This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity

Metsera, a wholly owned subsidiary of Pfizer

Status and phase

Completed

Phase 2

Phase 1

Conditions

Obesity and Overweight

Treatments

Biological: (Part C) Placebo

Biological: (Part C) MET097

Study type

Interventional

Funder types

Industry

Identifiers

NCT06857617

MET097-23-101

Details and patient eligibility

About

The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.

The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.

Enrollment

120 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
At least 18 years of age but not older than 70 years of age
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit

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).
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type