Phase III Study of BGM0504 Injection for Weight Management in Chinese Adults with Overweight or Obesity Evaluating Safety and Effectiveness with Weekly Subcutaneous Doses

What this Trial Is About

Researchers are evaluating the clinical effects of BGM0504 injection in Chinese adults who are overweight or obese but do not have diabetes. This phase III randomized, double-blind, placebo-controlled study aims to measure how BGM0504 works alongside diet, exercise, and behavioral changes for weight management over 36 weeks, and also assess its safety and effectiveness over 52 weeks. Participants will receive weekly subcutaneous injections of either 5 mg, 10 mg, or 15 mg of BGM0504, or a placebo injection, while continuing diet and exercise interventions. The study includes a 36-week treatment period focused on weight change and a longer 52-week period to evaluate sustained effects and safety. During the study, participants will have regular assessments including body weight, waist circumference, body mass index BMI, fasting glucose, and hemoglobin A1c HbA1c measurements at baseline, 36 weeks, and 52 weeks. Researchers will monitor changes in these outcomes, particularly the percentage of participants achieving at least 5% weight loss by week 36. Safety and tolerability will also be tracked throughout participation, which lasts up to 52 weeks.

A Study of BGM0504 Injection in Participants with Obesity or Overweight