A Study of BGM0504 in Participants With Type 2 Diabetes

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Mar 20, 2026 → Nov 14, 2026
See other at-risk trials from BrightGene Bio-Medical Technology Co., Ltd.

Record History

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  1. Notable Primary completion pushed from Mar 20, 2026 to Nov 14, 2026 Show 5 more changesShow less
    • Start date: Nov 29, 2024 to Jan 13, 2025
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised
  2. Minor Start date changed from estimate of Dec 1, 2024 to Nov 29, 2024v3
  3. Minor Eligibility criteria revisedv2
  4. Minor 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 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
Trial Details
NCT Number NCT06716216
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 537 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov