Clinical trial

A Study of BGM0504 in Early T2DM With Obesity

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07743983

Recruiting nowPhase 3Interventional

What this study is about

This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes (T2DM)

Full registry criteria

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.

Treatments and study arms

BGM0504

Drug

Administered as a subcutaneous injection once weekly for 52 weeks.

semaglutide

Drug

Administered as a subcutaneous injection once weekly for 52 weeks.

Primary outcomes

Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from BaselineWeek 52

Composite endpoint assessing both glycemic control and weight loss.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nanjing Drum Tower Hospital(The Affiliated Hospital of Nanjing University Medical School)🇨🇳 Nanjing, Jiangsu, China