A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Study ID
NCT07064486
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 SC
  • BGM0504 — DRUG
    Administered SC
  • Semaglutide — DRUG
    Administered SC

Study Details

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

Key Dates

Start date
Jul 4, 2025
Status verified
Mar 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: 5 mg BGM0504
    5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
  • Experimental: 10 mg BGM0504
    10 mg BGM0504 administered SC once a week.
  • Active Comparator: 1 mg Semaglutide
    1 mg semaglutide administered SC once a week

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 0 to Week 24 ]

Central Contacts

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