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

NCT07064486 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BGM0504-Ⅲ-T2DM-02-IDN
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 4

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

Conditions

Type 2 Diabetes (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Change from baseline in HbA1c after 24 weeks of treatment.

  Week 0 to Week 24

Secondary Outcomes (5)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Week 0 to Week 12

• Change From Baseline in Body Weight

  Week 0 to Week 24

• Percentage of Participants With HbA1c Target Value of <7%

  Week 0 to Week 24

• Percentage of Participants With HbA1c Target Value of <5.7%

  Week 0 to Week 24

• Change From Baseline in Fasting Serum Glucose

  Week 0 to Week 24

Study Arms (3)

5 mg BGM0504

EXPERIMENTAL

5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Drug: BGM0504

10 mg BGM0504

EXPERIMENTAL

10 mg BGM0504 administered SC once a week.

Drug: BGM0504

1 mg Semaglutide

ACTIVE COMPARATOR

1 mg semaglutide administered SC once a week

Drug: Semaglutide

Interventions

BGM0504 DRUG

Administered SC

5 mg BGM0504

Semaglutide DRUG

Administered SC

1 mg Semaglutide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ○ 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

You may not qualify if:

• ○ 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.

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (4)

RS Universitas Indonesia

Depok, West Java, Indonesia

RECRUITING

RSUP Fatmawati

Jakarta, Indonesia

RECRUITING

RSUP Persahabatan

Jakarta, Indonesia

RECRUITING

RSUPN Dr. Cipto Mangunkusumo

Jakarta, Indonesia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Tahapary

CONTACT

+62 821 1447 2567; dicky.tahapary@ui.ac.id

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 14, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-03

Locations

ID (4)