BGM0504 added to metformin for people 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

This trial will test whether adding BGM0504 to metformin works as well as semaglutide for adults in Indonesia who have type 2 diabetes and an HbA1c between 7.5% and 11%.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 477 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Depok, West Java and 3 other locations)
• Trial ID: NCT07064486 on ClinicalTrials.gov

What this trial studies

Adults with type 2 diabetes who are on a stable dose of metformin will receive either BGM0504 or semaglutide in addition to their metformin. The study compares blood-sugar control (including changes in HbA1c) and safety outcomes between the two treatment groups. Participants must meet BMI and weight-stability requirements and be treated at one of the Indonesian study hospitals. The trial is a Phase 3 interventional study designed to determine whether BGM0504 provides comparable glucose lowering and an acceptable safety profile versus semaglutide.

Who should consider this trial

Good fit: Ideal candidates are adults in Indonesia with type 2 diabetes who have been on a stable dose of metformin (≥1000–1500 mg/day or the maximum tolerated dose) for at least 8 weeks, have BMI ≥23 kg/m², stable weight, and an HbA1c between 7.5% and 11%.

Not a fit: People with type 1 diabetes, recent or active malignancy, a history of pancreatitis, known allergy to GLP-1 agonists or metformin, or those not meeting the metformin or HbA1c requirements are unlikely to benefit from or qualify for this trial.

Why it matters

Potential benefit: If successful, BGM0504 could provide an additional effective option to improve blood sugar control for people on metformin, potentially increasing local treatment choices.

How similar studies have performed: Other trials of GLP-1 receptor agonists such as semaglutide have shown strong glucose-lowering and weight-loss effects, so this approach builds on established therapies.

Eligibility criteria

Inclusion Criteria:

* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM);

  * Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or \<1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening
  * Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
  * Be of stable weight (± 5%) for at least 3 months before screening;
  * Have HbA1c between ≥7.5% and ≤11.0% at screening

Exclusion Criteria:

* ○ Previous diagnosis of type 1 diabetes, special type diabetes;

  * Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;
  * Have the acute or chronic pancreatitis;
  * Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;
  * Have a serious mental illness or speech impediment and be unable to fully understand the study;
  * Suspected or confirmed history of alcohol or drug abuse;
  * Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year;
  * Other conditions that may impact the assessment of investigational products, as determined by the Investigator.

Where this trial is running

Depok, West Java and 3 other locations

• RS Universitas Indonesia — Depok, West Java, Indonesia (Recruiting)
• RSUP Fatmawati — Jakarta, Indonesia (Recruiting)
• RSUP Persahabatan — Jakarta, Indonesia (Recruiting)
• RSUPN Dr. Cipto Mangunkusumo — Jakarta, Indonesia (Recruiting)

Study contacts

• Study coordinator: Tahapary

Conditions Type 2 Diabetes