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A Study of BGM0504 in Early T2DM With Obesity
Sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
372
Start Date
2026-08-30
Completion Date
2028-11-30
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
BGM0504
Administered as a subcutaneous injection once weekly for 52 weeks.
semaglutide
Administered as a subcutaneous injection once weekly for 52 weeks.
Locations (1)
Nanjing Drum Tower Hospital(The Affiliated Hospital of Nanjing University Medical School)
Nanjing, Jiangsu, China