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NCT07064486Active, not recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
152 (actual)
First submitted
11 Jul 2025
Start date
Jul 2025
Primary completion date
Apr 2027
Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
NCT number
NCT07064486

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 152
  • From Jul 2025 to the primary completion date, Apr 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • ○ 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.

Who the study is looking for

  • ○ 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RS Universitas Indonesia
Coordinator of this site? Confirm its status
DepokIndonesiaUnknown status
RSUP Fatmawati
Coordinator of this site? Confirm its status
JakartaIndonesiaUnknown status
RSUPN Dr. Cipto Mangunkusumo
Coordinator of this site? Confirm its status
JakartaIndonesiaUnknown status
RSUP Persahabatan
Coordinator of this site? Confirm its status
JakartaIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.