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

Inclusion Criteria5

○ 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 Criteria8

○ 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.