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

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later Jul 31, 2026 → Apr 30, 2027
See other at-risk trials from BrightGene Bio-Medical Technology Co., Ltd.

Record History

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  1. Primary and study completion pushed from Jul 31, 2026 to Apr 30, 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 152 participants (planned 477)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised at 4 of 4 sites
  2. Primary and study completion dates: Mar 28, 2026 to Jul 31, 2026
    • Start date: Jun 11, 2025 to Jul 4, 2025
    v3
  3. Site contacts updated at 4 of 4 sitesv2
  4. 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 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
Trial Details
NCT Number NCT07064486
Lead Sponsor BrightGene Bio-Medical Technology Co., Ltd.
Conditions
(from sponsor)		 Type 2 Diabetes (T2DM)
Related terms Diabetes Mellitus, Type 2
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov