A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Study ID
NCT06974825
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • BGM0504 Administered SC — DRUG
    5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
  • BGM0504 Administered SC — DRUG
    Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
  • BGM0504 Administered SC — DRUG
    Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
  • Semaglutide Administered SC — DRUG
    Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week
  • Placebo Administered SC — DRUG
    Placebo Comparator: Placebo Placebo administered SC once a week.

Study Details

The purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.

Key Dates

Start date
Aug 30, 2023
Status verified
Apr 2024
Primary completion
Aug 13, 2024
Completion
Aug 13, 2024

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 mg BGM0504
  • Experimental: 10 mg BGM0504
  • Experimental: 15 mg BGM0504
  • Experimental: 1 mg Semaglutide
  • Experimental: Placebo

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 0 to Week 12 ]

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