Phase 3 Trial Comparing BGM0504 and Semaglutide Injections for Early Type 2 Diabetes and Obesity in Chinese Adults

What this Trial Is About

Researchers are evaluating the effects of BGM0504 Injection 15 mg compared to semaglutide 1.0 mg in Chinese adults with early type 2 diabetes and obesity who have not achieved adequate control through diet and exercise. This phase 3 trial aims to assess the efficacy and safety of these treatments over a 52-week period, with a focus on diabetes remission 12 weeks after stopping treatment. Participants receive either BGM0504 or semaglutide as a subcutaneous injection once weekly for 52 weeks. The study compares these two active treatments to evaluate improvements in blood sugar control and weight loss. After the treatment period, participants are monitored for 12 weeks without treatment to assess the rate of diabetes remission. During the study, participants will have regular assessments including measurements of blood sugar levels HbA1c, fasting plasma glucose, postprandial glucose, body weight, body mass index, waist and hip circumference, blood pressure, and lipid profiles. Safety is monitored throughout the 64-week period, including tracking any adverse events. The main outcome is the proportion of participants who achieve target blood sugar and weight loss goals by week 52, with additional follow-up at week 64 to evaluate lasting effects.

A Study of BGM0504 in Early T2DM With Obesity