A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overw… (NCT06897202) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
United States133 participantsStarted 2025-03-14
Plain-language summary
This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* S…
What they're measuring
1
Percent change from baseline in body weight at Week 28 (Day 197)
Timeframe: Baseline (Week 0) through Week 28 (Day 197)
Trial details
NCT IDNCT06897202
SponsorMetsera, a wholly owned subsidiary of Pfizer