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Sponsor: Pfizer
Conditions: Obesity and Overweight
Interventions: MET233, Placebo
Countries: United States
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity. This study will be conducted in four parts: * Part A will evaluate single ascending doses of MET233 or placebo. * Part B will evaluate multiple ascending doses, with participants receiving five once-weekly doses of MET233 or placebo. * Part C will evaluate once-weekly dosing of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose. * Part D will evaluate a longer dosing schedule, in which participants will receive twelve once-weekly doses, followed by three monthly doses of MET233 or placebo. Participants in this part will be followed for 14 weeks after the final dose.
Sex: ALL
Age: 18 Years to 70 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Adult (≥18 to ≤70 years) male and female participants with obesity or overweight (BMI 27.0 kg/m2 to 38.0 kg/m2, inclusive) but otherwise healthy. Exclusion Criteria: * Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration * Seated blood pressure higher than 160/95 mmHg at the Screening visit * Elevated resting pulse greater than 100 beats per minute at Screening visit * Presence of clinically significant ECG abnormalities * Diagnosis of diabetes (type 1 or type 2) * Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration * Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
- Cypress, California, United States