NCT07064486 A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
| NCT ID | NCT07064486 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BrightGene Bio-Medical Technology Co., Ltd. |
| Condition | Type 2 Diabetes (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 477 participants |
| Start Date | 2025-07-04 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 477 participants in total. It began in 2025-07-04 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07064486 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07064486 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 477 participants.
Is NCT07064486 currently recruiting?
Yes, NCT07064486 is actively recruiting participants. Contact the research team at dicky.tahapary@ui.ac.id for enrollment information.
Where is the NCT07064486 trial being conducted?
This trial is being conducted at Depok, Indonesia, Jakarta, Indonesia, Jakarta, Indonesia, Jakarta, Indonesia.
Who is sponsoring the NCT07064486 clinical trial?
NCT07064486 is sponsored by BrightGene Bio-Medical Technology Co., Ltd.. The trial plans to enroll 477 participants.
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