 subjects)", "interventionNames": [ "Drug: Bepecin" ] }, { "label": "Intervention 1a (cohort 2)", "type": "EXPERIMENTAL", "description": "Single dose of 3 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)", "interventionNames": [ "Drug: Bepecin" ] }, { "label": "Intervention 1a (cohort 3)", "type": "EXPERIMENTAL", "description": "Single dose of 6 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)", "interventionNames": [ "Drug: Bepecin" ] }, { "label": "Control group 1a (cohort 1)", "type": "PLACEBO_COMPARATOR", "description": "Single dose of 1 oral tablet of PCO-03 as placebo (2 subjects)", "interventionNames": [ "Drug: Placebo" ] }, { "label": "Control group 1a (cohort 2)", "type": "PLACEBO_COMPARATOR", "description": "Single dose of 3 oral tablets of PCO-03 as placebo (2 subjects)", "interventionNames": [ "Drug: Placebo" ] }, { "label": "Control group 1 a (cohort 3)", "type": "PLACEBO_COMPARATOR", "description": "Single dose of 6 oral tablets of PCO-03 as placebo by mouth (2 subjects)", "interventionNames": [ "Drug: Placebo" ] }, { "label": "Intervention 1b", "type": "EXPERIMENTAL", "description": "Multiple dose regime of 3 oral tablets of PCO-02 containing 1 mg Bepecin every 8 hours during 2 weeks (36 subjects)", "interventionNames": [ "Drug: Bepecin" ] }, { "label": "Control group 1b", "type": "PLACEBO_COMPARATOR", "description": "Multiple dose regime of 3 oral tablets of PCO-03 as placebo every 8 hours during 2 weeks (6 subjects)", "interventionNames": [ "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "Adverse events", "description": "Any adverse event reported during the study.", "timeFrame": "Six months" } ], "resultsFirstPosted": null, "conditions": [ "Healthy Volunteers" ], "interventions": [ { "type": "DRUG", "name": "Bepecin" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.", "detailedDescription": "Title: Phase I, pilot study in healthy volunteers, to assess the safety and pharmacokinetics of PCO-02, which active ingredient is BPC-157, a pentadecapeptide from gastric source.\n\nProtocol Number: BPC-1A/B-1.2\n\nPhase: I\n\nPopulation: Healthy subjects, males or females, between 18 and 35 years of age.\n\nNumber of Sites: Single center, to be performed at Hospital Angeles, Tijuana.\n\nDuration of Study: Six months, from January 01, 2015 to Jun 30, 2015.\n\nDuration of Subject Participation: Three weeks\n\nIntervention description:The study consists of the oral administration of PCO-02 tablets, each containing 1mg of BPC-157 or placebo. There will be two different administration schemes, which have been labeled as Phase 1a and Phase 1b.\n\n* Phase 1a: Single dose administration of 1, 3 or 6 tablets of PCO-02 or placebo.\n* Phase 1b: Oral administration of 3 tablets of PCO-02 or placebo three times daily for 2 weeks.\n\nStudy Goals:General: To assess, in healthy volunteers, the safety and pharmacokinetics of the oral administration of PCO-02, which pharmacological active product is BPC-157.\n\n* Primary: To assess the safety of the oral administration of BPC-157.\n* Secondary: To document the pharmacokinetics of BPC-157 after oral administration.\n\nStudy Design: This is a phase-I, randomized, placebo controlled, pilot study, in which a group of 42 healthy volunteers will receive orally an active compound (PCO-02) or placebo (PCO-03) to assess safety and pharmacokinetics.\n\nPhase 1a: There will be three cohort groups, with 14 subjects each, that will receive a single oral dose of 1, 3 or 6 tablets of PCO-02, respectively or a similar dose of placebo (PCO-03). Randomization will be at a PCO-02-to-placebo ratio of 6:1 on each group, keeping a balance between men and women among groups.\n\nFor this phase, subjects will be admitted to the hospital for 24 hours and will be kept fasting before and after the administration of the study medication. Serial blood and urine samples will be obtained to document pharmacokinetics of BPC-157 peptide and the subjects from all groups will be observed for AE in order to determine the study medication's safety. A week after, subjects will return for clinical assessment and laboratory blood work to continue monitoring for AE's.\n\nAlso, the cohort that will receive 3 tablets will receive a second dose in a similar manner but after having had a meal.\n\nPhase 1b:This second phase will initiate only once all subjects from prior phase have completed at least one week of follow-up and that there have been no SAE's related to study medication from phase 1a.\n\nAll of subjects from phase 1a will receive a single dose of 3 tablets of PCO-02 or placebo three times daily for a period of 14 days. The assignment to active (PCO-02) or placebo (PCO-02) will be the same as per the randomization for phase 1a.\n\nThis phase will be performed on an ambulatory manner, with the subjects being required to return to the clinic at days 0, 7 and 14 for safety and pharmacokinetics assessment.\n\nEstimated Time to Complete Enrollment: One month\n\nStudy Goals:\n\nPrimary: Safety of oral administration of PCO-02, evaluated thru the systematic monitoring for adverse events during follow-up.\n\nSecondary: Pharmacokinetics of oral BCP-157 (Tmax, Cmax, T1/2, AUC)\n\nClinical Assessment During Follow- Up: During phase 1a, subjects will be admitted to the hospital for 24 hours for monitoring adverse events and serial blood and urine sampling after a single dose of PCO-02 or placebo (PCO-03). Subjects will be discharged from the hospital on the next morning and will return a week after the initial dose for clinical assessment and laboratory blood work to continue monitoring for possible AE's. The first cohort will receive 1 tablet of PCO-02 or placebo. Increasing to the next dose requires the absence of severe adverse events related to the intervention in the previous dose cohort at one week of follow-up.\n\nIf there has been no AE's related to study medication, phase 1b will be started. Initial assessment of phase 1b will be the same as the final evaluation of phase 1a. All the subjects from phase 1a will receive a single dose of 3 tablets of PCO-02 three times daily, or a similar dose of placebo (PCO-03), for a period of 2 weeks. The assignment to active compound or placebo will be the same as for phase 1a.\n\nThe subject will be required to return to the clinic at days 7 and 14 for clinical, pharmacokinetics and safety assessment, including blood and urine sampling.", "hasResults": false, "matchedQueries": [ "\"BPC-157\" OR \"BPC 157\"" ], "url": "https://clinicaltrials.gov/study/NCT02637284", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT02637284" }, { "id": "NCT02931474", "title": "Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia", "officialTitle": "The Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia", "protocolId": "170005", "sponsor": "National Institute of Nursing Research (NINR)", "status": "WITHDRAWN", "statusVerified": "2017-03-08", "firstPosted": "2016-10-13", "lastUpdatePosted": "2019-11-19", "start": { "date": "2016-10-06" }, "primaryCompletion": { "date": "2017-03-08", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 0, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "TRIPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] } }, "arms": [ { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "Salt Water Solution", "interventionNames": [ "Other: Placebo" ] }, { "label": "Tesamorelin", "type": "EXPERIMENTAL", "description": "Growth Hormone-Releasing", "interventionNames": [ "Drug: Tesamorelin" ] } ], "primaryOutcomes": [ { "measure": "Change in NREM time following tesamorelin administration compared to placebo", "timeFrame": "1-3 weeks" } ], "resultsFirstPosted": null, "conditions": [ "Sleep Disorder", "Traumatic Brain Injury" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "OTHER", "name": "Placebo" } ], "briefSummary": "Background:\n\nPeople who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI.\n\nObjective:\n\nTo see if GHRH can improve sleep in people who have had a TBI.\n\nEligibility:\n\nActive duty service members or veterans (active duty in the past 10 years) ages 18-45 who have had a TBI in the past 6 months to 10 years.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nGetting ACTH (a hormone) through an intravenous catheter (thin plastic tube)\n\nInterview about their mood and alcohol and drug use\n\nQuestionnaires about their TBI, mood, and sleep\n\nParticipants will have 2 overnight study visits a couple weeks apart. These will include:\n\nPhysical exam\n\nUrine sample\n\nTwo intravenous catheters placed. Blood samples will be taken throughout the night.\n\nTwo shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the other.\n\nSpending the night in the sleep lab. Their brain waves will be recorded with electrodes placed on the scalp.\n\nA questionnaire in the morning about their sleep\n\nParticipants will be called a few days after each overnight visit. They will be asked about how they are feeling and to rate their sleep.", "detailedDescription": "Objective: Traumatic brain injury (TBI) is the hallmark injury of deployment in Iraq and Afghanistan. Up to one-third of service members who sustain a TBI are diagnosed with a sleep disorder; insomnia being one of the most common. Currently, over half of TBI-associated insomnia cases remain untreated due to poor efficacy of available pharmacologic agents. Neuroendocrine dysfunction is an important mechanism linking TBI and disordered sleep, thus pharmacological agents that address this dysfunction may be effective in treating TBI-related insomnia. The neuroendocrine system is essential for regulating sleep and circadian function. Decreased neuroendocrine function, including the hypothalamus and the somatotrophic cells of the anterior pituitary, which regulate growth hormone secretion, likely contributes to insomnia. This assertion is supported by previous studies that demonstrated the sleep-promoting effects of growth hormone releasing hormone (GHRH) administration in healthy controls, the elderly, and participants with depression. Therefore, we propose that administration of GHRH will address the underlying mechanisms of insomnia in service members and veterans who sustained a TBI, and provide a pharmacological agent more robust than currently available treatments.\n\nStudy population: This study will recruit 50 active duty service members and veterans with a documented TBI to participate in one of two study groups. The insomnia group (n=25) will include participants that have a current clinical diagnosis of insomnia without obstructive sleep apnea. The no-insomnia group (n=25) will include participants with no current clinical diagnosis of insomnia or obstructive sleep apnea. Withdrawals/dropouts will be replaced to obtain 20 participants per group who complete the study.\n\nDesign: A double-blind, randomized, crossover design will be used to examine the impact of tesamorelin (GHRH (1-44) analog) or placebo on total non-rapid eye movement (NREM) time evaluated during two polysomnography visits, scheduled 1-3 weeks apart. Serial blood draws will be obtained during the polysomnography to examine endocrine function and neuropeptide release.\n\nOutcome measures: The primary outcome is change in NREM time following tesamorelin administration compared to placebo. The secondary outcomes are (1) within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo and (2) within and between group differences in urinary concentration levels of growth hormone following tesamorelin administration compared to placebo.", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT02931474", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT02931474" }, { "id": "NCT03150511", "title": "Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury", "officialTitle": "Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury", "protocolId": "IRB00110936-2", "sponsor": "Johns Hopkins University", "status": "RECRUITING", "statusVerified": "2025-11", "firstPosted": "2017-05-12", "lastUpdatePosted": "2025-11-12", "start": { "date": "2018-06-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2027-12", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 36, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin treatment", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: Tesamorelin 2 Milligrams (MG)" ] }, { "label": "No Drug", "type": "NO_INTERVENTION" } ], "primaryOutcomes": [ { "measure": "3-point chuck pinch test", "description": "Pinch strength measure as measured by a pinch gauge.", "timeFrame": "12 months" } ], "resultsFirstPosted": null, "conditions": [ "Peripheral Nerve Injuries" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin 2 Milligrams (MG)" } ], "briefSummary": "The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will result in faster and more substantial recovery of motor and sensory function following surgical repair of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly assigned to receive either tesamorelin treatment or no treatment. Assessments for nerve regeneration, muscle function, and sensation will be conducted every three months for a total of 12 months. Outcomes in patients receiving tesamorelin will be compared to those in the untreated group to determine the effectiveness of tesamorelin as a therapeutic intervention for nerve injuries.", "detailedDescription": "This is a randomized, double-blinded, clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. Tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies.\n\nA total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive no treatment. To minimize bias, outcome assessors and the biostatistician analyzing the data will be blinded to the treatment assignments. Following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. Outcome assessments will include clinical exams, electrodiagnostic studies and questionnaires.\n\nThe total duration of the study is expected to be 4 years.", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT03150511", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03150511" }, { "id": "NCT03226821", "title": "Body Composition and Adipose Tissue in HIV", "officialTitle": "Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy", "protocolId": "AAAR2634", "sponsor": "Columbia University", "status": "TERMINATED", "statusVerified": "2026-04", "firstPosted": "2017-07-24", "lastUpdatePosted": "2026-05-19", "start": { "date": "2018-02-07", "type": "ACTUAL" }, "primaryCompletion": { "date": "2025-04-30", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE4" ], "enrollment": { "count": 6, "type": "ACTUAL" }, "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "Tesamorelin", "type": "EXPERIMENTAL", "description": "Subjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit.", "interventionNames": [ "Drug: Tesamorelin" ] } ], "primaryOutcomes": [ { "measure": "Hepatic Lipid Content", "description": "Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).", "timeFrame": "Baseline" } ], "resultsFirstPosted": { "date": "2026-05-19", "type": "ACTUAL" }, "conditions": [ "HIV Lipodystrophy Syndrome", "Growth Hormone Deficiency", "Body Composition" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" } ], "briefSummary": "In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.", "detailedDescription": "HIV lipodystrophy is increasingly recognized as a common and clinically significant long-term sequelae of HIV treatment. In the HIV lipodystrophy lipohypertrophy phenotype, visceral adipose tissue (VAT) is increased and this is associated with reduced growth hormone (GH) secretion. Mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (CV) disease in patients with HIV disease. The etiology of HIV lipodystrophy (HIVLD) with central adiposity is unclear, but this phenotype is increasingly common with newer, less lipotoxic combination anti-retroviral therapy (cART) use. VAT and hepatic lipid accumulation, are important health concerns for HIVLD patients. This body composition pattern may contribute to the increased cardiovascular risk that has been demonstrated in patients with HIV lipodystrophy. Patients with HIVLD and central adiposity have been shown to have reduced GH secretion. Thus, a medication has been developed to augment GH secretion. This medication is tesamorelin. GH supplementation in other clinical settings has been shown to reduce visceral adiposity and may reduce hepatic lipid content.", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT03226821", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03226821" }, { "id": "NCT03375788", "title": "Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk", "officialTitle": "Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk", "protocolId": "R01DK114144", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2025-11", "firstPosted": "2017-12-18", "lastUpdatePosted": "2025-11-20", "start": { "date": "2019-01-17", "type": "ACTUAL" }, "primaryCompletion": { "date": "2024-07-10", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 51, "type": "ACTUAL" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Randomized, double-blind, placebo controlled phase for first 12 months, followed by open-label phase for 6 months during which all participants receive active medication (tesamorelin)", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin", "type": "EXPERIMENTAL", "description": "tesamorelin (brand name Egrifta) 2mg daily given subcutaneously", "interventionNames": [ "Drug: Tesamorelin" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "identical placebo given subcutaneously daily", "interventionNames": [ "Drug: Identical Placebo" ] } ], "primaryOutcomes": [ { "measure": "Liver Fat Content", "description": "Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy. All available data used; data not available for 1 participant in tesamorelin group and 3 participants in placebo group.", "timeFrame": "change from baseline to 12 months" } ], "resultsFirstPosted": { "date": "2025-11-20", "type": "ACTUAL" }, "conditions": [ "Non-Alcoholic Fatty Liver Disease", "Obesity", "Obesity, Abdominal", "Liver Fat", "Fatty Liver" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Identical Placebo" } ], "briefSummary": "Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than individuals without obesity. There are data to suggest that growth hormone may help to reduce the amount of fat in the liver, and may also reduce inflammation in the liver, both of which would be helpful to individuals with NAFLD. The purpose of this study is to investigate whether treatment with a drug called tesamorelin, which is a growth hormone releasing hormone analogue, will decrease liver fat and improve liver inflammation and scarring in obese individuals with NAFLD.", "detailedDescription": "", "hasResults": true, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT03375788", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03375788" }, { "id": "NCT03826160", "title": "Growth Hormone Dynamics and Cardiac Steatosis in HIV", "officialTitle": "Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV", "protocolId": "2018P001792", "sponsor": "Massachusetts General Hospital", "status": "COMPLETED", "statusVerified": "2022-07", "firstPosted": "2019-02-01", "lastUpdatePosted": "2022-07-19", "start": { "date": "2019-01-30", "type": "ACTUAL" }, "primaryCompletion": { "date": "2022-04-19", "type": "ACTUAL" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 23, "type": "ACTUAL" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "Tesamorelin", "description": "Individuals who plan to initiate tesamorelin clinically" }, { "label": "No Treatment", "description": "Individuals who decline to initiate tesamorelin despite a clinical indication" } ], "primaryOutcomes": [ { "measure": "Intramyocardial lipid content", "description": "Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)", "timeFrame": "6 months" } ], "resultsFirstPosted": null, "conditions": [ "Human Immunodeficiency Virus", "Lipodystrophy", "Cardiac Disease" ], "interventions": [], "briefSummary": "Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT03826160", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03826160" }, { "id": "NCT03878706", "title": "The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination", "officialTitle": "The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk", "protocolId": "2790/03-11-2017", "sponsor": "University of Athens", "status": "RECRUITING", "statusVerified": "2026-03", "firstPosted": "2019-03-18", "lastUpdatePosted": "2026-03-13", "start": { "date": "2017-11-03", "type": "ACTUAL" }, "primaryCompletion": { "date": "2026-12-31", "type": "ESTIMATED" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 240, "type": "ESTIMATED" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "GLP1 and SGLT2i group", "description": "60 patients treated with a combination of liraglutide and empagliflozin. All subjects will undergo an echocardiographic study to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using Sideview Darkfield Imaging (Microscan, Glycockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and lipid profile will be measured before and at 6 and 12 months of treatment." }, { "label": "GLP1 group", "description": "60 patients treated with liraglutide. All subjects will undergo an echocardiographic study in order to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using Sideview Darkfield Imaging (Microscan, Glycockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 6 and 12 months of treatment." }, { "label": "SGLT2i group", "description": "60 patients treated with empagliflozin. All subjects will undergo an echocardiographic study in order to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using Sideview Darkfield Imaging (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 6 and 12 months of treatment." }, { "label": "Control group", "description": "60 patients treated with insulin and metformin.All subjects will undergo an echocardiographic study in order to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of subglottic vessels using Sideview Darkfield Imaging (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 6 and 12 months of treatment." } ], "primaryOutcomes": [ { "measure": "Comparison of Global Longitudinal Strain (GLS) difference among treatment groups.", "description": "Comparison of Global Longitudinal Strain (GLS) difference among treatment groups, measured by echocardiographic study", "timeFrame": "12 months" } ], "resultsFirstPosted": null, "conditions": [ "Diabetes Mellitus, Type 2" ], "interventions": [], "briefSummary": "A. Four groups of patients with type 2 diabetes mellitus with high or very high cardiovascular risk or heart failure with preserved ejection fraction (HFpEF) will be studied before and at 6 and 12 months of treatment:\n\n* 60 patients treated with a combination of GLP1 analogue and SGLT2 inhibitor ± metformin\n* 60 patients treated with GLP-1 agonist as a second step after metformin\n* 60 patients treated with SGLT2 inhibitor as a second step after metformin\n* 60 patients treated with a combination of insulin and other antidiabetic agents (metformin - DPP4 inhibitors) Individuals will be equal distributed as far as age, gender and body mass index concerned. In addition, patients suffered from kidney disease and retinopathy are excluded.", "detailedDescription": "Disordered glucose tolerance in patients with type 2 diabetes mellitus is multifactorial and includes dysfunction not only of β-cells of the pancreas, liver and muscles, but also of the adipose tissue, gastrointestinal tract, kidney, α-cells of the pancreas and the brain. Therefore, it is likely that the use of drugs that act on multiple aspects of the pathophysiology of diabetes will have beneficial effects on glycemic control and outcome of patients.In addition to the many possible causes of glucose deregulation, people with type 2 diabetes have comorbidities such as hypertension, hyperlipidemia and obesity resulting in increased cardiovascular risk. Optimal treatment of hyperglycaemia and cardiovascular risk factors is necessary to reduce adverse events. Although the initial approach is the modification of dietary factors (physical activity, diet, smoking cessation), the progressive nature of type 2 diabetes ultimately leads to the use of multiple therapies. Guidelines for the treatment of patients with type 2 diabetes with high HbA1c are initial double-combined therapy or triple combination if glycemic control is not achieved after 3 months. Although insulin is usually included in such combinations, additional treatment options are required for patients with high HbA1c who also need to lose weight and avoid hypoglycaemia. It is likely that the outcome of patients could be improved by using drugs targeting different aspects of the disease (glycemia, body weight, blood pressure, lipids).\n\nOver the last decade, two classes of antidiabetic drugs have been added to weight loss, improved cardiovascular risk factors and a low risk of hypoglycemia: glucagon-like peptide-1 agonists (GLP-1, glucagon like peptide-1) and inhibitors of the sodium glucose subtype 2 (SGLT2, sodium-glucose co-transporters). Recent studies have shown that these two drugs have cardioprotective effects possibly through different mechanisms of action, while their complementary mechanical, pharmacological and clinical effects make their combination (in addition to metformin) potentially beneficial in type 2 diabetes patients. Specifically, SGLT2 inhibitors manifest their cardioprotective activity by improving hemodynamic parameters, while GLP-1 agonists through antiatherogen / anti-inflammatory mechanisms.\n\nThe increased arterial stiffness with the associated increase in the range of reflected pressure waves, determines not only the augmentation of systolic pressure but also the rate of increase which depends on age. Increased levels of pulse pressure (indirect atherosclerotic index) and pulse wave velocity (PWV), a reliable measure of arterial stiffness, predict future cardiovascular events. Endothelial dysfunction is associated with the presence of atherosclerosis and is also considered as an indicator of the early changes preceding it. The role of impaired endothelial function of large arteries seems to be significant in the pathogenesis of cardiovascular disease. Endothelial glycocalyx is a glycoprotein layer that covers the surface of endothelial cells and regulates arterial wall permeability and the interaction of endothelial cells with circulating blood cells. Inflammatory or atherogenic stimuli, such as hyperglycemia, lead to glucocalyx disorder and increased vascular sensitivity to further atherogenic stimuli. The two-dimensional speckle tracking ultrasound allows accurate estimation of left ventricular distortion, which is disordered in diabetics in relation to healthy subjects.\n\nHypothesis of the proposed study:\n\nEndothelial function, arterial stiffness and left ventricular deformation are improved in patients with type 2 diabetes with high or very high cardiovascular risk or heart failure with preserved ejection fraction (HFpEF) treated with GLP-1 agonist and SGLT2 inhibitor compared to either one or both combination of insulin and other antidiabetic tablets.\n\nAim of the study:\n\nThe aim of this study is to investigate the effect of GLP-1 agonist, SGLT2 inhibitor and their combination on endothelial function, arterial stiffness, central hemodynamic characteristics and left ventricular deformation in patients with type 2 diabetes with high or very high cardiovascular risk or HFpEF and compared with the combination of insulin and other antidiabetic tablets.\n\nMaterials and methods :\n\nA. Four groups of patients with type 2 diabetes mellitus with high or very high cardiovascular risk or HFpEF will be studied before and at 6 and 12 months of treatment:\n\n* 60 patients treated with a combination of GLP1 analogue and SGLT2 inhibitor ± metformin\n* 60 patients treated with GLP-1 agonist as a second step after metformin\n* 60 patients treated with SGLT2 inhibitor as a second step after metformin\n* 60 patients treated with a combination of insulin and other antidiabetic agents (metformin - DPP4 inhibitors) Individuals will be equal distributed as far as age, gender and body mass index concerned. In addition, patients suffered from kidney disease and retinopathy are excluded.\n\nB. All patients will be submitted to an echocardiographic study in order to estimate the total left ventricular and atrial myocardial global longitudinal strain (GLS) as well as the twisting-untwisting of the left ventricle using speckle tracking imaging. In addition, pulse wave velocity (PWV, measured in m/s), pulse wave augmentation index \\[AIx %, which is calculated by the formula (P2-P1)/PP x 100, where P1 stands for peak systolic pressure, P2 stands for second peak systolic pressure due to wave reflection and PP stands for Pulse Pressure\\], central systolic blood pressure (SBPao, measured in mm Hg) and central pulse pressure (PPao, measured in mm Hg) with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels (5-25 μm in size) using a high-resolution camera with Sideview Darkfield Imaging technique (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Increased PBR is considered to be an accurate indicator of the reduction of endothelial glycocalyx thickness due to plasma penetration into the glycocalyx.\n\nΜalondialdehyde (MDA), protein carbonyls (PC) as oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin HbA1c and a full lipidemic profile will be measured before and at 6 months and at 12 months of treatment.\n\nAlso, the incidence of non-fatal major cardiovascular events (myocardial infarction, heart failure hospitalization, ischemic stroke) will be nored via performing telephonic follow-up during a long-term follow-up of six years. Accordingly, a cost analysis will be conducted to evaluate and compare the economic outcomes of the four treatment arms.\n\nThe examination will be carried out at the Laboratory of Preventive Cardiology of the 2nd Department of Cardiology of the University of Athens at \"Attikon\" Hospital. Τhe investigators will also compare the participants with history of coronary artery disease with those without hisotry of coronary artery disease.\n\nC. For the statistical analysis of the results, the significance of each intervention will be measured by t-test and the 4 groups will be compared by ANOVA (post-hoc comparisons with Bonferroni correction). Non-parametric tests will be used for non-Gaussian distributions. Forty individuals should be included in each group in order the results being statistically significant. In a previous study, myocardial global longitudinal strain of the left ventricle showed normal distribution with standard deviation 10. A true difference in mean left ventricular myocardial distortion between the intervention group (GLP-1 agonist compined with SGLT2 inhibitor) and a control one (combination of insulin and other antidiabetic tablets) which is calculated of -6.344% or 6.344% will be calculated with probability 0.8. The probability of a type I error if the null hypothesis is that the mean difference between the two groups is equal, is equivalent to 0.05.\n\nSignificance/future prospects:\n\nThis study is expected to open the horizons of better understanding the cardiovascular benefits of GLP-1 agonist, SGLT2 inhibitor and their combination in patients with type 2 diabetes mellitus. Moreover, the contribution of the investigator's results, in a clinical-level could be the use of new drug therapies that reduce both microvascular complications by reducing glycemia and macrovascular complications (myocardial infarction, stroke, cardiovascular mortality) as the first treatment line in patients with type 2 diabetes with high or very high cardiovascular risk.", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT03878706", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03878706" }, { "id": "NCT04027712", "title": "Platelet Reactivity, B-amyloid, MOTS-c and Mortality of Type II Diabetics With CAD", "officialTitle": "High On-treatment Platelet Reactivity, Increased B-amyloid and Downregulation of MOTS-c Predict Mortality in Patients With Coronary Artery Disease and Type 2 Diabetes Mellitus: a 2-year Follow up Study", "protocolId": "LTA_MOTS-c_bamyloid_DM_CAD", "sponsor": "University of Athens", "status": "UNKNOWN", "statusVerified": "2019-07", "firstPosted": "2019-07-22", "lastUpdatePosted": "2019-07-23", "start": { "date": "2014-01-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2019-12-31", "type": "ESTIMATED" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 120, "type": "ESTIMATED" }, "designInfo": { "observationalModel": "CASE_ONLY", "timePerspective": "PROSPECTIVE" }, "arms": [], "primaryOutcomes": [ { "measure": "mots-c predicts cardiovascular mortality in diabetic with coronary artery disease", "description": "mots-c concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality", "timeFrame": "2 year follow up" }, { "measure": "b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease", "description": "b amyloid concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality", "timeFrame": "2 year follow up" }, { "measure": "b amyloid predicts cardiovascular mortality in diabetic with coronary artery", "description": "Resistance to clopidogrel as defined by Light Transmission Aggregometry in diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality.", "timeFrame": "2 year follow up" } ], "resultsFirstPosted": null, "conditions": [ "Diabetes", "Clopidogrel Resistance", "Amyloid", "Insulin Resistance" ], "interventions": [], "briefSummary": "Increased circulating b-amyloid and decreased Mitochondrial-derived peptide (MOTS-c), a peptide improving tissue insulin sensitivity, are reported in diabetes. The investigators plan to investigate the association of both biofactors with high on-clopidogrel platelet reactivity and cardiovascular mortality in type 2 diabetic patients with Coronary artery disease", "detailedDescription": "In type II diabetic patients with Coronary artery disease treated with clopidogrel and aspirin, the investigators plan to measure: i. maximum platelet aggregation to adenosine diphosphate (ADP) by Light Transmission Aggregometry (LTAmax), as a marker of on-clopidogrel treatment platelet reactivity ii. Malondialdehyde (MDA), as oxidative stress marker, Mitochondrial-derived peptide MOTS-c and b-amyloid. blood levels.", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT04027712", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT04027712" }, { "id": "NCT06133946", "title": "Cohort Of DEafness-gene Screening", "officialTitle": "Cohort of Universal Newborn Deafness-gene Screening in Nantong City, China", "protocolId": "BE2015655", "sponsor": "Affiliated Hospital of Nantong University", "status": "ACTIVE_NOT_RECRUITING", "statusVerified": "2023-11", "firstPosted": "2023-11-18", "lastUpdatePosted": "2023-11-18", "start": { "date": "2016-01-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2021-03-31", "type": "ACTUAL" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 35920, "type": "ACTUAL" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "Combined screening", "description": "All newborns underwent combined hearing and genetic screening.", "interventionNames": [ "Genetic: Genetic screening test (Deafness gene variant detection array kit)" ] } ], "primaryOutcomes": [ { "measure": "Diagnosis of hearing loss at age of 3 months", "description": "Diagnosis of HL was confirmed by hearing diagnostic tests (ABR+ASSR) at age of 3 months.\n\nAuditory steady-state response (ASSR) were used as an alternative and adjunct to the auditory brainstem response (ABR) for threshold estimation.", "timeFrame": "From Jan 1, 2016 to Mar 31, 2021" } ], "resultsFirstPosted": null, "conditions": [ "Hearing Loss" ], "interventions": [ { "type": "GENETIC", "name": "Genetic screening test (Deafness gene variant detection array kit)" } ], "briefSummary": "This study was based on a concurrent newborn genetic and hearing screening program in Nantong city. From January 2016 to December 2020, newborn infants were recruited and received combined screening for free, funded in part by the municipal government and research project foundations. The population-based longitudinal databank for all children with hearing loss in Nantong city commenced in January 2016 and maintained indefinite recruitment and ongoing follow-up.", "detailedDescription": "The severity of hearing loss was graded as mild (26-40 dB), moderate (41-60 dB), severe (61-80 dB), and profound (≥81 dB).\n\nGenomic DNA was extracted by a blood filter paper nucleic acid extraction kit (CapitalBio, Beijing, China) and tested using a deafness gene variant detection array kit (CapitalBio, Beijing, China) with LuxScan 10K-B Microarray Scanner (CapitalBio, Beijing, China). The genetic screening entailed genotyping 15 variants in 4 genes: c.35delG, c.176\\_191del16, c.235delC, c.299\\_300delAT (GJB2 gene); c.1174A\\>T, c.1226G\\>A, c.1229C\\>T, c.1975G\\>C, c.2027T\\>A, c.2168A\\>G, c.IVS7-2A\\>G, c.IVS15 + 5G\\>A (SLC26A4 gene); m.1494C\\>T, m.1555A\\>G (MT-RNR1 gene); c.538C\\>T (GJB3 gene). The results were categorized as (1) negative, (2) carrier (GJB2 or SLC26A4, heterozygous mutations; MT-RNR1 mutations; GJB3 mutations; or heterozygous mutations in multiple genes), and (3) refer (GJB2 or SLC26A4, homozygous or compound heterozygous mutations).\n\nThis study was approved by the ethics committees of Nantong municipal Health Commission and all hospitals involved. Written informed consent was obtained from the infant's parents.\n\nThis study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT06133946", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06133946" }, { "id": "NCT06500975", "title": "Long Term Outcomes After Vestibular Implantation", "officialTitle": "Long Term Outcomes After Vestibular Implantation", "protocolId": "IRB00434328", "sponsor": "Johns Hopkins University", "status": "RECRUITING", "statusVerified": "2026-03", "firstPosted": "2024-07-15", "lastUpdatePosted": "2026-03-09", "start": { "date": "2024-12-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2029-12", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 32, "type": "ESTIMATED" }, "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "Vestibular Implant", "type": "EXPERIMENTAL", "description": "Up to 32 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System (MVI)", "interventionNames": [ "Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant System" ] } ], "primaryOutcomes": [ { "measure": "PM1.1: Dynamic Gait Index (DGI)18 during motion-modulated implant stimulation at 4 years post-implantation, relative to pre-operative baseline, aggregated across all implant users.", "description": "DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.", "timeFrame": "4 years post-implantation up to 5 years post-enrollment" }, { "measure": "PM1.2: Gain (VHITG) of the vestibulo-ocular reflex (VOR), as measured using the video head impulse test (vHIT)", "description": "During video head impulse testing (vHIT), rotational eye and head movement are measured by a goggle-mounted camera and motion sensor during brief, fast \\~10 degree head rotations about the axis of a semicircular canal being tested. Performance is quantified by vestibulo-ocular reflex (VOR) gain, which a ratio of eye movement to head movement (in this case the integral of eye velocity relative to the head and the additive inverse of the integral of head velocity, respectively). VHITG, the average vHIT VOR gain for each of the three semicircular canals of the implanted ear, typically ranges from 0 to 1, with higher numbers indicating better performance.", "timeFrame": "4 years post-implantation up to 5 years post-enrollment" } ], "resultsFirstPosted": null, "conditions": [ "Bilateral Vestibular Hypofunction", "Bilateral Vestibular Deficiency", "Bilateral Vestibulopathy", "Gentamicin Ototoxicity", "Aminoglycoside Toxicity", "Vestibular Diseases", "Sensation Disorders", "Labyrinth Diseases", "Other Disorders of Vestibular Function" ], "interventions": [ { "type": "DEVICE", "name": "Labyrinth Devices MVI™ Multichannel Vestibular Implant System" } ], "briefSummary": "Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.", "detailedDescription": "There is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of semicircular canal function despite vestibular rehabilitation exercises. The experience of 15 adults with bilateral vestibular hypofunction who underwent unilateral surgical placement of a vestibular implant and have received continuously motion-modulated electrical stimulation of the vestibular nerve for \\>6 months revealed vestibular implantation (VI) and motion-modulated stimulation can partially restore vestibular sensation and reflexes that normally maintain steady posture and vision. This study will examine long-term outcomes after vestibular implantation. Within constraints on power and/or minimum detectable effect size due to limits on the number of study participants permitted under IDE G150198, the study will test the following hypotheses regarding unilateral vestibular implantation, activation and long-term (≥3 years) continuous/daily use:\n\n1. It is safe, as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of:\n\n 1. implanted ears with preservation of 4-frequency pure tone average for 0.5,1,2,4 kHz air-conducted audiometric detection thresholds ≤ 50 decibel (dB) HL and ear-specific speech discrimination ≥50% (consistent with Class A or B per American Academy of Otolaryngology-Head and Neck Surgery 1995 guidelines 13 ) or ≤ 30 dB change from preoperative baseline (if preoperative baseline is ≥20 dBHL) and ear-specific speech discrimination ≤30% worse than preoperative baseline (if preoperative baseline is ≤80%)\n 2. participants with preservation of useful sound-field hearing by the above criteria, and\n 3. implanted ears with preservation of otolith endorgan function, if present pre-operatively\n2. It is tolerable, as quantified by duration of compliance with use.\n3. It is efficacious, as defined by nonzero improvement with respect to preoperative baseline gait stability as quantified by Dynamic Gait Index (DGI) and vestibulo-ocular reflex gain during passive head impulse rotation (VHITG) .", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT06500975", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06500975" }, { "id": "NCT06554717", "title": "Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV", "officialTitle": "Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV", "protocolId": "2024P001703", "sponsor": "Massachusetts General Hospital", "status": "RECRUITING", "statusVerified": "2026-05", "firstPosted": "2024-08-15", "lastUpdatePosted": "2026-05-19", "start": { "date": "2025-07-10", "type": "ACTUAL" }, "primaryCompletion": { "date": "2028-06-16", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 100, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Tesamorelin Plus Exercise", "type": "ACTIVE_COMPARATOR", "description": "Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention", "interventionNames": [ "Drug: Tesamorelin", "Behavioral: Exercise" ] }, { "label": "Placebo Plus Exercise", "type": "PLACEBO_COMPARATOR", "description": "Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention", "interventionNames": [ "Drug: Placebo", "Behavioral: Exercise" ] } ], "primaryOutcomes": [ { "measure": "Change in Repeated Chair Stand Time", "description": "Time to complete 10 repeated chair stands", "timeFrame": "Baseline to Week 24" } ], "resultsFirstPosted": null, "conditions": [ "HIV-1-infection", "Frailty", "Impaired Physical Function", "Abdominal Obesity", "Aging" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Placebo" }, { "type": "BEHAVIORAL", "name": "Exercise" } ], "briefSummary": "People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in doing so than in the general population and is difficult to sustain in the long-term.\n\nThe goal of this clinical trial is to learn whether the medication tesamorelin will improve physical function and muscle health in adults with HIV when combined with exercise. Tesamorelin is a growth hormone-releasing hormone analogue that is FDA-approved to treat abdominal fat accumulation in people with HIV. While tesamorelin has also been shown to increase muscle mass and improve measures of muscle health, its effects on physical performance and muscle strength have not yet been evaluated.\n\nDuring a 24-week intervention phase, half of participants will be randomly assigned to receive tesamorelin and half of participants will be randomly assigned to receive placebo (a look-alike substance that contains no drug). All participants also will engage in a home-based exercise intervention supervised by an exercise coach. During a subsequent 24-week extension phase, individuals will be monitored off study drug and supervised exercise, and be encouraged to continue to exercise independently.\n\nThe investigators will investigate effects of tesamorelin on physical function, muscle mass and quality, quality of life, and exercise adherence and self-efficacy. They also will evaluate whether effects of tesamorelin are maintained following treatment cessation. This study may identify an important strategy to improve how individuals aging with HIV function and feel with potential applications to other patient populations.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT06554717", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06554717" }, { "id": "NCT07437547", "title": "BPC 157 for Acute Hamstring Muscle Strain Repair", "officialTitle": "A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Pentadecapeptide BPC 157 for Accelerated Repair of Acute Grade II Hamstring Strain Confirmed by MRI", "protocolId": "BH-BPC157-MUSC-001", "sponsor": "Hudson Biotech", "status": "RECRUITING", "statusVerified": "2026-02", "firstPosted": "2026-02-27", "lastUpdatePosted": "2026-02-27", "start": { "date": "2026-02-02", "type": "ACTUAL" }, "primaryCompletion": { "date": "2027-02-14", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 120, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Participants with an acute MRI-confirmed grade II hamstring strain are randomized 1:1 to investigational BPC 157 or placebo. Both groups receive the same standardized rehabilitation program.", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "Investigational pharmacy prepares identical-appearing prefilled syringes labeled with a randomization code. Participants, study clinicians, investigators, and outcome assessors remain blinded to assignment. Emergency unblinding is permitted only when necessary for participant safety.", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Arm 1: Experimental - BPC 157", "type": "EXPERIMENTAL", "description": "Participants receive investigational pentadecapeptide BPC 157 plus standardized rehabilitation.", "interventionNames": [ "Drug: Pentadecapeptide BPC 157", "Drug: Placebo" ] }, { "label": "Arm 2: Placebo Comparator - Placebo", "type": "EXPERIMENTAL", "description": "Participants receive matching placebo plus standardized rehabilitation.", "interventionNames": [ "Drug: Pentadecapeptide BPC 157", "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "Time to return to unrestricted sport participation (days)", "description": "defined as clearance by a blinded sports medicine clinician and completion of a standardized functional performance battery without pain-limited stopping.", "timeFrame": "8 Weeks" }, { "measure": "Change from baseline to Day 14 in MRI-assessed hamstring injury volume (cm^3), measured by blinded central radiology review.", "timeFrame": "14 Days" } ], "resultsFirstPosted": null, "conditions": [ "Hamstring Muscle Strain", "Skeletal Muscle Injury" ], "interventions": [ { "type": "DRUG", "name": "Pentadecapeptide BPC 157" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "This randomized, double-blind, placebo-controlled Phase 2 study evaluates whether pentadecapeptide BPC 157 (BPC-157), an investigational peptide, can speed structural healing and functional recovery after an acute grade II hamstring muscle strain. Participants will receive BPC 157 or placebo for 14 days in addition to a standardized rehabilitation program. The co-primary endpoints are time to return to unrestricted sport and change in MRI-assessed injury volume at Day 14.", "detailedDescription": "Acute hamstring strains are common in running- and field-based sports and often lead to prolonged time away from sport and a risk of recurrence. Preclinical research suggests that BPC 157 may influence pathways involved in tissue protection, angiogenesis, and repair. Human clinical evidence remains limited, so a controlled trial is needed to evaluate potential benefits and characterize safety in a musculoskeletal injury population. After screening and baseline assessments (including MRI confirmation of an acute grade II hamstring strain), eligible participants will be randomized 1:1 to receive subcutaneous BPC 157 or matching placebo once daily for 14 days. All participants will follow the same evidence-based rehabilitation protocol supervised by study physiotherapists. Clinical assessments will occur at Days 3, 7, 14, 28, and 56, with additional follow-up at 3 months after return-to-play for recurrence monitoring. Safety will be assessed through adverse event monitoring, vital signs, and standard laboratory tests. An independent Data and Safety Monitoring Committee will review unblinded safety data at predefined intervals.", "hasResults": false, "matchedQueries": [ "\"BPC-157\" OR \"BPC 157\"" ], "url": "https://clinicaltrials.gov/study/NCT07437547", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07437547" }, { "id": "NCT07437586", "title": "Topical GHK-Cu Gel for Acute Skin Wound Healing", "officialTitle": "A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Split-Wound Study of Topical GHK-Cu (Copper(II)-Peptide Complex) Gel to Accelerate Re-Epithelialization of Standardized Acute Skin Wounds in Healthy Adults", "protocolId": "GCU-WH-001", "sponsor": "Hudson Biotech", "status": "RECRUITING", "statusVerified": "2026-02", "firstPosted": "2026-02-27", "lastUpdatePosted": "2026-02-27", "start": { "date": "2026-02-02", "type": "ACTUAL" }, "primaryCompletion": { "date": "2027-02-14", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 60, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Each participant receives two standardized wounds; one wound is randomized to GHK-Cu gel and the other to vehicle gel. This paired design controls for participant-level factors (e.g., age, genetics) that influence healing.", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "GHK-Cu and vehicle gels are identical in appearance, packaging, and labeling. Randomization codes are held by an independent pharmacist/biostatistician. Blinded assessors evaluate standardized photographs.", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: GHK-Cu Gel (Copper(II)-peptide complex)", "Drug: vehicle Gel (placebo comparator)" ] }, { "label": "Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: GHK-Cu Gel (Copper(II)-peptide complex)", "Drug: vehicle Gel (placebo comparator)" ] } ], "primaryOutcomes": [ { "measure": "Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography.", "timeFrame": "21 Days" } ], "resultsFirstPosted": null, "conditions": [ "Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)" ], "interventions": [ { "type": "DRUG", "name": "GHK-Cu Gel (Copper(II)-peptide complex)" }, { "type": "DRUG", "name": "vehicle Gel (placebo comparator)" } ], "briefSummary": "This study will evaluate whether a topical gel containing GHK-Cu (a copper(II)-peptide complex) can safely speed up healing of small, standardized skin wounds in healthy adults compared with a matching vehicle gel.\n\nParticipants will receive two small punch-biopsy wounds on the upper arm; each wound will be randomly assigned to receive GHK-Cu gel or vehicle gel under identical dressings. Wounds will be photographed and assessed over 3 weeks, with a follow-up visit to evaluate scar quality.", "detailedDescription": "GHK (glycyl-L-histidyl-L-lysine) is a naturally occurring human peptide that can form a stable complex with copper(II) (GHK-Cu). Preclinical and mechanistic literature suggests GHK-Cu may influence processes relevant to tissue repair such as extracellular matrix remodeling, angiogenesis, and inflammation. This proof-of-concept study uses a standardized acute wound model (paired punch-biopsy wounds) to reduce variability and enable a controlled comparison. Study objectives Primary objective: Determine whether topical GHK-Cu gel reduces time to complete re-epithelialization versus vehicle. Secondary objectives: Evaluate wound area reduction over time, local symptoms (pain/itch), infection rate, scar quality at 12 weeks, and safety/tolerability. Study procedures (overview) Day 0: Two 5-mm punch-biopsy wounds will be created under local anesthetic on the non-dominant upper arm. Wounds will be randomized (1:1) to receive GHK-Cu gel or vehicle gel. Study products will be applied once daily for 14 days under standardized non-adherent dressings. Follow-up: In-clinic assessments with standardized digital photography and clinical evaluation on Days 3, 7, 10, 14, and 21 (or until healed). Remote check-ins may be used for interim safety and adherence.\n\nWeek 12: Scar assessment (POSAS) and final safety review.", "hasResults": false, "matchedQueries": [ "\"GHK-Cu\" OR \"GHK Cu\"" ], "url": "https://clinicaltrials.gov/study/NCT07437586", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07437586" }, { "id": "NCT07438002", "title": "Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment", "officialTitle": "Effect of Exercise in Patients With Chronic Kidney Disease: TONE Trial", "protocolId": "573CET", "sponsor": "Casa di Cura Dott. Pederzoli", "status": "RECRUITING", "statusVerified": "2026-02", "firstPosted": "2026-02-27", "lastUpdatePosted": "2026-02-27", "start": { "date": "2025-09-02", "type": "ACTUAL" }, "primaryCompletion": { "date": "2026-09", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 50, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "OTHER", "maskingInfo": { "masking": "SINGLE", "whoMasked": [ "PARTICIPANT" ] } }, "arms": [ { "label": "combined exercise", "type": "EXPERIMENTAL", "description": "participants will undergo a combined endurance and resistance exercise training", "interventionNames": [ "Other: Exercise" ] }, { "label": "control group", "type": "ACTIVE_COMPARATOR", "description": "participants performs outcome measures sessions only, including blood sample collection.", "interventionNames": [ "Other: control" ] } ], "primaryOutcomes": [ { "measure": "Gait speed (6MWT)", "description": "• Assess the effect of exercise on physical performance and quality of life on pa-tients with chronic kidney disease from stage 1 to end stage renal disease on maintenance haemodialysis or on conservative treatment", "timeFrame": "through study completion, an average of 1 year" }, { "measure": "Physical performance (SPPB)", "timeFrame": "through study completion, an average of 1 year" }, { "measure": "Cardiopulmonary capacity (CPET)", "timeFrame": "through study completion, an average of 1 year" }, { "measure": "Lower limbs strength (1-RM)", "timeFrame": "through study completion, an average of 1 year" }, { "measure": "Maximum isometric strength of the upper limb (hand grip)", "timeFrame": "through study completion, an average of 1 year" }, { "measure": "Daily physical activity amount (IPAQ)", "timeFrame": "through study completion, an average of 1 year" }, { "measure": "Quality of life (SF36)", "timeFrame": "through study completion, an average of 1 year" } ], "resultsFirstPosted": null, "conditions": [ "Chronic Kidney Disease" ], "interventions": [ { "type": "OTHER", "name": "Exercise" }, { "type": "OTHER", "name": "control" } ], "briefSummary": "This study aims to analyze the effects of physical activity in patients with chronic kidney disease undergoing dialysis or conservative treatment. Patients will be randomized into two groups: combined exercise (high-intensity aerobic resistance + strength training) and control group", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT07438002", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07438002" }, { "id": "NCT07481734", "title": "Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)", "officialTitle": "A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)", "protocolId": "TESA-MASLD-201", "sponsor": "Hudson Biotech", "status": "RECRUITING", "statusVerified": "2026-03", "firstPosted": "2026-03-19", "lastUpdatePosted": "2026-03-19", "start": { "date": "2026-02-02", "type": "ACTUAL" }, "primaryCompletion": { "date": "2027-02-14", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 120, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Two-arm, randomized, double-blind, placebo-controlled design. All participants receive standardized lifestyle counseling. Treatment duration is 52 weeks with 4-week post-treatment safety follow-up.", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Tesamorelin and placebo are identical in appearance and packaging. Randomization codes are held by an independent pharmacy. An unblinded endocrinology safety monitor may recommend protocol-defined dose reduction based on IGF-1 thresholds without revealing assignment to the study team.", "whoMasked": [ "PARTICIPANT" ] } }, "arms": [ { "label": "Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: Tesamorelin", "Drug: Placebo", "Behavioral: Standardized lifestyle counseling" ] }, { "label": "Placebo Comparator: Matching placebo subcutaneous once daily", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: Tesamorelin", "Drug: Placebo", "Behavioral: Standardized lifestyle counseling" ] } ], "primaryOutcomes": [ { "measure": "Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)", "description": "MRI-PDFF performed at baseline and week 52; central blinded read.", "timeFrame": "52 weeks" } ], "resultsFirstPosted": null, "conditions": [ "Metabolic Associated Steatotic Liver Disease", "Nonalcoholic Steatohepatitis", "Hepatic Steatosis" ], "interventions": [ { "type": "DRUG", "name": "Tesamorelin" }, { "type": "DRUG", "name": "Placebo" }, { "type": "BEHAVIORAL", "name": "Standardized lifestyle counseling" } ], "briefSummary": "This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease. Participants receive tesamorelin or matching placebo for 52 weeks, with standardized lifestyle counseling in both groups. Liver fat is quantified by MRI-proton density fat fraction (MRI-PDFF). Key safety monitoring includes glucose metrics and IGF-1.", "detailedDescription": "Fatty liver disease (MASLD/NAFLD) is common and may progress to steatohepatitis and fibrosis. There are limited pharmacologic options that directly and durably reduce hepatic steatosis while also improving metabolic risk. Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that increases endogenous pulsatile growth hormone secretion and can influence lipid metabolism. Prior randomized studies of tesamorelin have shown reductions in hepatic fat fraction in populations with NAFLD, using magnetic-resonance-based quantification and paired histology in subsets. The primary efficacy endpoint is change in liver fat (MRI-PDFF) from baseline to week 52. Secondary endpoints include MRI-PDFF responder rate (\\>=30% relative decline), changes in liver enzymes and noninvasive fibrosis measures, metabolic outcomes (glucose, HbA1c, HOMA-IR, lipids), and safety/tolerability outcomes. In this mock protocol, eligible adults with elevated liver fat on MRI-PDFF are randomized 1:1 to tesamorelin or placebo. Study medication is self-administered once daily by subcutaneous injection.\n\nDose reduction rules are included for elevated IGF-1 while preserving the blind.\n\nParticipants complete study visits at baseline and at weeks 4, 12, 24, 36, and 52 (end of treatment), plus a safety follow-up at week 56. MRI-PDFF is performed at baseline, week 24, and week 52. Transient elastography (FibroScan) and standard laboratory panels are collected at prespecified visits. A voluntary liver-biopsy sub-study is offered to evaluate histologic activity and fibrosis.", "hasResults": false, "matchedQueries": [ "\"Tesamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT07481734", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07481734" }, { "id": "NCT07487363", "title": "TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD", "officialTitle": "A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of TB-500 (Thymosin Beta 4 17-23 Fragment) in Adults With Stable Atherosclerotic Cardiovascular Disease to Evaluate Safety, Tolerability, Pharmacokinetics, and Exploratory Cardiovascular Biomarkers", "protocolId": "TB500-CV-101", "sponsor": "Hudson Biotech", "status": "RECRUITING", "statusVerified": "2026-03", "firstPosted": "2026-03-23", "lastUpdatePosted": "2026-03-23", "start": { "date": "2026-02-05", "type": "ACTUAL" }, "primaryCompletion": { "date": "2027-02-14", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1", "PHASE2" ], "enrollment": { "count": 80, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": "Three sequential dose cohorts with a randomized, parallel placebo control within each cohort (3:1 TB-500:placebo). Dose escalation proceeds after safety review.", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "SINGLE", "maskingDescription": "TB-500 and placebo are identical in appearance/packaging. Randomization codes are maintained by an unblinded pharmacist or designee; participants, treating clinicians, investigators, and outcome assessors remain blinded.", "whoMasked": [ "PARTICIPANT" ] } }, "arms": [ { "label": "TB-500 Low Dose", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: TB-500", "Drug: Placebo" ] }, { "label": "TB-500 Medium Dose", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: TB-500", "Drug: Placebo" ] }, { "label": "TB-500 High Dose", "type": "EXPERIMENTAL", "interventionNames": [ "Drug: TB-500", "Drug: Placebo" ] }, { "label": "Matching placebo", "type": "PLACEBO_COMPARATOR", "interventionNames": [ "Drug: TB-500", "Drug: Placebo" ] } ], "primaryOutcomes": [ { "measure": "incidence of treatment-emergent adverse events (TEAEs)", "description": "Proportion of participants with at least one TEAE/SAE; severity and relationship assessed by investigator.", "timeFrame": "12 weeks" }, { "measure": "Incidence of serious adverse events (SAEs)", "timeFrame": "28 Days" } ], "resultsFirstPosted": null, "conditions": [ "Atherosclerotic Cardiovascular Diseases", "Endothelial Dysfunction" ], "interventions": [ { "type": "DRUG", "name": "TB-500" }, { "type": "DRUG", "name": "Placebo" } ], "briefSummary": "This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1/2 trial evaluating the safety and tolerability of TB-500 (a 17-23 fragment of thymosin beta 4) versus placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Exploratory endpoints assess vascular function and inflammation biomarkers", "detailedDescription": "This example record models common ClinicalTrials.gov data elements for an interventional study. Design overview: Participants with stable ASCVD will be enrolled into three sequential dose cohorts. Within each cohort, participants are randomized in a 3:1 ratio to TB-500 or matching placebo. Masking is maintained for participants, care providers, investigators, and outcome assessors. Intervention period: Study drug is administered by trained clinic staff during scheduled on-site visits over an 8-week dosing period, followed by a 4-week safety follow-up. The specific dose levels are protocol-defined and are not provided in this public example. Assessments: Safety assessments include adverse events, concomitant medications, physical examinations, vital signs, clinical laboratory testing, and 12-lead ECG. Exploratory cardiovascular assessments include brachial artery flow-mediated dilation (FMD) and blood-based biomarkers of inflammation and cardiac stress. Escalation and oversight: An independent safety review committee evaluates cumulative safety data after each cohort completes early follow-up before enrollment begins in the next cohort.", "hasResults": false, "matchedQueries": [ "\"TB-500\" OR \"TB500\"" ], "url": "https://clinicaltrials.gov/study/NCT07487363", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07487363" }, { "id": "NCT07505745", "title": "MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity", "officialTitle": "A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c (a Mitochondrial-Derived Peptide) in Adults With Prediabetes and Overweight/Obesity", "protocolId": "EX-MOTS-2A-001", "sponsor": "Hudson Biotech", "status": "RECRUITING", "statusVerified": "2026-03", "firstPosted": "2026-04-01", "lastUpdatePosted": "2026-04-01", "start": { "date": "2026-02-02", "type": "ACTUAL" }, "primaryCompletion": { "date": "2027-02-14", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "enrollment": { "count": 120, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Two-arm, multicenter, randomized, double-blind, placebo-controlled, parallel-group design (1:1 allocation).", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "MOTS-c and placebo are identical in appearance and packaging. Randomization codes are held by an unblinded pharmacist/interactive response system; participants, site staff, investigators, and outcome assessors remain blinded until database lock (except for emergency unblinding).", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "MOTS-c", "type": "EXPERIMENTAL", "description": "Participants receive investigational MOTS-c plus standardized lifestyle counseling.", "interventionNames": [ "Drug: MOTS-c (MDP)", "Other: Route Subcutaneous injection", "Other: Regimen" ] }, { "label": "Placebo", "type": "PLACEBO_COMPARATOR", "description": "Participants receive matching placebo plus standardized lifestyle counseling.", "interventionNames": [ "Drug: Placebo", "Other: Route Subcutaneous injection", "Other: Regimen" ] } ], "primaryOutcomes": [ { "measure": "Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index)", "timeFrame": "12 Weeks" }, { "measure": "Incidence of treatment-emergent adverse events (TEAEs)", "timeFrame": "16 weeks" } ], "resultsFirstPosted": null, "conditions": [ "Prediabetes", "Insulin Resistance", "Overweight/Obesity" ], "interventions": [ { "type": "DRUG", "name": "MOTS-c (MDP)" }, { "type": "DRUG", "name": "Placebo" }, { "type": "OTHER", "name": "Route Subcutaneous injection" }, { "type": "OTHER", "name": "Regimen" } ], "briefSummary": "This Phase 2a study evaluates whether 12 weeks of treatment with investigational MOTS-c improves insulin sensitivity compared with placebo in adults with prediabetes and overweight/obesity.\n\nParticipants are randomized 1:1 to MOTS-c or placebo, receive standardized lifestyle counseling, and are followed for safety through Week 16.", "detailedDescription": "Mitochondrial-derived peptides (MDPs) are small peptides encoded by mitochondrial DNA that can act as signaling molecules. MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c) has been reported to regulate insulin sensitivity and metabolic homeostasis in preclinical studies, with skeletal muscle identified as a key target tissue and AMPK activation proposed as a downstream mechanism. Based on these findings, this trial is designed to test the hypothesis that MOTS-c can improve insulin sensitivity and cardiometabolic risk markers in humans with early metabolic dysfunction. The study includes a screening period (up to 4 weeks), a 12-week double-blind treatment period, and a 4-week post-treatment safety follow-up. Efficacy is assessed using a 75 g oral glucose tolerance test (OGTT)-derived insulin sensitivity index and standard metabolic endpoints (HbA1c, fasting glucose, lipids, body weight, and waist circumference). Safety assessments include adverse events, vital signs, ECG, and laboratory testing.", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT07505745", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07505745" }, { "id": "NCT07638696", "title": "Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding", "officialTitle": "Mitophagic Flux and Mitochondrial DNA Dynamics During Circadian-Aligned Ramadan Dry Fasting Versus 16:8 Time-Restricted Feeding: A Four-Phase Translational Research Programme", "protocolId": "Bahcesehir Cyprus University", "sponsor": "Bahcesehir Cyprus University", "status": "NOT_YET_RECRUITING", "statusVerified": "2026-06", "firstPosted": "2026-06-10", "lastUpdatePosted": "2026-06-11", "start": { "date": "2027-01-15", "type": "ESTIMATED" }, "primaryCompletion": { "date": "2027-04-15", "type": "ESTIMATED" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 120, "type": "ESTIMATED" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "Arm A: Ramadan Dry Fasting", "description": "Participants observing complete, daily fluid and nutrient deprivation from dawn (Fajr) to sunset (Maghrib) for 30 consecutive days during Ramadan 2027", "interventionNames": [ "Behavioral: Ramadan Intermittent Dry Fasting (Sawm)" ] }, { "label": "Arm B: 16:8 Time-Restricted Feeding", "description": "Pairwise-matched control participants practicing a fluid-permitted, 16-hour daily fasting window observed concurrently during the same calendar period", "interventionNames": [ "Behavioral: 16:8 Time-Restricted Feeding (TRF)" ] } ], "primaryOutcomes": [ { "measure": "Between-arm difference in PINK1 and Parkin mitophagy gene expression", "description": "Relative expression levels of PINK1 and Parkin mRNA will be quantified via probe-based quantitative reverse transcription PCR (qRT-PCR) from isolated peripheral blood mononuclear cells (PBMCs). Normalization will be performed using the geometric mean of housekeeping genes GAPDH and B2M. Evaluation will focus on the between-arm contrast (Arm A vs. Arm B) of the change metric using relative quantification (2\\^-ΔΔCt).", "timeFrame": "Change from baseline (Day -3) to Day 30 of the fasting period" }, { "measure": "Between-arm difference in mitochondrial DNA copy number (mtCN)", "description": "Mitochondrial DNA copy number will be quantified by qPCR targeting the mitochondrial reference region MT-RNR1 (12S rRNA), normalized to the nuclear reference gene B2M. Relative mtCN is calculated using the formula: 2 × (Ct\\_nuclear - Ct\\_mtDNA). The primary evaluation is the between-arm difference in net change at Day 30 to test for a predicted U-shaped cellular trajectory", "timeFrame": "Change from baseline (Day -3) to Day 30 of the fasting period" } ], "resultsFirstPosted": null, "conditions": [ "Mitochondrial Degradation", "Autophagy", "Fasting", "Healthy Volunteers", "Metabolic Adaptation" ], "interventions": [ { "type": "BEHAVIORAL", "name": "Ramadan Intermittent Dry Fasting (Sawm)" }, { "type": "BEHAVIORAL", "name": "16:8 Time-Restricted Feeding (TRF)" } ], "briefSummary": "This study investigates how different types of fasting affect cell health, specifically focusing on how mitochondria (the energy-producing parts of cells) are cleared and renewed. While standard intermittent fasting allows water intake, Ramadan dry fasting involves total restriction of both food and fluids from dawn to sunset.\n\nResearchers want to see if the combined effects of fluid restriction and natural daily body rhythms during Ramadan trigger a stronger cellular cleanup process (called mitophagy) compared to standard 16:8 water-permitted fasting. The study will look at how these fasting habits change blood markers related to mitochondrial DNA and metabolic health across a 30-day period. This research will help determine if dry fasting offers distinct biological benefits for cellular renewal.", "detailedDescription": "This is a prospective, single-centre, parallel-group, longitudinal observational cohort study conducted across Ramadan 2027. The study aims to evaluate the distinct molecular and metabolic trajectories of intermittent dry fasting compared to standard fluid-permitted time-restricted feeding (TRF).\n\nParticipants will be allocated to one of two parallel groups based on their self-selected, established fasting practices:\n\n* Group A (Ramadan Dry Fasting): Observing complete fluid and nutrient deprivation from dawn (Fajr) to sunset (Maghrib) for 30 consecutive days.\n* Group B (16:8 TRF): Practicing a 16-hour daily fasting window with water/fluids permitted, observed concurrently during the same calendar period.\n\nParticipants in both groups will be pairwise-matched based on age and BMI at screening. Blood samples will be collected from all participants at five distinct milestones:\n\n* T0: Pre-Ramadan baseline (Day -3)\n* T1: Acute induction phase (Day 7)\n* T2: Mitochondrial turnover phase (Day 14)\n* T3: Saturation plateau / primary endpoint (Day 30)\n* T4: Post-Ramadan recovery phase (Day 44)\n\nPeripheral blood mononuclear cells (PBMCs) and serum will be isolated from the collected blood. Laboratory analyses will measure mitochondrial DNA (mtDNA) copy number changes via qPCR, alongside a quantitative gene expression panel evaluating key regulators of mitophagy (such as PINK1 and Parkin), mitochondrial biogenesis, and general autophagy. Secondary evaluations include routine serum metabolic indicators, inflammatory markers, and dietary monitoring to evaluate the physiological pathways predicted by computational systems pharmacology.", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT07638696", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07638696" }, { "id": "NCT07678073", "title": "Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation", "officialTitle": "Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation: A Prospective Controlled Study", "protocolId": "2024/420", "sponsor": "University of Gaziantep", "status": "RECRUITING", "statusVerified": "2026-07", "firstPosted": "2026-07-01", "lastUpdatePosted": "2026-07-08", "start": { "date": "2026-03-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2026-10-01", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 68, "type": "ESTIMATED" }, "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "The study will use a parallel assignment interventional model. Participants will be assigned to one of two study groups: sevoflurane general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). Outcomes will be compared between the two groups to evaluate the effect of anesthetic technique on perioperative biomarker levels and clinical outcomes.", "primaryPurpose": "BASIC_SCIENCE", "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Laboratory personnel performing sample processing and biomarker analysis will be blinded to group allocation.", "whoMasked": [ "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "Sevoflurane General Anesthesia (SGA)", "type": "ACTIVE_COMPARATOR", "description": "Participants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation.", "interventionNames": [ "Drug: Sevoflurane General Anesthesia" ] }, { "label": "Combined Spinal-Epidural Anesthesia (CSEA)", "type": "ACTIVE_COMPARATOR", "description": "Participants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation.", "interventionNames": [ "Drug: Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia" ] } ], "primaryOutcomes": [ { "measure": "Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c)", "description": "The primary outcome is the perioperative change in serum levels of ferroptosis-related biomarkers and mitochondrial-derived peptides, including humanin and MOTS-c, between two standardized time points. Blood samples will be collected immediately prior to anesthesia induction and immediately prior to extubation. Biomarker levels will be quantified using ELISA-based and standard biochemical methods. The primary comparison will evaluate differences in biomarker changes between the sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) groups.", "timeFrame": "Immediately before anesthesia induction and immediately before extubation (intraoperative period)" } ], "resultsFirstPosted": null, "conditions": [ "Kidney Disease, End-Stage", "Kidney Transplant", "Kidney", "Kidney Disease", "Renal Transplant" ], "interventions": [ { "type": "DRUG", "name": "Sevoflurane General Anesthesia" }, { "type": "DRUG", "name": "Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia" } ], "briefSummary": "Renal transplantation is the most effective renal replacement therapy for patients with end-stage renal disease. Ischemia-reperfusion injury may adversely affect graft function and long-term outcomes. Ferroptosis has recently emerged as a potential mechanism involved in ischemia-reperfusion injury, while the mitochondrial-derived peptides humanin and MOTS-c are thought to exert protective effects against oxidative stress. However, the effects of different anesthetic techniques on these biomarkers in kidney transplant recipients have not been investigated.\n\nThis prospective controlled study aims to compare the effects of sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) on serum ferroptosis markers, humanin, and MOTS-c levels in adult kidney transplant recipients. Blood samples will be obtained perioperatively for biomarker analysis.\n\nThe primary objective of the study is to evaluate the effects of the anesthetic technique on serum ferroptosis markers, humanin, and MOTS-c levels. Secondary objectives include evaluating early graft function and postoperative outcomes by assessing the incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, length of hospital stay, and the association of these outcomes with perioperative biomarker levels.", "detailedDescription": "Renal transplantation represents the most effective form of renal replacement therapy for patients with end-stage renal disease; however, ischemia-reperfusion injury remains a major determinant of early graft dysfunction and long-term transplant outcomes.\n\nFerroptosis, an iron-dependent form of regulated cell death characterized by lipid peroxidation, has recently been proposed as an important mechanism contributing to ischemia-reperfusion-related tissue injury. In addition, mitochondrial-derived peptides such as humanin and MOTS-c have been identified as key regulators of cellular stress responses and may exert protective effects against oxidative damage. Despite these emerging findings, the influence of anesthetic technique on ferroptosis-related pathways and mitochondrial protective peptides in kidney transplantation has not yet been fully elucidated.\n\nThis prospective controlled study is designed to evaluate the effect of anesthetic technique on perioperative biochemical and clinical outcomes in renal transplant recipients. Adult patients undergoing kidney transplantation will receive either sevoflurane-based general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). The two anesthetic strategies will be compared in terms of their effects on circulating ferroptosis-related biomarkers, as well as serum levels of humanin and MOTS-c.\n\nPeripheral arterial blood samples will be obtained at two standardized points: immediately before anesthesia induction (T1) and immediately prior to extubation (T2). Following collection, blood samples will be centrifuged, and serum aliquots will be stored under appropriate conditions at -80°C until batch analysis. Serum levels of ferroptosis-related biomarkers, humanin, and MOTS-c will be measured using enzyme-linked immunosorbent assay (ELISA) and standard biochemical techniques.\n\nThe primary objective of the study is to assess the effect of anesthetic technique on perioperative changes in serum ferroptosis-related biomarkers and mitochondrial-derived peptides (humanin and MOTS-c).\n\nThe secondary objectives are to evaluate early postoperative graft function and clinical recovery parameters, including incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, and length of hospital stay. In addition, the association between perioperative biomarker levels and clinical outcomes will be analyzed to explore potential predictive relationships.\n\nIt is anticipated that this study will provide further insight into the relationship between anesthetic technique, ferroptosis pathways, and mitochondrial-mediated cytoprotection in renal transplantation. The results may contribute to improved understanding of perioperative biological responses and support optimization of anesthetic strategies aimed at enhancing graft outcomes.", "hasResults": false, "matchedQueries": [ "\"MOTS-c\"" ], "url": "https://clinicaltrials.gov/study/NCT07678073", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07678073" }, { "id": "NCT07706361", "title": "Two-Part Study of the Effects of the X39 Patch on Circulating GHK and GHK-Cu Levels in Healthy Adults", "officialTitle": "A Two-part Study Investigating the Effect of the X39 Patch on Circulating Blood Levels of GHK and GHK-Cu in a Healthy Adult Population", "protocolId": "26LWCRL04", "sponsor": "LifeWave, Inc.", "status": "NOT_YET_RECRUITING", "statusVerified": "2026-07", "firstPosted": "2026-07-15", "lastUpdatePosted": "2026-07-15", "start": { "date": "2027-01", "type": "ESTIMATED" }, "primaryCompletion": { "date": "2027-04", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 100, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Part 1: Single-arm, open-label \\& Part 2: Randomized, double-blind, placebo controlled, parallel", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "Part 1: Single-arm, open-label \\& Part 2: Randomized, double-blind, placebo controlled, parallel", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "X39 Patch", "type": "EXPERIMENTAL", "description": "Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed.", "interventionNames": [ "Device: X39 Patch" ] }, { "label": "Placebo patch", "type": "PLACEBO_COMPARATOR", "description": "Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed.", "interventionNames": [ "Device: Placebo Patch" ] } ], "primaryOutcomes": [ { "measure": "Change in GHK levels from baseline to Day 8", "description": "Part 1. Change in GHK levels from baseline to Day 8", "timeFrame": "Baseline (Day 0) to Day 8" }, { "measure": "Change in GHK levels from baseline to Day 8 between the X39 patch and placebo", "description": "Part 2. Change in GHK levels from baseline to Day 8 between the X39 patch and placebo", "timeFrame": "Baseline (Day 0) to Day 8" }, { "measure": "Change in GHK-Cu levels from baseline to Day 8", "description": "Part 1. Change in GHK-Cu levels from baseline to Day 8", "timeFrame": "Baseline (Day 0) to Day 8" }, { "measure": "Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo", "description": "Part 2. Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo", "timeFrame": "Baseline (Day 0) to Day 8" } ], "resultsFirstPosted": null, "conditions": [ "GHK and GHK-Cu Blood Levels" ], "interventions": [ { "type": "DEVICE", "name": "X39 Patch" }, { "type": "DEVICE", "name": "Placebo Patch" } ], "briefSummary": "The goal of this clinical trial is to investigate GHK and GHK-Cu blood levels pre- and post-intervention in healthy adults, and to investigate the efficacy of X39 patch on GHK and GHK-Cu blood levels in healthy adults compared to a placebo. The main questions it aims to answer are:\n\n* What is the change in GHK and GHK-Cu levels from baseline to Day 8?\n* What is the difference in the change in GHK and GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo? Researchers will compare X39 patches to placebo patches to evaluate their effects on circulating blood levels of GHK and GHK-Cu in healthy adults.\n\nParticipants will be asked to complete a questionnaire and use the X39 patch or placebo patch.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"GHK-Cu\" OR \"GHK Cu\"" ], "url": "https://clinicaltrials.gov/study/NCT07706361", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07706361" }, { "id": "NCT07717866", "title": "Trifecta Research Study", "officialTitle": "Trifecta Research Study - An Observational Study Evaluating the Impact of Ibogaine-Magnesium, 5-MeO-DMT, Magnetic e-Resonance Therapy, and Physiological Supplementation in Special Operations Forces Combat Veterans", "protocolId": "65357", "sponsor": "Axial Therapeutic Research", "status": "ACTIVE_NOT_RECRUITING", "statusVerified": "2026-07", "firstPosted": "2026-07-21", "lastUpdatePosted": "2026-07-21", "start": { "date": "2022-08-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2026-02-01", "type": "ACTUAL" }, "studyType": "OBSERVATIONAL", "phases": [], "enrollment": { "count": 52, "type": "ACTUAL" }, "designInfo": { "observationalModel": "COHORT", "timePerspective": "PROSPECTIVE" }, "arms": [ { "label": "Intervention Sequence 1", "description": "Individuals in this arm will undergo Physiological Supplementation, then Ibogaine and 5-MeO treatment, and then MeRT therapy.", "interventionNames": [ "Device: Magnetic e-Resonance Therapy (MeRT)", "Drug: Ibogaine Hydrochloride with Magnesium Sulfate", "Drug: 5-methoxy-N,N-dimethyltryptamine", "Drug: Physiological Supplementation" ] }, { "label": "Intervention Sequence 2", "description": "Individuals in this arm will undergo Physiological Supplementation, then MeRT therapy, and then Ibogaine and 5-MeO-DMT.", "interventionNames": [ "Device: Magnetic e-Resonance Therapy (MeRT)", "Drug: Ibogaine Hydrochloride with Magnesium Sulfate", "Drug: 5-methoxy-N,N-dimethyltryptamine", "Drug: Physiological Supplementation" ] } ], "primaryOutcomes": [ { "measure": "PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5)", "description": "The PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire designed to assess the severity of PTSD symptoms in alignment with the DSM-5 diagnostic criteria. A total symptom severity score (range - 0-80) will be obtained by summing the scores for each of the 20 items with higher scores indicating greater symptom severity. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3 month follow up (MFU), 6MFU, 12MFU.", "timeFrame": "Up to 12 months follow up" }, { "measure": "Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)", "description": "The Medical Outcomes Study - Cognitive Functioning (MOS-CF) self-report scale consists of 6 items that are designed to measure perceived cognitive functioning. Each item is scored on a 6-point scale (1-6), with 1 being 'all of the time' and 6 being 'none of the time.' Higher scores indicate higher cognitive functioning and lower cognitive symptoms. Collected - Group/Sequence 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group/Sequence 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU", "timeFrame": "Up to 12 months follow up" }, { "measure": "Stroop Squared Task", "description": "In the Stroop Squared Task, participants will select words corresponding to the color of the stimulus word given. For example, participants will name the color of the ink a word is printed in while ignoring the word itself (e.g., the word \"BLUE\" printed in red ink). The task primarily measures cognitive inhibition. Each participant will receive one score indexing the delay in reaction time caused by the mismatch between word and color.\n\nData Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3MFU, 6MFU, 12MFU.", "timeFrame": "Up to 12 months follow-up" }, { "measure": "Externalized Free Recall with Emotional Words Task", "description": "In the Externalized Free Recall with Emotional Words Task, participants will be presented with a series of emotionally positive, negative, and neutral stimuli (e.g., words or images) and asked to recall the stimuli. The task captures how well individuals retain and recall emotional versus neutral content. Dependent variables include:\n\nV1. The proportion of total words correctly recalled of total words administered V1.1. The proportion of recalled negative words of all words recalled V1.2. The proportion of recalled positive words of all words recalled V1.3. The proportion of recalled neutral words of all words recalled V2. The absolute number of total recall intrusions V2.1. The proportion of intruding negative words of all intruding words V2.2. The proportion of intruding positive words of all intruding words V2.3. The proportion of intruding neutral words of all intruding words Data Collected: Group/Sequence A: pre-PS, Post-MeRT; Group/Sequence B: pre-PS, post-IM/5Meo.", "timeFrame": "Up to 15 weeks (Post-MeRT for Group A, Post-IM/5MeO for Group B)" } ], "resultsFirstPosted": null, "conditions": [ "PTSD - Post Traumatic Stress Disorder", "Cognitive Dysfunction", "Brain Injury", "Depression - Major Depressive Disorder", "Suicidal Ideation" ], "interventions": [ { "type": "DEVICE", "name": "Magnetic e-Resonance Therapy (MeRT)" }, { "type": "DRUG", "name": "Ibogaine Hydrochloride with Magnesium Sulfate" }, { "type": "DRUG", "name": "5-methoxy-N,N-dimethyltryptamine" }, { "type": "DRUG", "name": "Physiological Supplementation" } ], "briefSummary": "This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations Forces (SOF) combat veterans.", "detailedDescription": "Approximately forty participants took part in a program of experimental interventions and therapies that was created to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions. Participants were obtained from a cohort of SOF veterans who were already seeking these therapies through the Special Operations Care-Fund (SOC-F) and chose to volunteer for the study. Participants were assigned by SOC-F to one of two sequences of interventions through SOC-F's care providers. One group received PS, then MeRT, then IM and 5-MeO-DMT. The other group received PS, then IM and 5-MeO-DMT, then MeRT. PS preceded the other interventions in each condition. The study design includes self-report and informant-report questionnaires and cognitive task assessments, all of which monitor the interventions' impact on health outcomes. The general purpose is to explore the potential for this combination of treatments to improve mental health and cognitive function. A collection of subjective and objective data will allow a comprehensive assessment of therapeutic impact, with the ultimate goal of informing future clinical trials and veteran treatment services. This project was formerly registered on clinicaltrials.gov (NCT06810765).\n\nAims and Hypotheses:\n\nAim 1: Investigate the impact of all interventions on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties.\n\nH1.1. Collectively, program interventions will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (3MFU).\n\nH1.2. Collectively, program interventions will be associated with improved self-reported cognitive functioning at 3MFU.\n\nH1.3. Collectively, program interventions will be associated with improved cognitive inhibition, indexed by the Stroop Squared Task, at Post-treatment.\n\nH1.4. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of recalled positive words (see V1.1 in Dependent Variable section) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.\n\nH1.5. Collectively, program interventions will be associated with improved positive emotional memory, indexed by a higher proportion of recalled positive words (V1.2) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.\n\nH1.6. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of negative recall intrusions (V2.1) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment.\n\nAim 2: Investigate the incremental impact of IM and 5-Meo-DMT on PTSD symptoms and cognitive functioning relative to initial intervention with PS and MeRT in SOF veterans with PTSD and cognitive difficulties.\n\nH2.1. IM/5-Meo-DMT will be associated with an incremental reduction in self-reported PTSD symptoms at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).\n\nH2.2. IM/5-Meo-DMT will be associated with an incremental improvement in self-reported cognitive functioning at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).\n\nH2.3. IM/5-Meo-DMT will be associated with an incremental improvement in cognitive inhibition at Post-treatment, indexed by the Stroop Squared Task, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint).\n\nAim 3: Investigate whether the sequence of interventions differentially impacts PTSD and cognitive functioning at 3MFU in SOF veterans. No formal hypotheses.\n\nAim 4: Investigate adverse events related to each of the interventions. No formal hypotheses.", "hasResults": false, "matchedQueries": [ "\"Ipamorelin\"" ], "url": "https://clinicaltrials.gov/study/NCT07717866", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07717866" }, { "id": "NCT07752381", "title": "A Clinical Trial to Evaluate the Effects of Peptide Gummies on Markers of Inflammation, Physical Performance, and Recovery", "officialTitle": "A Clinical Trial to Evaluate the Effects of Peptide Gummies on Markers of Inflammation, Physical Performance, and Recovery", "protocolId": "20819", "sponsor": "Parlay Wellness", "status": "COMPLETED", "statusVerified": "2026-08", "firstPosted": "2026-08-07", "lastUpdatePosted": "2026-08-07", "start": { "date": "2025-09-01", "type": "ACTUAL" }, "primaryCompletion": { "date": "2025-11-01", "type": "ACTUAL" }, "studyType": "INTERVENTIONAL", "phases": [ "NA" ], "enrollment": { "count": 40, "type": "ACTUAL" }, "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "Parlay Recover Peptide Gummies", "type": "EXPERIMENTAL", "interventionNames": [ "Dietary Supplement: Parlay Recover Peptide Gummies" ] } ], "primaryOutcomes": [ { "measure": "Change in High-Sensitivity C-Reactive Protein (hs-CRP)", "description": "Change in serum hs-CRP levels as measured by blood testing at Quest Diagnostics Clinic", "timeFrame": "Baseline and Week 8" }, { "measure": "Change in Interleukin-6 (IL-6)", "description": "Change in serum IL-6 levels as measured by blood testing at Quest Diagnostics Clinic", "timeFrame": "Baseline and Week 8" }, { "measure": "Change in Self-Reported Swelling", "description": "Change in perceived swelling around muscles and joints as assessed by self-reported questionnaire", "timeFrame": "Baseline, Week 2, Week 4, Week 6, and Week 8" } ], "resultsFirstPosted": null, "conditions": [ "Musculoskeletal Inflammation", "Exercise-Induced Muscle Damage", "Post-Exercise Recovery", "Musculoskeletal Pain" ], "interventions": [ { "type": "DIETARY_SUPPLEMENT", "name": "Parlay Recover Peptide Gummies" } ], "briefSummary": "This study will evaluate the effects of Parlay Recover peptide gummies (containing Body Protection Compound BPC-157) on markers of inflammation, physical performance, and recovery in physically active adults. Over an 8-week period, 40 participants will consume two gummies daily and complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8, as well as undergo blood testing at Baseline and Week 8.\n\nThe primary objective is to examine changes in inflammatory biomarkers (hs-CRP and IL-6) as measured by blood testing. Secondary objectives include evaluating participants' self-reported perceptions of the product's effects on physical performance and recovery, including aching, stiffness, function, and recovery of muscles and joints.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"BPC-157\" OR \"BPC 157\"" ], "url": "https://clinicaltrials.gov/study/NCT07752381", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07752381" }, { "id": "NCT07803250", "title": "Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery", "officialTitle": "Impact of BPC-157 on Recovery From Rotator Cuff Repair Surgery", "protocolId": "298969", "sponsor": "University of Arkansas", "status": "NOT_YET_RECRUITING", "statusVerified": "2026-09", "firstPosted": "2026-09-03", "lastUpdatePosted": "2026-09-03", "start": { "date": "2027-01-01", "type": "ESTIMATED" }, "primaryCompletion": { "date": "2027-08-01", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1" ], "enrollment": { "count": 30, "type": "ESTIMATED" }, "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "QUADRUPLE", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] } }, "arms": [ { "label": "BPC-157 Group", "type": "EXPERIMENTAL", "description": "Participants in this arm will receive BPC-157. BPC-157 will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. All participants will follow the standard postoperative rehabilitation protocol in addition to the study intervention.", "interventionNames": [ "Drug: BPC-157" ] }, { "label": "Sham", "type": "SHAM_COMPARATOR", "description": "Participants in this arm will receive normal saline. Normal saline will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. All participants will follow the standard postoperative rehabilitation protocol in addition to the study intervention.", "interventionNames": [ "Other: Sham (No Treatment)" ] } ], "primaryOutcomes": [ { "measure": "Shoulder Strength", "description": "Isometric shoulder abduction strength will be assessed using a handheld dynamometer. Strength measurements will focus on shoulder abduction and external rotation at 0° abduction. Three trials will be recorded, and the average peak force will be used as the outcome value. Testing will be performed by a blinded evaluator using a standardized protocol.", "timeFrame": "Baseline, 12 weeks, and 5 months post operatively" } ], "resultsFirstPosted": null, "conditions": [ "Rotator Cuff Tear" ], "interventions": [ { "type": "DRUG", "name": "BPC-157" }, { "type": "OTHER", "name": "Sham (No Treatment)" } ], "briefSummary": "This study is a randomized, double-blind, placebo-controlled pilot trial investigating the effects of BPC-157 on tendon healing and functional recovery following arthroscopic rotator cuff repair (aRCR). BPC-157 is a synthetic peptide that has demonstrated promising regenerative and anti-inflammatory effects in preclinical animal models of musculoskeletal injury, but it has not yet been studied in formal human clinical trials.\n\nTwenty patients undergoing aRCR will be enrolled and randomly assigned to receive either BPC-157 or a saline placebo. Participants will self-administer subcutaneous injections daily for 90 days following surgery. All other aspects of care will follow the standard postoperative rehabilitation protocol.\n\nThe study will assess tendon healing using postoperative MRI, patient-reported outcome measures (PROMs), range of motion (ROM), and muscle strength via handheld dynamometry. Blood samples will also be collected to evaluate biomarkers associated with collagen turnover and inflammation.\n\nThe goal of this pilot study is to evaluate the safety, feasibility, and preliminary efficacy of BPC-157 in promoting tendon healing and improving functional outcomes after rotator cuff repair. Results will inform the design of a future larger-scale clinical trial.", "detailedDescription": "", "hasResults": false, "matchedQueries": [ "\"BPC-157\" OR \"BPC 157\"" ], "url": "https://clinicaltrials.gov/study/NCT07803250", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07803250" }, { "id": "NCT07888595", "title": "Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks", "officialTitle": "Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks", "protocolId": "FBS-PRS-2026", "sponsor": "Frontiers in Bioscience Research Institute and Aging", "status": "ENROLLING_BY_INVITATION", "statusVerified": "2026-10", "firstPosted": "2026-10-22", "lastUpdatePosted": "2026-10-22", "start": { "date": "2026-10-21", "type": "ESTIMATED" }, "primaryCompletion": { "date": "2028-10-14", "type": "ESTIMATED" }, "studyType": "INTERVENTIONAL", "phases": [ "EARLY_PHASE1" ], "enrollment": { "count": 48, "type": "ESTIMATED" }, "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "primaryPurpose": "TREATMENT", "maskingInfo": { "masking": "NONE" } }, "arms": [ { "label": "Geroprotective treatment", "type": "EXPERIMENTAL", "description": "Participants receive systemic geroprotective agents (metformin, low-dose chloroquine, ivermectin, or a defined nutritional supplement - collagen lysate, thymoquinone/black seed oil, urolithin) alone or in combination, and/or a topical geroprotective formulation. Blood and skin samples are analyzed by molecular means and amount of SASP (IL6/IL8) will be measured in serum compared with each participant's untreated reference sites and baseline.", "interventionNames": [ "Drug: Topical anti-aging peptide serum" ] } ], "primaryOutcomes": [ { "measure": "START/REST biological age (transcriptomic tAge and proteomic pAge), in years", "description": "Change from baseline in biological age from the START/REST clocks - transcriptomic age (tAge) by qPCR and proteomic age (pAge) by plasma protein ELISA panel - in treated tissue (skin, hair, saliva, and/or peripheral blood) versus each participant's untreated reference sites and baseline. Reported in years.", "timeFrame": "4 weeks" } ], "resultsFirstPosted": null, "conditions": [ "Aging" ], "interventions": [ { "type": "DRUG", "name": "Topical anti-aging peptide serum" } ], "briefSummary": "This study tests whether certain medicines and a skin treatment can slow down or partly reverse the body's aging process.\n\nAs people age, the activity of their genes changes in predictable ways. Researchers can now measure a person's \"biological age\" from these gene-activity patterns in skin and blood. This study uses that measurement to see whether treatment can lower a person's biological age compared with their own starting point.\n\nAdults in the study take geroprotective (\"age-protecting\") agents by mouth or by injection. A separate skin serum containing small anti-aging peptides is applied to certain areas of skin, and those treated areas are compared with untreated areas on the same person.\n\nSkin and blood samples are taken at set times to measure biological age and markers of cell aging before, during, and after treatment. The main goal is to find out whether treatment lowers measured biological age in skin and blood. The study also looks at whether the treatments are safe and well tolerated.", "detailedDescription": "This is a prospective, single-group interventional study with two treatment components, systemic and topical. Each participant contributes paired treated and untreated samples and serves as their own internal control, reducing inter-individual variability in clock measurements.\n\nSystemic component: participants receive geroprotective agents administered orally or subcutaneously. Candidate agents include metformin, low-dose chloroquine, ivermectin, and a defined nutritional supplement (collagen lysate; black seed oil or its active constituent thymoquinone; urolithin; and controlled pH modulation with citric, acetic, or glycolic acid), used alone or in combination per protocol.\n\nTopical component: an aqueous serum of small, water-soluble anti-aging peptides below the \\~500-Dalton stratum corneum penetration cutoff - GHK-Cu (\\~404 Da), AHK-Cu (\\~418 Da), Epitalon (\\~390 Da), PGP/Pro-Gly-Pro (\\~269 Da), and CLV/Cys-Leu-Val (\\~333 Da) - is applied at approximately 1-3 mg/mL to defined skin sites. Treated sites are compared with matched untreated contralateral, adjacent, or distant sites on the same participant.\n\nBlood, skin biopsies, exfoliated skin cells, plucked hair follicles, and saliva are used to assess treatment effect locally and systemically.\n\nObjectives Primary: determine whether treatment produces a statistically significant reduction in START/REST-derived transcriptomic biological age in skin, hair, saliva, and peripheral blood, relative to each participant's baseline and untreated reference tissue.\n\nSecondary: characterize changes in molecular markers of cellular senescence, inflammaging/SASP, transcriptional fitness, and metabolic cofactors; assess concordance between systemic and local rejuvenation signals; evaluate safety and tolerability of each agent across the treatment period.\n\nProcedures and Sampling Skin biopsies, exfoliated keratinocytes, plucked follicles, saliva, and blood are collected at scheduled baseline, on-treatment, and post-treatment timepoints for transcriptomic profiling and senescence-marker analysis.\n\nOutcome Definition Age-reversal is defined prospectively as a statistically significant decrease in clock-derived biological age in treated tissue relative to both baseline and untreated reference tissue.\n\nSignificance The study aims to provide the first transcriptional clock-anchored human evidence that combined systemic and topical geroprotection can drive coordinated rejuvenation across tissues.", "hasResults": false, "matchedQueries": [ "\"Epitalon\" OR \"Epithalon\"", "\"GHK-Cu\" OR \"GHK Cu\"" ], "url": "https://clinicaltrials.gov/study/NCT07888595", "sourceUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07888595" } ] }