NCT06704581

A Study of BGM0504 Injection in Participants with Obesity or Overweight

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants with Overweight or Obese

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	5 mg BGM0504 injection	5mg BGM0504 injection administered subcutaneously (SC) once a week.
DRUG	10 mg BGM0504 injection administered subcutaneously (SC) once a week	10mg BGM0504 injection administered subcutaneously (SC) once a week.
DRUG	15 mg BGM0504 injection	15mg BGM0504 injection administered subcutaneously (SC) once a week.
DRUG	BGM0504 placebo	BGM0504 placebo administered SC once a week.

Timeline

• Start date: 2024-10-28
• Primary completion: 2025-11-27
• Completion: 2026-03-27
• First posted: 2024-11-26
• Last updated: 2024-11-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study