Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Study ID
- NCT07166081
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Non-diabetic Overweight or Obese
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- BGM0504 — DRUGAdministered orally
- BGM0504 — DRUGAdministered orally
- BGM0504 — DRUGAdministered orally
- Placebo — DRUGAdministered orally
- BGM0504 — DRUGAdministered orally
Study Details
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.
Key Dates
- Start date
- Aug 11, 2025
- Status verified
- Aug 2025
- Primary completion
- Jan 12, 2026
- Completion
- May 13, 2026
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 120 mg BGM0504 administered orally
- Experimental: Cohort 240 mg BGM0504 administered orally
- Experimental: Cohort 360 mg BGM0504 administered orally
- Placebo Comparator: PlaceboPlacebo administered orally
- Experimental: Cohort 480mg BGM0504 administered orally
Primary Outcome Measure
Number of treatment adverse events [ Time Frame: 11 weeks ]
Central Contacts
- MB ChB240-673-0900
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pharmaron CPC, Inc | Baltimore | Maryland | 21201 | - |
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