A Study of BGM0504 in Early T2DM With Obesity

Recruiting now · Phase 3

Conditions studied: Type 2 Diabetes (T2DM)

In brief

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.

Key facts

Study ID

NCT07743983

Run by

BrightGene Bio-Medical Technology Co., Ltd.

People needed

372

Starts

2026-08-30

Expected to finish

2028-11-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ○ 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.

You may not qualify if…

• ● 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.

Where it is running

• Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School） — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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