A Study of BGM0504 in Early T2DM With Obesity

Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Study ID
NCT07743983
Phase
PHASE3
Status
Recruiting
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Conditions

  • Type 2 Diabetes (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BGM0504 — DRUG
    Administered as a subcutaneous injection once weekly for 52 weeks.
  • semaglutide — DRUG
    Administered as a subcutaneous injection once weekly for 52 weeks.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
372 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BGM0504 Injection 15 mg
  • Active Comparator: Semaglutide Injection 1.0 mg

Primary Outcome Measure

Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline [ Time Frame: Week 52 ]

Central Contacts

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