[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hudson Biotech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":277},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,54,89,119,155,187,218,248],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100631827","phase-2-mots-c-for-improving-insulin-sensitivity-in-adults-with-prediabetes-and-overweightobesity-100631827",false,"NCT07505745","MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight\u002FObesity","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\u002FObesity","MOTS-MET","Inclusion Criteria:\n\n* Age 18 to 65 years at the time of consent.\n* Body mass index (BMI) 27.0 to 40.0 kg\u002Fm\\^2.\n* Prediabetes documented at screening by any of the following: (a) HbA1c 5.7% to 6.4%; (b) fasting plasma glucose 100 to 125 mg\u002FdL; or (c) 2-hour plasma glucose 140 to 199 mg\u002FdL during a 75 g OGTT.\n* Stable body weight (less than 5% change) for at least 3 months prior to screening.\n* Willingness to maintain stable diet and physical activity patterns during the 12-week treatment period.\n* For participants of childbearing potential: agreement to use highly effective contraception for the study duration and for a protocol-specified period after last dose.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Diabetes mellitus (e.g., HbA1c 6.5% or higher, fasting plasma glucose 126 mg\u002FdL or higher, or 2-hour glucose 200 mg\u002FdL or higher at screening).\n* Use of glucose-lowering medications (including metformin, GLP-1 receptor agonists, SGLT2 inhibitors) within 3 months prior to screening.\n* History of bariatric surgery or planned weight-loss surgery during the study period.\n* Clinically significant cardiovascular disease within 6 months (e.g., myocardial infarction, stroke, unstable angina) or uncontrolled hypertension.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2, clinically significant hepatic disease, or ALT\u002FAST \\> 2.5x upper limit of normal at screening.\n* Active malignancy requiring treatment (except adequately treated non-melanoma skin cancer).\n* Pregnant, breastfeeding, or planning pregnancy during the study period.\n* Known hypersensitivity to peptide therapeutics or any component of the investigational product formulation.\n* Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results (e.g., inability to comply with study procedures).","ALL","18 Years","65 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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\u002Fobesity.\n\nParticipants are randomized 1:1 to MOTS-c or placebo, receive standardized lifestyle counseling, and are followed for safety through Week 16.",[28,29,30],"Prediabetes","Insulin Resistance","Overweight\u002FObesity",[32,33,34,35,36,37,38,39,40],"MOTS-c","mitochondrial-derived peptide","MDP","insulin sensitivity","AMPK","prediabetes","metabolic syndrome","OGTT","HbA1c","RECRUITING","2026-03-26",{"date":44,"type":45},"2026-04-01","ACTUAL",{"date":47,"type":45},"2026-02-02",{"date":49,"type":22},"2028-05-17",{"name":51,"class":52},"Hudson Biotech","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":53},"100630414","phase-1-tb-500-thymosin-beta-4-17-23-fragment-for-cardiovascular-biomarkers-in-stable-ascvd-100630414","NCT07487363","TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD","A Phase 1\u002F2, 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","TBRIDGE-CV","Inclusion Criteria:\n\n* Age 40-75 years, able to provide written informed consent.\n* Documented stable ASCVD (e.g., prior myocardial infarction \\>6 months ago, prior coronary revascularization, stable angina with objective evidence of ischemia, or symptomatic peripheral artery disease).\n* On stable guideline-directed medical therapy (e.g., statin and antiplatelet therapy unless contraindicated) for at least 8 weeks before screening.\n* Resting systolic blood pressure \\\u003C160 mmHg and diastolic blood pressure \\\u003C100 mmHg (with or without therapy).\n* Able and willing to comply with study visits and procedures.\n\nExclusion Criteria:\n\n* Acute coronary syndrome, stroke\u002Ftransient ischemic attack, or coronary revascularization within 6 months before screening.\n* New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction \\\u003C35%.\n* Clinically significant arrhythmia requiring recent hospitalization or unstable antiarrhythmic therapy.\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2) or end-stage renal disease.\n* Clinically significant hepatic impairment (e.g., Child-Pugh class B\u002FC) or ALT\u002FAST \\>3x upper limit of normal at screening.\n* Active malignancy requiring systemic therapy (except adequately treated non-melanoma skin cancer) within the past 2 years.\n* Known autoimmune disease requiring systemic immunosuppression, or use of chronic systemic corticosteroids above physiologic replacement.\n* Pregnant or breastfeeding, or unwilling to use effective contraception during the study (if of childbearing potential).\n* Known hypersensitivity to peptide therapeutics or study formulation components.\n* Participation in another interventional clinical study or receipt of an investigational product within 30 days (or 5 half-lives, whichever is longer) prior to screening.","40 Years","75 Years",{"count":65,"type":22},80,[67,25],"PHASE1","This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1\u002F2 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",[70,71],"Atherosclerotic Cardiovascular Diseases","Endothelial Dysfunction",[73,74,75,76,77,78,79,80],"TB-500","thymosin beta 4 fragment","vascular repair","endothelial function","flow-mediated dilation","inflammation","hs-CRP","atherosclerosis","2026-03-17",{"date":83,"type":45},"2026-03-23",{"date":85,"type":45},"2026-02-05",{"date":87,"type":22},"2028-02-17",{"name":51,"class":52},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":118,"locationsCount":53},"100629981","phase-2-tesamorelin-for-reduction-of-liver-fat-in-adults-with-fatty-liver-disease-mock-study-100629981","NCT07481734","Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)","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)","TESA-LIVER","Inclusion Criteria:\n\n* Adults age 18 to 75 years, able to provide informed consent.\n* Evidence of hepatic steatosis consistent with MASLD\u002FNAFLD, defined as MRI-PDFF \\>=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks).\n* Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension).\n* Stable body weight (+\u002F-5%) for at least 3 months prior to screening.\n* If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52.\n* Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver).\n* For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline.\n\nExclusion Criteria:\n\n* Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., \\>20 g\u002Fday for women or \\>30 g\u002Fday for men for sustained periods).\n* Other chronic liver diseases (e.g., chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency).\n* Known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed.\n* Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active\u002Funtreated diabetic retinopathy).\n* Use of exogenous growth hormone or GHRH analogs within the past 12 months.\n* Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).\n* Active malignancy or high risk for recurrence judged unsafe by investigators.\n* Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required.\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol).\n* Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.",{"count":21,"type":22},[25],"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.",[101,102,103],"Metabolic Associated Steatotic Liver Disease","Nonalcoholic Steatohepatitis","Hepatic Steatosis",[105,106,107,108,109,110,111,112],"Tesamorelin","GHRH analog","growth hormone axis","hepatic fat fraction","MRI-PDFF","transient elastography","teatohepatitis","fibrosis","2026-03-14",{"date":115,"type":45},"2026-03-19",{"date":47,"type":45},{"date":87,"type":22},{"name":51,"class":52},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":53},"100629982","phase-3-efficacy-and-safety-of-tirzepatide-once-weekly-versus-placebo-in-participants-who-are-either-obese-or-overweight-with-weight-related-comorbidities-surmount-1-100629982","NCT07481747","Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)","Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)","SURMOUNT-1","Inclusion Criteria:\n\n* BMI ≥30 kg\u002Fm², OR BMI ≥27 kg\u002Fm² with ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)\n* History of at least one unsuccessful dietary effort to lose weight (self-reported)\n* Investigator judges participant capable and willing to self-inject (or have assistance), follow lifestyle advice, maintain a diary, and complete questionnaires\n* Age ≥18 years\n* Meets protocol contraception\u002Fpregnancy criteria (as applicable) and provides written informed consent\n\nExclusion Criteria:\n\n* Type 1 or type 2 diabetes, history of ketoacidosis\u002Fhyperosmolar state, or screening labs diagnostic of diabetes\n* Recent significant weight change (\\>5 kg within 3 months prior to screening)\n* Prior\u002Fplanned bariatric surgery; recent\u002Fongoing endoscopic or device-based obesity therapies\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Clinically significant gastric emptying abnormality or chronic use of drugs that directly affect GI motility\n* History of chronic or acute pancreatitis\n* Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study\n* Obesity due to other endocrinologic disorders (e.g., Cushing syndrome) or monogenic\u002Fsyndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome)\n* Significant unstable major depressive disorder\u002Fsevere psychiatric disorder, lifetime suicide attempt, or concerning suicidality screening (PHQ-9\u002FC-SSRS criteria)\n* Uncontrolled hypertension; recent major cardiovascular events; NYHA class IV heart failure\n* Active or significant liver disease or certain elevated liver tests at screening (per protocol thresholds)\n* Elevated calcitonin above protocol thresholds; personal\u002Ffamily history of medullary thyroid carcinoma or MEN2\n* Active\u002Funtreated malignancy or remission \\\u003C5 years (with specified exceptions)\n* Any other condition contraindicating GLP-1 receptor agonist therapy",{"count":128,"type":22},2539,[130],"PHASE3","This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with prediabetes at randomization may continue in an additional long-term treatment period to assess progression to type 2 diabetes and longer-term weight outcomes.",[133,134],"Obesity","Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities",[136,137,138,139,140,141,142,143,144,145,146,147,148,149],"Tirzepatide","LY3298176","dual incretin","GIP","GLP-1","obesity","overweight","weight management","placebo","randomized","double-blind","once-weekly","subcutaneous","lifestyle intervention",{"date":115,"type":45},{"date":47,"type":45},{"date":153,"type":22},"2028-03-17",{"name":51,"class":52},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":186,"locationsCount":53},"100628884","phase-2-effect-of-ly3437943-versus-placebo-in-participants-who-have-obesity-or-are-overweight-100628884","NCT07467447","Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight","A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities","GZBF","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive) at time of informed consent.\n* BMI ≥30 and ≤50 kg\u002Fm², OR BMI ≥27 and \\\u003C30 kg\u002Fm² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure).\n* Motivated and able\u002Fwilling to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires.\n* Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum).\n* Male and\u002For female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding.\n* Capable of giving signed informed consent and complying with protocol requirements.\n\nExclusion Criteria:\n\n* History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state\u002Fcoma.\n* Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg\u002FdL; or random glucose ≥200 mg\u002FdL).\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening.\n* Prior or planned surgical treatment for obesity (exceptions: liposuction\u002Fabdominoplasty \\>1 year prior).\n* Current\u002Fplanned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization).\n* Renal impairment: eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m² (CKD-EPI) at screening.\n* Clinically significant gastric emptying abnormality (e.g., severe gastroparesis) or chronic drugs affecting GI motility.\n* History of acute or chronic pancreatitis (exception for resolved gallstone pancreatitis post-cholecystectomy).\n* TSH outside 0.4 to 6.0 mIU\u002FL at screening (with protocol-defined exceptions).\n* Obesity due to other endocrine disorders (e.g., Cushing's) or monogenic\u002Fsyndromic obesity (e.g., Prader-Willi).\n* Psychiatric exclusion criteria including unstable major depressive disorder\u002Fsevere psychiatric disorder within 2 years; lifetime suicide attempt; PHQ-9 score ≥15; or specified Columbia-Suicide Severity Rating Scale (C-SSRS) findings within past month.\n* Uncontrolled hypertension (systolic ≥160 mmHg and\u002For diastolic ≥100 mmHg) or elevated resting pulse rate (\\>100 bpm) at baseline.\n* Recent (within 3 months) major cardiovascular events (e.g., MI, stroke, unstable angina, CHF hospitalization); tachyarrhythmia syndromes; NYHA Class III-IV CHF; or ECG abnormalities interfering with interpretation.\n* Acute\u002Fchronic hepatitis or liver disease other than NAFLD; or screening labs: ALT \\>3× ULN, ALP \\>1.5× ULN, or total bilirubin \\>1.5× ULN (with exception).\n* Elevated calcitonin at Visit 1 per protocol thresholds; personal\u002Ffamily history of medullary thyroid carcinoma or MEN2.\n* Active\u002Funtreated malignancy or remission \\\u003C5 years (with protocol exceptions for certain in-situ\u002Fskin cancers).\n* Contraindication to GLP-1 receptor agonists, or other conditions that could prevent protocol compliance (including drug\u002Falcohol abuse or eating disorder), per investigator judgment.\n* Alcohol consumption \\>14 units\u002Fweek (women) or \\>21 units\u002Fweek (men).\n* Recent marijuana\u002FTHC-containing product use within 3 months or unwillingness to abstain during trial (protocol exception for cannabidiol oil if agrees to refrain).\n* Organ transplant history (except corneal transplant) or awaiting transplant.\n* Hematologic conditions interfering with HbA1c measurement; recent large blood donation\u002Ftransfusion\u002Fsevere blood loss; hemoglobin below protocol thresholds.\n* Severe atopy\u002Fmultiple severe allergies or severe hypersensitivity reactions.\n* Fasting triglycerides \\>500 mg\u002FdL at screening (with stability requirement for lipid-lowering therapy).\n* Significant active, uncontrolled medical condition or history posing risk or interfering with data interpretation, per investigator judgment.\n* History of symptomatic gallbladder disease within past 2 years (protocol-defined exceptions after cholecystectomy).\n* History of documented HIV infection.\n* Chronic systemic glucocorticoid therapy within 3 months or active autoimmune abnormality likely to require systemic steroids during study (with specified formulation exceptions).\n* Recent medications that may cause significant weight gain (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers) within 3 months.\n* Recent use (within 3 months) of medications or remedies intended to promote weight loss (examples listed in protocol, including GLP-1 RAs).\n* Use of metformin or other glucose-lowering medications (e.g., for PCOS or diabetes prevention) not permitted at entry.\n* Started implantable\u002Finjectable contraceptives within 18 months prior to screening (IUDs allowed if used ≥3 months).\n* Known allergies to GLP-1 receptor agonists or LY3437943.\n* Currently enrolled in another investigational study or recent participation\u002Ftreatment within 30 days (or 5 half-lives, whichever longer).\n* Previously received LY3437943 in this or another study.\n* Investigator site personnel directly affiliated with the study and\u002For their immediate family; or Lilly employees.\n* Note: The publicly posted protocol references additional exclusion criteria numbered 52-57 in a separate protocol addendum (not included in the posted protocol PDF).",{"count":164,"type":22},300,[25],"Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.",[133],[169,170,171,172,173,174,175,176,177,178,179],"Retatrutide","LY3437943","triple agonist","GIP receptor agonist","GLP-1 receptor agonist","glucagon receptor agonist","weight loss","body weight","BMI","waist circumference","lifestyle counseling","2026-03-08",{"date":182,"type":45},"2026-03-12",{"date":184,"type":45},"2026-02-15",{"date":87,"type":22},{"name":51,"class":52},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":195,"sex":17,"minAge":18,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":216,"leadSponsor":217,"locationsCount":53},"100626588","phase-2-topical-ghk-cu-gel-for-acute-skin-wound-healing-100626588","NCT07437586","Topical GHK-Cu Gel for Acute Skin Wound Healing","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","CuHeal","Inclusion Criteria:\n\n* Age 18 to 55 years at screening.\n* Healthy adult as determined by medical history and limited physical examination.\n* Body mass index (BMI) 18.0 to 30.0 kg\u002Fm².\n* Willing and able to comply with study visits and daily product application for 14 days.\n* Willing to avoid applying non-study topical products (including medicated creams, retinoids, acids) to the wound area during the study period.\n* For participants of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception through Day 21.\n\nExclusion Criteria:\n\n* Known allergy or sensitivity to copper, peptides, gel excipients, adhesives, or dressings used in the study.\n* History of abnormal wound healing, hypertrophic scarring, or keloid formation.\n* Clinically significant dermatologic disease near the intended wound site (e.g., eczema, psoriasis, active infection).\n* Diabetes mellitus, peripheral vascular disease, immunodeficiency, or other condition that may impair wound healing (investigator judgment).\n* Use of systemic corticosteroids, immunosuppressants, or cytotoxic medications within 30 days prior to Day 0.\n* Current smoker or nicotine use (including vaping) within the past 3 months.\n* Pregnant or breastfeeding.\n* Participation in another interventional clinical study within 30 days prior to screening.\n* Any condition that, in the investigator's opinion, would make participation unsafe or could interfere with study assessments.",true,"55 Years",{"count":198,"type":22},60,[25],"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.",[202],"Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)",[204,205,206,207,208,209,210,211],"GHK-Cu","copper peptide","Copper(II)-peptide complex","copper tripeptide-1","wound healing","re-epithelialization","skin repair","scar quality","2026-02-22",{"date":214,"type":45},"2026-02-27",{"date":47,"type":45},{"date":153,"type":22},{"name":51,"class":52},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":246,"leadSponsor":247,"locationsCount":53},"100626585","phase-2-bpc-157-for-acute-hamstring-muscle-strain-repair-100626585","NCT07437547","BPC 157 for Acute Hamstring Muscle Strain Repair","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","BPC-HAMSTR","Inclusion Criteria:\n\n* Age 18 to 45 years.\n* Acute posterior thigh pain consistent with hamstring strain with onset within 72 hours prior to screening.\n* MRI-confirmed grade II hamstring strain of the biceps femoris, semitendinosus, or semimembranosus, with measurable lesion.\n* Pre-injury physical activity \\>= 3 sessions\u002Fweek or participation in organized recreational sport.\n* Willingness to follow the standardized rehabilitation protocol and attend all study visits.\n* For participants of childbearing potential: negative pregnancy test at baseline and agreement to use effective contraception during dosing and for 30 days after last dose.\n\nExclusion Criteria:\n\n* Grade III hamstring tear, tendon avulsion, or injury requiring surgical management.\n* Concomitant lower extremity injury that would interfere with rehabilitation or outcome assessment.\n* Prior hamstring strain on the index limb within the past 6 months.\n* Use of systemic corticosteroids, anabolic agents, platelet-rich plasma, stem-cell products, or investigational peptides\u002Fgrowth factors within 30 days prior to screening.\n* Known bleeding disorder or current therapeutic anticoagulation.\n* Significant uncontrolled medical illness (e.g., severe cardiovascular, hepatic, or renal disease) that increases study risk.\n* Known allergy or hypersensitivity to components of the investigational product or placebo.\n* Pregnant or breastfeeding.\n* Current participation in another interventional clinical study or participation within 30 days prior to screening.\n* Currently subject to a formal anti-doping testing program (e.g., WADA\u002FUSADA-aligned) where use of an investigational peptide could create a regulatory conflict, unless explicitly approved by the relevant authority","45 Years",{"count":21,"type":22},[25],"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.",[231,232],"Hamstring Muscle Strain","Skeletal Muscle Injury",[234,235,236,237,238,239,240,241,242,243],"BPC 157","BPC-157","pentadecapeptide","muscle strain","hamstring injury","sports medicine","MRI","return to play","muscle repair","rehabilitation",{"date":214,"type":45},{"date":47,"type":45},{"date":87,"type":22},{"name":51,"class":52},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":276,"locationsCount":53},"100626586","phase-2-melanotan-ii-mt-ii-as-an-adjunct-to-nb-uvb-phototherapy-for-repigmentation-in-stable-nonsegmental-vitiligo-100626586","NCT07437560","Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo","A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Melanotan II (Synthetic Cyclic Melanocortin Receptor Agonist) as an Adjunct to Narrowband UV-B Phototherapy in Adults With Stable Nonsegmental Vitiligo","MTII-VIT","Inclusion Criteria:\n\n* Adults aged 18-65 years able to provide informed consent.\n* Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for \\>=6 months prior to screening.\n* Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography and colorimetry.\n* Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.\n* For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the last dose.\n\nExclusion Criteria:\n\n* Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months.\n* Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by drug\u002Fclass).\n* Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline.\n* Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline.\n* History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator.\n* Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with melanocortin agonist exposure.\n* Pregnant or breastfeeding.\n* Known hypersensitivity to study product components.\n* Participation in another interventional clinical trial within 30 days prior to screening.",{"count":198,"type":22},[25],"This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) as an adjunct to standard NB-UVB phototherapy for repigmentation in adults with stable nonsegmental vitiligo.",[260,261],"NonSegmental Vitiligo","Nonsegmental Vitiligo (Stable)",[263,264,265,266,267,268,269,270,271,272],"Melanotan II","MT-II","melanocortin receptor agonist","MC1R","melanogenesis","skin pigmentation","repigmentation","vitiligo","narrowband UV-B","phototherapy",{"date":214,"type":45},{"date":47,"type":45},{"date":87,"type":22},{"name":51,"class":52},""]