[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629982":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":11,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Hudson Biotech","INDUSTRY",[8,16,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention","EXPERIMENTAL",null,[13,14,15],"Drug: Tirzepatide","Drug: Placebo","Behavioral: Reduced-calorie diet",{"label":17,"type":10,"description":11,"interventionNames":18},"Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention",[13,14,15],{"label":20,"type":10,"description":11,"interventionNames":21},"Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention",[13,14,15],{"label":23,"type":10,"description":11,"interventionNames":24},"Arm 4: Placebo once weekly + lifestyle intervention",[13,14,15],[26,31,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","Tirzepatide","(once-weekly SC injection; doses 5\u002F10\u002F15 mg)",[9,17,20,23],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Placebo","(once-weekly SC injection)",[9,17,20,23],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"BEHAVIORAL","Reduced-calorie diet","increased physical activity counseling",[9,17,20,23],[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":56,"coordinates":57},"Point",[58,59],114.0683,22.54554,{"lat":59,"lon":58},[62],{"name":63,"role":43,"phone":64,"phoneExt":11,"email":65},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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",false,"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","ALL","18 Years",{"count":79,"type":80},2539,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86,87],"Obesity","Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities",[28,89,90,91,92,93,94,95,96,97,98,99,100,101],"LY3298176","dual incretin","GIP","GLP-1","obesity","overweight","weight management","placebo","randomized","double-blind","once-weekly","subcutaneous","lifestyle intervention","2026-03-14",{"date":104,"type":105},"2026-03-19","ACTUAL",{"date":107,"type":105},"2026-02-02",{"date":109,"type":80},"2028-03-17",{"name":5,"class":6},1]