RecruitingPhase 3NCT07311850

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

Evaluating The Efficacy and Safety of MET097, a Fully-Biased, Ultra Long-Acting GLP-1RA, In People With Overweight or Obesity: A Phase 3, Multi-Center Randomized, Controlled Trial (VESPER-4)


Sponsor

Metsera, a wholly owned subsidiary of Pfizer

Enrollment

3,500 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria1

  • BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to \<30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

Exclusion Criteria4

  • Have any form of diabetes
  • Have a self-reported body weight change \> 5 kg (11 pounds) within 3 months prior to Screening
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMET097

Once-weekly MET097 administered via subcutaneous injection

DRUGPlacebo

Once-weekly placebo administered via subcutaneous injection


Locations(5)

Research Site 97301-001007

Riverside, California, United States

Research Site 97301-001070

Torrance, California, United States

Research Site 97301-001077

Englewood, Colorado, United States

Research Site 97302-001001

Hollywood, Florida, United States

Research Site 97301-001309

Cary, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07311850


Related Trials