A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes (T2DM)
• Interventions: Drug: BGM0504; Drug: Semaglutide

• Registration Number: NCT07064486
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-07-04
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Study First Posted: 2025-07-14
• Last Update Submitted: 2025-10-27
• Last Update Posted: 2025-10-28
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mg BGM0504	BGM0504	5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
10 mg BGM0504	BGM0504	10 mg BGM0504 administered SC once a week.
1 mg Semaglutide	Semaglutide	1 mg semaglutide administered SC once a week

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	Week 0 to Week 24	Change from baseline in HbA1c after 24 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	Week 0 to Week 12	Change from baseline in HbA1c after 12 weeks of treatment.
Change From Baseline in Body Weight	Week 0 to Week 24	Change from baseline in body weight after 24 weeks of treatment.
Percentage of Participants With HbA1c Target Value of <7%	Week 0 to Week 24	Percentage of Participants With HbA1c Target Value of \<7% after 24 weeks of treatment.
Percentage of Participants With HbA1c Target Value of <5.7%	Week 0 to Week 24	Percentage of Participants With HbA1c Target Value of \<5.7%after 24 weeks of treatment.
Change From Baseline in Fasting Serum Glucose	Week 0 to Week 24	Change from baseline in FPG after 24 weeks of treatment.

Trial Locations

Locations (4)

RS Universitas Indonesia; 🇮🇩 Depok, West Java, Indonesia

RSUP Fatmawati; 🇮🇩 Jakarta, Indonesia

RSUP Persahabatan; 🇮🇩 Jakarta, Indonesia

RSUPN Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta, Indonesia