RecruitingPhase 3NCT07743983

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.

Enrollment

372 participants

Start Date

Aug 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BGM0504 and a drug called semaglutide for people with type 2 diabetes (t2dm). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGM0504

Administered as a subcutaneous injection once weekly for 52 weeks.

DRUGsemaglutide

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

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NCT07743983


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