NCT06973720

A Phase 2b Study to Evaluate the Efficacy and Safety of Once-Monthly MET097 in Adults With Obesity or Overweight

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of Multiple Dose Regimens of Once-Weekly Switching to Once-Monthly MET097 in Participants With Obesity or Overweight (VESPER-3)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Metsera, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of multiple once monthly (QM) dose levels of MET097 after 12 once weekly (QW) doses, compared to placebo. The study will include adult participants with obesity or overweight. Participants will initially receive once weekly MET097 with or without titration or placebo for 12 weeks. Participants will then transition to a four-fold higher monthly dose for a total of 13 monthly doses. The primary endpoint is at Week 28, four weeks after the fourth monthly dose. All participants will be followed for \~5 half-lives after administration of the last dose for safety.

Conditions

• Obesity
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	MET097	For subcutaneous administration.
DRUG	Placebo	Sterile 0.9% (w/v) saline for subcutaneous administration.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-12
• Completion: 2026-10-01
• First posted: 2025-05-15
• Last updated: 2026-02-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study