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NCT Number: NCT07064486

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RS Universitas Indonesia, Depok, West Java, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGM0504

Drug

Administered SC

semaglutide

Drug

Administered SC

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Week 0 to Week 24

    Change from baseline in HbA1c after 24 weeks of treatment.

Secondary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Week 0 to Week 12

    Change from baseline in HbA1c after 12 weeks of treatment.

  2. Change From Baseline in Body Weight

    Time frame: Week 0 to Week 24

    Change from baseline in body weight after 24 weeks of treatment.

  3. Percentage of Participants With HbA1c Target Value of <7%

    Time frame: Week 0 to Week 24

    Percentage of Participants With HbA1c Target Value of <7% after 24 weeks of treatment.

  4. Percentage of Participants With HbA1c Target Value of <5.7%

    Time frame: Week 0 to Week 24

    Percentage of Participants With HbA1c Target Value of <5.7%after 24 weeks of treatment.

  5. Change From Baseline in Fasting Serum Glucose

    Time frame: Week 0 to Week 24

    Change from baseline in FPG after 24 weeks of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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