drugset / Trial / NCT06857617

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

NCT06857617

Phase 1/2 Completed 120 enrolled Metsera, a wholly owned subsidiary of Pfizer
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-04-01
Primary completion
2025-01-03
Completion
2025-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject MET097 Peptide 0.6 mg Subcutaneous
Subject MET097 Peptide 0.8 mg Subcutaneous
Subject MET097 Peptide 1 mg Subcutaneous
Subject MET097 Peptide 1.2 mg Subcutaneous

Indications