Obesity and Overweight
Conditions
Brief summary
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.
Interventions
BIOLOGICAL(Part C) MET097
Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows: * 12 once-weekly doses of 0.6mg followed by a 13th dose of 1.2mg * 12 once-weekly doses of 0.6mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 1.6 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 3.2 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 2.0 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 4.0 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 4.8 mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 2.4mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 4.8mg
BIOLOGICAL(Part C) Placebo
Participants will receive 13 once-weekly subcutaneous injections of matching placebo
Sponsors
Metsera, a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Part A (72 participants), Part B (70 participants), Part C (120 participants)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Part C) Percent change from baseline in body weight at Week 12 (Day 85). | Day 1 (Week 0) to Day 85 (Week 12) |
Secondary
| Measure | Time frame |
|---|---|
| (Part C) To characterize the maximum observed concentration (Cmax). | Day 1 (Week 0) to Day 160 (Week 31) |
| (Part C) To characterize the time of maximum observed concentration (Tmax). | Day 1 (Week 0) to Day 160 (Week 31) |
| (Part C) To characterize the area under the concentration versus time curve (AUC). | Day 1 (Week 0) to Day 160 (Week 31) |
| (Part C) To characterize the elimination half-life (t1/2). | Day 1 (Week 0) to Day 160 (Week 31) |
| (Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12. | Day 1 (Week 0) to Day 85 (Week 12) |
| (Part C) Occurrence of TEAEs following the 13th dose. | Day 85 (Week 12) to Day 160 (Week 31) |
Countries
United States
Outcome results
None listed