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RECRUITING
NCT07743983
PHASE3

A Study of BGM0504 in Early T2DM With Obesity

Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

BGM0504

Administered as a subcutaneous injection once weekly for 52 weeks.

DRUG

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