GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 3

A Study of BGM0504 in Participants with Type 2 Diabetes

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Assets

BGM0504 / Semaglutide

Listed sites

Recruiting sites

Enrollment

537

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 IDNCT06716216

Org study IDBGM0504-Ⅲ -T2DM-02

Timeline

Milestones

Study start2024-11-29actual

Study first posted2024-12-04actual

Last update posted2025-02-07actual

Primary completion2026-03-20estimated

Study completion2026-11-14estimated

Assets

Investigational agents

BGM0504 Semaglutide

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);

–Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose <1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.

–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%；

Exclusion criteria

•■ Previous diagnosis of type 1 diabetes, special type diabetes;

–There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).

–Have had chronic or acute pancreatitis any time prior to study entry;

–Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;

–Mentally incapacitated or speech-impaired;

–Suspected or confirmed history of alcohol or drug abuse;

–Pregnant or lactating woman;

–The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

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

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0 to Week 52

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 32

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 52

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 52

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 52

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 52

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.