Actively Recruiting
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
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-10-28
477
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BGM0504 compared with semaglutide as additional treatment to metformin in adults with type 2 diabetes in Indonesia. This Phase 3 trial aims to assess how well these treatments control blood sugar levels and their safety profiles in patients who have stable diabetes but still need better blood sugar management. Participants will receive either 5 mg or 10 mg of BGM0504 or 1 mg of semaglutide, all given by weekly subcutaneous injections. The study is randomized and open label, meaning participants are randomly assigned to one of these three groups and both participants and researchers know which treatment is given. The treatment period lasts 24 weeks, during which these drugs will be added to the participants' ongoing metformin therapy. During the study, participants will have their blood sugar control measured through hemoglobin A1c (HbA1c) changes from baseline to week 24, along with body weight and fasting serum glucose levels. Assessments will also be made at week 12 for some outcomes. The trial involves safety monitoring and evaluates the percentage of participants reaching specific HbA1c target levels. The full participation duration is 24 weeks, with regular follow-up and assessments throughout this period.
CONDITIONS
Brief Title
A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (T2DM)
- On stable treatment with unchanged dose of metformin ≥1500 mg/day or <1500 mg/day but ≥1000 mg/day for at least 8 weeks before screening
- Body mass index (BMI) of 23 kg/m² or higher at screening
- Stable weight (±5%) for at least 3 months before screening
- Hemoglobin A1c (HbA1c) between 7.5% and 11.0% at screening
You will not qualify if you...
- Previous diagnosis of type 1 diabetes or special type diabetes
- History of malignancy within past 5 years except cured basal cell carcinoma of skin or cervical carcinoma in situ, or being evaluated for malignancy
- Acute or chronic pancreatitis
- Allergic to 3 or more foods or medications, or allergic to GLP-1 agonist or metformin, or severe allergic diseases like asthma, urticaria, or eczematous dermatitis
- Serious mental illness or speech impediment preventing full understanding of study
- Suspected or confirmed alcohol or drug abuse
- History of 2 or more severe hypoglycemic episodes in past year
- Other conditions that may affect assessment of investigational products as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive weekly subcutaneous injections of either BGM0504 or Semaglutide as add-on therapy to metformin.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 4 locations
1
RS Universitas Indonesia
Depok, West Java, Indonesia
Actively Recruiting
2
RSUP Fatmawati
Jakarta, Indonesia
Actively Recruiting
3
RSUP Persahabatan
Jakarta, Indonesia
Actively Recruiting
4
RSUPN Dr. Cipto Mangunkusumo
Jakarta, Indonesia
Actively Recruiting
Research Team
T
Tahapary
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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