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
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
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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…
Interventions
- DrugMET097
Once-weekly MET097 administered via subcutaneous injection
- DrugPlacebo
Once-weekly placebo administered via subcutaneous injection
Locations (196)
- Headlands ResearchScottsdale, Arizona
- Alliance Research InstituteCanoga Park, California
- Clinical Innovations, Inc dba CITrialsRiverside, California
- Peninsula Headlands LLCRolling Hills, California
- Collaborative Neuroscience Research, LLCTorrance, California
- CenExcel Rocky Mountain Clinical Research, LLCEnglewood, Colorado