DelfaGLP-1 Atlas

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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

Assets

BGM0504 / Semaglutide

Listed sites

4

Recruiting sites

4

Enrollment

477

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7.5-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07064486
Org study IDBGM0504-Ⅲ-T2DM-02-IDN

Timeline

Milestones

Study start2025-07-04actual
Study first posted2025-07-14actual
Last update posted2025-10-28actual
Primary completion2026-07-31estimated
Study completion2026-07-31estimated

Assets

Investigational agents

BGM0504Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
5
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0 to Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Week 0 to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Week 0 to Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <7%

Time frame:Week 0 to Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <5.7%

Time frame:Week 0 to Week 24

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Week 0 to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.