NCT06857617

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

A Phase 1/2 Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Doses of MET097 in Adult Participants With Obesity and Overweight But Otherwise Healthy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Metsera, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-01-03
• Completion: 2025-03-15
• First posted: 2025-03-04
• Last updated: 2026-01-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study