[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650115":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"BrightGene Bio-Medical Technology Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BGM0504 Injection 15 mg","EXPERIMENTAL",null,[13],"Drug: BGM0504",{"label":15,"type":16,"description":11,"interventionNames":17},"Semaglutide Injection 1.0 mg","ACTIVE_COMPARATOR",[18],"Drug: semaglutide",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","BGM0504","Administered as a subcutaneous injection once weekly for 52 weeks.",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"semaglutide",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Zhu","CONTACT","+86025-68182432","zhudalong@nju.edu.cn",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）","RECRUITING","Nanjing","Jiangsu","210008","China","CN",{"type":44,"coordinates":45},"Point",[46,47],118.77778,32.06167,{"lat":47,"lon":46},{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650115","phase-3-a-study-of-bgm0504-in-early-t2dm-with-obesity-100650115",false,"NCT07743983","A Study of BGM0504 in Early T2DM With Obesity","A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）","Inclusion Criteria:\n\n* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet\u002Fexercise, or off antidiabetic therapy ≥8 weeks prior to screening.\n\n  * BMI 28.0-35.0 kg\u002Fm² at screening, with stable weight (±5%) for 3 months prior to screening.\n  * Have HbA1c between ≥7.5% and ≤10.5% at screening.\n  * FPG ≤15.0 mmol\u002FL at screening.\n  * If hypertensive: SBP \\\u003C180 mmHg and DBP \\\u003C110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet\u002Fexercise ≥4 weeks.\n  * Willing to comply with protocol, use effective contraception, and provide informed consent.\n\nExclusion Criteria:\n\n* ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.\n\n  * Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1\u002FGIP\u002FGCG receptor agonists with intolerance\u002Fpoor response, or weight-loss drugs within 3 months.\n  * History of acute\u002Fchronic pancreatitis.\n  * Medullary thyroid carcinoma, MEN 2A\u002F2B, or family history.\n  * Malignancy within 5 years (except treated BCC\u002FSCC, cervical\u002FPSC\u002Fthyroid papillary carcinoma in situ with no recurrence).\n  * Severe cardiac conditions within 6 months: NYHA III\u002FIV HF, unstable angina, MI, CABG\u002Fstent, severe arrhythmias.\n  * Hemorrhagic or ischemic stroke within 6 months.\n  * Severe renal disease or eGFR ≤60 mL\u002Fmin\u002F1.73 m² (CKD-EPI).\n  * Pregnant or lactating woman.\n  * Prior clinical trial participation with investigational drug or device within 3 months.\n  * Other situations that are deemed as inappropriate for participation by investigators.","ALL","18 Years","75 Years",{"count":62,"type":63},372,"ESTIMATED","INTERVENTIONAL",[66],"PHASE3","This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.",[69],"Type 2 Diabetes (T2DM)","2026-07-29",{"date":72,"type":73},"2026-08-04","ACTUAL",{"date":75,"type":63},"2026-08-30",{"date":77,"type":63},"2028-11-30",{"name":5,"class":6},1]