Recruiting
A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
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
ClinicalTrials.gov IDNCT07064486
PhasePHASE3
Enrollment477
SponsorBrightGene Bio-Medical Technology Co., Ltd.
Age18 Years
SexALL
Conditions studied
Type 2 Diabetes (T2DM)
About this study
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
Interventions
- Drug: BGM0504 — Administered SC
- Drug: BGM0504 — Administered SC
- Drug: Semaglutide — Administered SC
Primary outcomes
- Change From Baseline in Hemoglobin A1c (HbA1c) (Week 0 to Week 24)
Eligibility information
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.
Study locations
- RS Universitas Indonesia, Depok, West Java Indonesia
- RSUP Fatmawati, Jakarta, Indonesia
- RSUP Persahabatan, Jakarta, Indonesia
- RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.