Overview

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.

Eligibility

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.