RecruitingPhase 3NCT07064486

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

A Phase 3, Randomized, Open Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Enrollment

477 participants

Start Date

Jul 4, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes (T2DM)

Summary

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests BGM0504 — a new injectable medication for type 2 diabetes — in participants in Indonesia to see if it safely improves blood sugar control in people already taking metformin but whose diabetes is not yet well controlled. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - You are taking metformin at a dose of at least 1,000 mg per day and have been on the same dose for at least 8 weeks - Your HbA1c (average blood sugar measure) is between 7.5% and 11.0% - Your BMI is 23 kg/m² or higher - Your weight has been stable (within 5%) for at least 3 months **You may NOT be eligible if...** - You have type 1 diabetes or other special types of diabetes - You have had cancer in the past 5 years (some exceptions apply) - You have a history of pancreatitis - You have significant kidney, heart, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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