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

CompletedPhase 2

Sponsor: Pfizer

Conditions: Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM)

Interventions: MET097 Injection, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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

Locations (29)

Bessemer, Alabama, United States
Chula Vista, California, United States
Glendale, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Riverside, California, United States
Bradenton, Florida, United States
Hollywood, Florida, United States
Hollywood, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Riverdale, Georgia, United States
Savannah, Georgia, United States
Morton, Illinois, United States
Naperville, Illinois, United States
Kansas City, Kansas, United States
Columbia, Maryland, United States
Columbia, Maryland, United States
Gaithersburg, Maryland, United States
Garden City, Michigan, United States
Omaha, Nebraska, United States
Berlin, New Jersey, United States
Marlton, New Jersey, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Farmers Branch, Texas, United States
Plano, Texas, United States
Sherman, Texas, United States