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

Launched by METSERA · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe a new medication called MET097 is for adults who are overweight or have obesity and also have type 2 diabetes. Participants in the study will receive either MET097 or a placebo (a treatment with no active medication) through a weekly injection for 28 weeks. The goal is to see if MET097 helps with weight loss and managing blood sugar levels better than the placebo.

To join the study, participants need to be adults aged 18 and older with a body mass index (BMI) between 27 and 50, and they must have been diagnosed with type 2 diabetes for at least three months. They should also have stable blood sugar levels while on their current diabetes treatment. However, certain individuals, such as those who are pregnant or have a history of serious heart problems, cannot participate. If you decide to join, you can expect regular check-ups and support throughout the study, and you will be randomly assigned to receive either the medication or the placebo.

Gender

ALL

Eligibility criteria

• 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 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
• • Diagnosis of Type 1 diabetes
• • Relevant surgical history including all bariatric or weight loss surgeries