[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631827":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":39,"locations":45,"responsibleParty":65,"collaborators":27,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Hudson Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MOTS-c","EXPERIMENTAL","Participants receive investigational MOTS-c plus standardized lifestyle counseling.",[13,14,15],"Drug: MOTS-c (MDP)","Other: Route Subcutaneous injection","Other: Regimen",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo plus standardized lifestyle counseling.",[21,14,15],"Drug: Placebo",[23,28,30,35],{"type":24,"name":25,"description":13,"armGroupLabels":26,"otherNames":27},"DRUG","MOTS-c (MDP)",[9],null,{"type":24,"name":17,"description":21,"armGroupLabels":29,"otherNames":27},[17],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"OTHER","Route Subcutaneous injection","injection",[9,17],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"Regimen","Fixed dose once daily for 12 weeks",[9,17],[40],{"name":41,"role":42,"phone":43,"phoneExt":27,"email":44},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":55,"coordinates":56},"Point",[57,58],114.0683,22.54554,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":27,"email":64},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":66,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":79,"type":80},120,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86,87,88],"Prediabetes","Insulin Resistance","Overweight\u002FObesity",[9,90,91,92,93,94,95,96,97],"mitochondrial-derived peptide","MDP","insulin sensitivity","AMPK","prediabetes","metabolic syndrome","OGTT","HbA1c","2026-03-26",{"date":100,"type":101},"2026-04-01","ACTUAL",{"date":103,"type":101},"2026-02-02",{"date":105,"type":80},"2028-05-17",{"name":5,"class":6},1]