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RecruitingPhase 3

A Study of BGM0504 in Early T2DM With Obesity

A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）

Assets

BGM0504 / Semaglutide

Listed sites

1

Recruiting sites

1

Estimated enrollment

372

Study population

Type 2 diabetes

Eligibility highlights

•BMI 28-35•HbA1c 7.5-10.5%

Primary endpoint

•HbA1c < 7.0% and Body Weight Reduction ≥ 10%

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07743983
Org study IDBGM0504-Ⅲ -T2DM-03

Timeline

Milestones

Study first posted2026-08-04actual
Study start2026-09-17actual
Last update posted2026-10-13actual
Primary completion2028-09-30estimated
Study completion2028-11-30estimated

Assets

Investigational agents

BGM0504Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.
-BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening.
-Have HbA1c between ≥7.5% and ≤10.5% at screening.
-FPG ≤15.0 mmol/L at screening.
-If hypertensive: SBP <180 mmHg and DBP <110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks.
-Willing to comply with protocol, use effective contraception, and provide informed consent.

Exclusion criteria

•● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.
-Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months.
-History of acute/chronic pancreatitis.
-Medullary thyroid carcinoma, MEN 2A/2B, or family history.
-Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence).
-Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias.
-Hemorrhagic or ischemic stroke within 6 months.
-Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI).
-Pregnant or lactating woman.
-Prior clinical trial participation with investigational drug or device within 3 months.
-Other situations that are deemed as inappropriate for participation by investigators.

Endpoints (17)

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

Weight & body composition
9
Glycemic / diabetes
5
Cardiometabolic biomarkers
2
Safety / tolerability / PK
1

Weight & body composition

9 endpoints
Primary/protocol endpoint

Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline

Time frame:Weeks 12, 24, 36, 44

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline

Time frame:Weeks 12, 24, 36, 44, 52

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline

Time frame:Weeks 12, 24, 36, 44, 52

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment

Time frame:Week 64

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Weeks 12, 24, 36, 44, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in BMI

Time frame:Weeks 12, 24, 36, 44, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference and Hip Circumference

Time frame:Weeks 12, 24, 36, 44, 52

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline

Time frame:Weeks 12, 24, 36, 44, 52

threshold achievement, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Proportion of Participants Achieving Diabetes Remission

Time frame:Week 64 (12 weeks off treatment)

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)

Time frame:Weeks 12, 24, 36, 44, 52

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Weeks 12, 24, 36, 44, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose (FPG)

Time frame:Weeks 12, 24, 36, 44, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in 2-Hour Postprandial Glucose

Time frame:Week 52

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)

Time frame:Weeks 12, 24, 36, 44, 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)

Time frame:Weeks 12, 24, 36, 44, 52

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:Baseline to 64 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.