A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Dec 29, 2025 → Nov 14, 2026
See other at-risk trials from BrightGene Bio-Medical Technology Co., Ltd.

Record History

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  1. Primary completion pushed from Dec 29, 2025 to Nov 14, 2026 Show 6 more changesShow less
    • Start date: Dec 2, 2024 to Jan 3, 2025
    • Enrollment closed, study ongoing
    • Study completion pushed from Aug 25, 2026 to Nov 14, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised
  2. Start date changed from estimate of Dec 1, 2024 to Dec 2, 2024v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
Trial Details
NCT Number NCT06716203
Lead Sponsor BrightGene Bio-Medical Technology Co., Ltd.
Collaborators: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Conditions
(from sponsor)		 Type 2 Diabetes Mellitus (T2DM)
Related terms Diabetes Mellitus, Type 2
Enrollment 207 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov