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A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT07064486•BrightGene Bio-Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

RS Universitas Indonesia

Depok, West Java, Indonesia

RSUP Fatmawati

Jakarta, Indonesia

RSUP Persahabatan

Jakarta, Indonesia

RSUPN Dr. Cipto Mangunkusumo

Jakarta, Indonesia

Key Dates

Start Date

July 4, 2025

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

October 28, 2025

Enrollment

477

ESTIMATED participants

Conditions

Type 2 Diabetes (T2DM)

Interventions

BGM0504

DRUG

BGM0504

DRUG

Semaglutide

DRUG

Contacts

Tahapary

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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