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

Launched by BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called BGM0504 to see how well and how safely it works for people with type 2 diabetes in Indonesia. The study compares BGM0504 to another diabetes medicine called semaglutide, both added to the usual treatment with metformin, which many people with type 2 diabetes take to control their blood sugar.

People who may join the trial need to be adults diagnosed with type 2 diabetes, have been taking a steady dose of metformin for at least 8 weeks, have a body weight that fits a certain range (measured by BMI of 23 or higher), and have blood sugar levels that are a bit high but not too extreme. Participants should also have had stable weight for at least 3 months. The study is looking for adults of any gender, and it is currently recruiting participants. Those with other types of diabetes, certain recent cancers, severe allergies, serious mental illness, or a history of severe low blood sugar episodes may not be eligible. If you join, you can expect to receive either the new medicine or semaglutide along with your metformin, and the doctors will closely monitor your health and blood sugar to see which treatment works better and is safer.

Gender

ALL

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.