A Study of BGM0504 in Participants with Type 2 Diabetes

Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Study ID
NCT06716216
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

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

Interventions

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

Study Details

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

Key Dates

Start date
Nov 29, 2024
Status verified
Oct 2024
Primary completion
Mar 20, 2026
Completion
Nov 14, 2026

Study Design

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

Arms

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

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 0 to Week 32 ]

Central Contacts

  • Linong Ji,MD, chief physician, Peking University People's Hospital
    +86 13910978815
    [email protected]

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