Phase 3Recruiting
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）
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd. (Industry)
- Enrolment
- 372 planned
- Conditions
- Type 2 Diabetes (T2DM)
- Interventions
- BGM0504; semaglutide
- Ages
- adults, older adults
- Registry
- NCT07743983
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered
In the news
TrialsNature Medicine (opens Nature Medicine in a new tab)
Randomized trial investigates kidney protective mechanisms of semaglutide in type 2 diabetes
Researchers examined semaglutide in type 2 diabetes patients using histology, multiparametric MRI, and transcriptomics to understand renal protection.
