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)
Metsera, a wholly owned subsidiary of Pfizer
3,501 participants
Dec 19, 2025
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
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
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Interventions
Once-weekly MET097 administered via subcutaneous injection
Once-weekly placebo administered via subcutaneous injection
Locations(195)
View Full Details on ClinicalTrials.gov
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NCT07311850