A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM)
In brief
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.
Key facts
- Study ID
- NCT06897202
- Run by
- Pfizer
- People needed
- 133
- Starts
- 2025-03-14
- Expected to finish
- 2026-03-18
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- KUR Research — Bessemer, Alabama, United States
- ProSciento, Inc. — Chula Vista, California, United States
- Michael Roberts Opthamologist (Eye Exam) — Glendale, California, United States
- Eye Treatment Center — Long Beach, California, United States
- Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
- Velocity Clinical Research, Los Angeles — Los Angeles, California, United States
- Clinical Innovations, Inc dba CITrials — Riverside, California, United States
- Synergy Healthcare — Bradenton, Florida, United States
- Miami Eye Institute — Hollywood, Florida, United States
- Research Centers of America — Hollywood, Florida, United States
- ForCare Clinical Research — Tampa, Florida, United States
- CenExel iResearch, LLC — Decatur, Georgia, United States
- EmVenio Research Centre at PRIME Healthcare — Riverdale, Georgia, United States
- CenExel iResearch, LLC — Savannah, Georgia, United States
- Koch Family Medicine Clinical Research — Morton, Illinois, United States
- Bioluminux Clinical Research — Naperville, Illinois, United States
- EmVenio Research Centre at PRIME Healthcare — Kansas City, Kansas, United States
- Eagle Eye Care — Columbia, Maryland, United States
- KUR Research, LLC — Columbia, Maryland, United States
- CBH Health, LLC. — Gaithersburg, Maryland, United States
- Emvenio Research — Garden City, Michigan, United States
- Velocity Clinical Research — Omaha, Nebraska, United States
- Advocare Berlin Medical Associates — Berlin, New Jersey, United States
- Hassman Research Institute — Marlton, New Jersey, United States
- Onsite Clinical Solutions, LLC (Satellite site) — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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