Phase 3 Study of BGM0504 Injection Compared to Placebo in Adults with Type 2 Diabetes Not Controlled by Diet and Exercise

What this Trial Is About

Researchers are evaluating the effects of BGM0504 in Chinese patients with type 2 diabetes who have poor blood sugar control managed only by diet and exercise. This phase III clinical trial aims to assess the benefits and safety of BGM0504 injections over 32 weeks compared to a placebo, with extended monitoring for up to 52 weeks to evaluate longer-term effects. Participants receive weekly subcutaneous injections of either 5 mg or 10 mg of BGM0504, or a placebo, in a randomized and double-blind manner. The study includes a main treatment period of 32 weeks, during which the primary outcome of blood sugar control measured by hemoglobin A1c is evaluated, followed by continued treatment and assessment up to 52 weeks for additional safety and efficacy measures. During the trial, participants will undergo regular assessments including blood tests to measure hemoglobin A1c, fasting glucose, and body weight. These evaluations occur at specified intervals to monitor changes from baseline. Safety and treatment adherence will also be closely followed throughout the study period, which lasts up to 52 weeks for each participant.

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise