Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Jan 12, 2026 to May 13, 2026
    • Primary completion date: May 13, 2026 to Mar 16, 2026
    • Study completion date: May 13, 2026 to Jul 15, 2026
  2. Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Jan 12, 2026 to May 13, 2026
    • Eligibility criteria expanded, about 11 words
    • Site details revised
  3. Interventions: BGM0504 (Drug), BGM0504 (Drug), BGM0504 (Drug), Placebo (Drug) to BGM0504 (Drug), BGM0504 (Drug), BGM0504 (Drug), BGM0504 (Drug), Placebo (Drug)
    • Study arms: 4 to 5
    v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral administrations in non-diabetic overweight or obese adult subjects.
Trial Details
NCT Number NCT07166081
Lead Sponsor BrightGene Bio-Medical Technology Co., Ltd.
Conditions
(from sponsor)		 Non-diabetic Overweight or Obese
Related terms Obesity
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov