[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644625":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":26,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Receive LAE102, once a week, by subcutaneous injection.",[13],"Drug: LAE102 +Tirzepatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Receive the LAE102 placebo, once a week, by subcutaneous injection.",[19],"Drug: LAE102 placebo,+Tirzepatide",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","LAE102 +Tirzepatide","Receive LAE102, once a week, by subcutaneous injection.The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased every 4 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"LAE102 placebo,+Tirzepatide","Receive the LAE102 placebo, once a week, by subcutaneous injection. The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased to a higher dose level every 4 weeks.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiaoying li Professor","CONTACT","+862164041990","li.xiaoying@zs-hospital.sh.cn",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100644625",false,"NCT07671391","A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants","A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the Informed Consent Form (ICF);\n2. Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;\n3. BMI ranging from 28.0 to 40.0 kg\u002Fm2 during the screening;\n4. Self-reporting at least one experience of weight loss failure after adjusting diet and exercise, and within the previous 3 months, the weight change after only dietary and exercise adjustments was less than 5%;\n\nExclusion Criteria:\n\n1. A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes);\n2. Screening criteria: Glycated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol\u002FL.\n\n   Obesity related:\n3. Diagnosed with secondary obesity;\n4. Previously underwent surgical or endoscopic weight loss metabolic surgery (except for local liposuction within 1 year before screening) or gastric balloon implantation, or planned to undergo any weight loss surgery or receive other weight loss treatments during the study;\n5. Uncontrolled thyroid disease, or screening criteria.","ALL","18 Years","75 Years",{"count":49,"type":50},60,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","This study is a randomized, double-blind, placebo-controlled trial aimed at exploring the effects of LAE102 injection in combination with Tirzepatide on body composition.",[56],"Obesity Adult Onset",[58,56,59],"LAE102 injection","Investigator-initiated trial","NOT_YET_RECRUITING","2026-06-22",{"date":63,"type":64},"2026-06-26","ACTUAL",{"date":66,"type":50},"2026-08",{"date":68,"type":50},"2027-12",{"name":5,"class":6}]