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)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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)
Locations
United States
California
Research Site 97301-001007
RECRUITING
Riverside
Research Site 97301-001070
RECRUITING
Torrance
Colorado
Research Site 97301-001077
RECRUITING
Englewood
Florida
Research Site 97302-001001
RECRUITING
Hollywood
North Carolina
Research Site 97301-001309
RECRUITING
Cary
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2028-05
Participants
Target number of participants: 3500
Treatments
Experimental: MET097 Dose 1
Participants will receive MET097 administered subcutaneously
Experimental: MET097 Dose 2
Participants will receive MET097 administered subcutaneously
Experimental: MET097 Dose 3
Participants will receive MET097 administered subcutaneously
Placebo_comparator: Placebo
Once-weekly placebo administered via subcutaneous injection
Related Therapeutic Areas
Sponsors
Leads: Metsera, a wholly owned subsidiary of Pfizer