NCT07166081

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

A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-diabetic Overweight or Obese

Interventions

Type	Name	Description
DRUG	BGM0504	Administered orally
DRUG	BGM0504	Administered orally
DRUG	BGM0504	Administered orally
DRUG	Placebo	Administered orally
DRUG	BGM0504	Administered orally

Timeline

• Start date: 2025-08-11
• Primary completion: 2026-01-12
• Completion: 2026-05-13
• First posted: 2025-09-10
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study