A Study of BGM0504 in Early T2DM With Obesity

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.