[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652800":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Shanghai Minwei Biotechnology Co., Ltd","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"MWN109 Cohort 1","EXPERIMENTAL",null,[13],"Drug: MWN109 1",{"label":15,"type":10,"description":11,"interventionNames":16},"MWN109 Cohort 2",[17],"Drug: MWN109 2",{"label":19,"type":10,"description":11,"interventionNames":20},"MWN109 Cohort 3",[21],"Drug: MWN109 3",{"label":23,"type":24,"description":11,"interventionNames":25},"Placebo","PLACEBO_COMPARATOR",[26],"Drug: Placebo",[28,33,36,39],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","MWN109 1","Administered SC, QW, 52 weeks",[9],{"type":29,"name":34,"description":31,"armGroupLabels":35,"otherNames":11},"MWN109 2",[15],{"type":29,"name":37,"description":31,"armGroupLabels":38,"otherNames":11},"MWN109 3",[19],{"type":29,"name":23,"description":31,"armGroupLabels":40,"otherNames":11},[23],[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Wanxiang Chen","CONTACT","13359015677","chenwanxiang@minweibiotech.com",[48],{"facility":49,"status":11,"city":50,"state":51,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Peking University People's Hospital","Beijing","Beijing Municipality","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":63,"phoneExt":11,"email":64},"Linong Ji, Doctor of Meicine","13910978815","jiln@bjmu.edu.cn",{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652800","phase-3-phase-3-study-of-mwn109-injection-in-participants-with-overweight-or-obesity-100652800",false,"NCT07778693","Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity","Inclusion Criteria:\n\n1. Male or female aged 18 to 65 years (inclusive) at the time of signing the informed consent form;\n2. Body weight ≥ 70 kg (males) or ≥ 60 kg (females), with BMI ≥ 28 kg\u002Fm² (obesity), or 24 kg\u002Fm² ≤ BMI \\\u003C 28 kg\u002Fm² (overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, polycystic ovary syndrome);\n3. Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead ECG);\n4. Self-reported or documented history of dietary and exercise-based weight management for at least 12 weeks prior to screening, with \\\u003C 5.0% weight change during the 12 weeks prior to screening, and ability to maintain the required diet and exercise behavior during the study;\n5. Participants of childbearing potential must agree to use highly effective contraception from 14 days before signing the ICF until 4 months after the last dose, with no plans for pregnancy or oocyte donation; male participants must agree to use highly effective contraception from signing the ICF until 4 months after the last dose, with no plans for fathering children or sperm donation.\n\nExclusion Criteria:\n\n1. Known allergic constitution (allergy to 3 or more foods or drugs), or allergy to GLP-1 receptor agonists or any component of the investigational product, or severe allergic diseases at screening, or history of severe drug allergy.\n2. Use of any anti-hyperglycemic agents, weight-affecting medications, or prescription weight-loss medications for weight control within 12 weeks prior to screening; over-the-counter weight-loss medications or appetite suppressants within 4 weeks.\n3. Laboratory abnormalities: ALT or AST ≥ 3×ULN; total bilirubin ≥ 1.5×ULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m²; hemoglobin \\\u003C 110 g\u002FL (males) or \\\u003C 100 g\u002FL (females); serum calcitonin ≥ 35 ng\u002FL; TSH \\> 6.0 or \\\u003C 0.4 mIU\u002FL; fasting triglycerides ≥ 5.64 mmol\u002FL; serum amylase or lipase \\> 2.0×ULN.\n4. Known or screening-detected ECG abnormalities with significant safety risk, including: uncontrolled arrhythmias, second-degree or third-degree AV block, ST-T changes suggesting myocardial ischemia, QTcF \\> 450 ms, family history of long QT or Brugada syndrome.\n5. Has a medical history or evidence of any of the following conditions: secondary or drug-induced overweight or obesity; diagnosis of type 1 or type 2 diabetes mellitus in the past or at screening, or at least one laboratory finding suggestive of diabetes identified at screening: HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol\u002FL, random plasma glucose ≥ 11.1 mmol\u002FL, or 2-hour plasma glucose during the oral glucose tolerance test (OGTT) ≥ 11.1 mmol\u002FL; acute or chronic pancreatitis; gallstones\u002Fcholecystitis (with exceptions); thyroid C-cell carcinoma or MEN 2A\u002F2B; prior bariatric surgery (with exceptions); moderate or severe depression (PHQ-9 ≥ 15), other severe psychiatric disorders, or suicidal risk; malignancy within 5 years (with exceptions); cardiac disease within 6 months; premature beats or tachycardia; cerebrovascular event within 6 months; uncontrolled hypertension; thyroid dysfunction; gastric emptying abnormalities; organ transplant history; autoimmune disease; previous or planned weight-loss treatment.\n6. Pregnant or breastfeeding women.\n7. Previous treatment with MWN109 injection.","ALL","18 Years","65 Years",{"count":78,"type":79},760,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity.\n\nApproximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose.\n\nThe study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.",[85],"Overweight , Obesity","NOT_YET_RECRUITING","2026-08-18",{"date":89,"type":90},"2026-08-21","ACTUAL",{"date":92,"type":79},"2026-09-01",{"date":94,"type":79},"2027-11",{"name":5,"class":6},1]