Phase 3 Study Comparing Weekly BGM0504 and Semaglutide Added to Metformin in Adults With Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the efficacy and safety of BGM0504 compared with semaglutide as additional treatment to metformin in adults with type 2 diabetes in Indonesia. This Phase 3 trial aims to assess how well these treatments control blood sugar levels and their safety profiles in patients who have stable diabetes but still need better blood sugar management. Participants will receive either 5 mg or 10 mg of BGM0504 or 1 mg of semaglutide, all given by weekly subcutaneous injections. The study is randomized and open label, meaning participants are randomly assigned to one of these three groups and both participants and researchers know which treatment is given. The treatment period lasts 24 weeks, during which these drugs will be added to the participants ongoing metformin therapy. During the study, participants will have their blood sugar control measured through hemoglobin A1c HbA1c changes from baseline to week 24, along with body weight and fasting serum glucose levels. Assessments will also be made at week 12 for some outcomes. The trial involves safety monitoring and evaluates the percentage of participants reaching specific HbA1c target levels. The full participation duration is 24 weeks, with regular follow-up and assessments throughout this period.

A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia