A Study of BGM0504 in Early T2DM With Obesity

NCT07743983 · Recruiting

Last updated 2026-08-27

This clinical trial is testing the safety and effects of the medication BGM0504 in adults with early type 2 diabetes and obesity to see if it helps lower blood sugar and reduce body weight.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 372 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2026-08 · est. completion 2028-11

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT07743983 ↗

Description as written by the study sponsor.

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.

Treatments tested

BGM0504 Drug

Administered as a subcutaneous injection once weekly for 52 weeks.
semaglutide Drug

Administered as a subcutaneous injection once weekly for 52 weeks.

Main thing measured	Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
Sponsor	BrightGene Bio-Medical Technology Co., Ltd.
Conditions studied	Type 2 Diabetes (T2DM)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07743983 ↗