[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657229":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":62,"studyPopulation":11,"armGroups":63,"interventions":81,"overallOfficials":90,"centralContacts":95,"locations":101,"responsibleParty":117,"collaborators":11,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":11,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":11,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":144,"whyStopped":11,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Hangzhou Sciwind Biosciences Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percent change in Body Mass Index (BMI)",null,"Baseline, week 40",[14,17,21,23,25,27,29,31,33,35,37,39,42,45,49],{"measure":15,"description":11,"timeFrame":16},"Percentage of participants with ≥5% of BMI reduction","Baseline, week 40 and week 52",{"measure":18,"description":19,"timeFrame":20},"Change in BMI","Include percent change and absolute change","Baseline, week 52",{"measure":22,"description":11,"timeFrame":20},"Percentage of participants with ≥10% of BMI reduction",{"measure":24,"description":11,"timeFrame":20},"Percentage of participants with ≥15% of BMI reduction",{"measure":26,"description":11,"timeFrame":20},"Percentage of participants with ≥20% of BMI reduction",{"measure":28,"description":19,"timeFrame":20},"Change in body weight",{"measure":30,"description":11,"timeFrame":20},"Change in Glycated Hemoglobin (HbA1c)",{"measure":32,"description":11,"timeFrame":20},"Change in Fasting Plasma Glucose (FPG)",{"measure":34,"description":11,"timeFrame":20},"Change in Fasting Insulin",{"measure":36,"description":11,"timeFrame":20},"Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)",{"measure":38,"description":11,"timeFrame":20},"Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)",{"measure":40,"description":41,"timeFrame":20},"Change in lipid profile","Include triglycerides, LDL-C, HDL-C, total cholesterol",{"measure":43,"description":44,"timeFrame":20},"Change in liver enzymes","Include alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase",{"measure":46,"description":47,"timeFrame":48},"Adverse events","Incidence and severity","From week1 to week 57",{"measure":50,"description":11,"timeFrame":51},"Trough concentration of ecnoglutide","From baseline to week 57 (EOS)",{"allocation":53,"interventionModel":54,"interventionModelDescription":11,"primaryPurpose":55,"observationalModel":11,"timePerspective":11,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":11,"whoMasked":58},"TRIPLE",[59,60,61],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous Ecnoglutide injection or placebo, for up to 52 weeks",[64,70,73,76],{"label":65,"type":66,"description":67,"interventionNames":68},"Ecnoglutide Injection Dose 1","EXPERIMENTAL","once weekly",[69],"Drug: Ecnoglutide Injection",{"label":71,"type":66,"description":67,"interventionNames":72},"Ecnoglutide Injection Dose 2",[69],{"label":74,"type":66,"description":67,"interventionNames":75},"Ecnoglutide Injection Dose 3",[69],{"label":77,"type":78,"description":67,"interventionNames":79},"placebo","PLACEBO_COMPARATOR",[80],"Drug: placebo with matching volume",[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":11},"DRUG","Ecnoglutide Injection","Subcutaneous injection",[65,71,74],{"type":83,"name":88,"description":85,"armGroupLabels":89,"otherNames":11},"placebo with matching volume",[77],[91],{"name":92,"affiliation":93,"role":94},"Junfen Fu, Dr","The Children's Hospital of Zhejiang University School of Medicine","PRINCIPAL_INVESTIGATOR",[96],{"name":97,"role":98,"phone":99,"phoneExt":11,"email":100},"Yao Li","CONTACT","010-67889255","ra@sciwindbio.com",[102],{"facility":103,"status":11,"city":104,"state":105,"zip":11,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Children's Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","China","CN",{"type":109,"coordinates":110},"Point",[111,112],120.16142,30.29365,{"lat":112,"lon":111},[115],{"name":92,"role":98,"phone":116,"phoneExt":11,"email":100},"+86-13777457849",{"type":118,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657229","phase-3-a-study-of-ecnoglutide-injection-in-overweight-or-obese-chinese-adolescents-100657229",false,"NCT07836270","A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Efficacy of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents (SLIMMER-YOUNG)","Inclusion Criteria:\n\n1. At screening, the BMI meets the obesity criteria specified in 'WS\u002FT586-2018 Screening for Overweight and Obesity in School-Aged Children and Adolescents', or it meets the overweight criteria and is accompanied by at least one weight-related comorbidity: hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, etc.\n2. Participant with body weight loss \\\u003C5% by diet and exercise for at least 3 months before screening (per self, parental\u002Flegal report).\n\nExclusion Criteria:\n\n1. Pre-adolescent participants (Tanner phase 1);\n2. History of receiving weight loss surgery or plan to undergo weight loss surgery during the study period (excluding acupuncture-based weight loss, liposuction, or abdominal fat removal procedures conducted more than 1 year prior to screening);\n3. Known secondary obesity, including but not limited to that resulting from: hypercortisolism (e.g. Cushing's syndrome), pituitary or hypothalamic lesions, or monogenic obesity, etc.;\n4. Diagnosis with any type of diabetes;\n5. History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury;\n6. History of using any approved or unapproved drugs for weight loss, antidiabetic drugs, long-term systemic glucocorticoids (more than 14 days), within 3 months prior to screening;","ALL","12 Years","17 Years",{"count":130,"type":131},192,"ESTIMATED","INTERVENTIONAL",[134],"PHASE3","The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents",[137,138],"Adolescents With Obesity","Adolescents With Overweight & Weight-related Comorbidities",[140,141,142,143],"Weight management","ecnoglutide","adolescent","obesity","NOT_YET_RECRUITING","2026-09-19",{"date":147,"type":148},"2026-09-23","ACTUAL",{"date":150,"type":131},"2026-10-31",{"date":152,"type":131},"2028-09-30",{"name":5,"class":6},1]