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

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

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.