Study S001274

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）

ClinicalTrials.gov record

Registration

Registration: NCT07743983
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: RECRUITING
Enrollment: 372
Start: 2026-09-17
Primary completion: 2028-09-30
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Conditions: Type 2 Diabetes (T2DM)
Interventions: DRUG:BGM0504; DRUG:semaglutide
Results posted: FALSE

Registered primary outcomes

Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline [Week 52]

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