A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index [BMI] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 11 weeks after administration of the last dose of study treatment.

Inclusion criteria

• BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
• Type 2 diabetes mellitus (*T2DM) for at least 3 months before screening
• Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
• Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening

Exclusion criteria

• Female who is lactating or who is pregnant
• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2
• Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
• Poorly controlled hypertension
• History of stroke
• Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
• Diagnosis of Type 1 diabetes (history of ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM)
• History of acute or chronic pancreatitis
• Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
• Relevant surgical history including all bariatric or weight loss surgeries
• SGLT2 inhibitors and/or metformin
• Had 1 or more episodes of hypoglycemia