NCT06712836

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

A Phase 2b, Multi-Center, Randomized, Placebo-Controlled Double-Blind Study to Investigate the Safety and Efficacy of Once-Weekly MET097 in Participants With Obesity and Overweight (VESPER-1)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (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 how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index \[BMI\] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.

Conditions

• Obesity
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	MET097	MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
DRUG	Placebo	Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-07-03
• Completion: 2026-05-01
• First posted: 2024-12-02
• Last updated: 2026-02-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study