A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of Multiple Dose Regimens of Once-Weekly Switching to Once-Monthly MET097 in Participants With Obesity or Overweight (VESPER-3)
NCT: NCT06973720 ·
Status: ACTIVE NOT RECRUITING ·
Phase: Phase 2
· Sponsor: Metsera, a wholly owned subsidiary of Pfizer
· Started: 2025-04-01
· Est. Completion: 2026-10
Official Summary
This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 250 participants
Interventions
- DRUG: MET097 — For subcutaneous administration.
- DRUG: Placebo — Sterile 0.9% (w/v) saline for subcutaneous administration.
Primary Outcomes
- Percent change from baseline in body weight at Week 28 (Baseline (Week 0) through Week 28 (Day 197))
Secondary Outcomes
- Percent change from baseline in body weight at Week 64 (Baseline (Week 0) through Week 64 (Day 449))
- Percent change from baseline in body weight at all other post-baseline weight measurements up to Week 64 other than Week 28 (Baseline (Week 0) through Week 24 (Day 169); Week 32 (Day 225) through Week 64 (Day 449))
- Change from baseline in absolute bodyweight (in kg) at all protocol-specified weekly and monthly post-baseline measurements (Baseline (Week 0) through Week 64 (Day 449))
- Change from baseline in body mass index (BMI) at all protocol-specified weekly and monthly post-baseline measurements (Baseline (Week 0) through Week 64 (Day 449))
- Change from baseline in waist circumference (in cm) at all protocol-specified weekly and monthly post-baseline measurements (Baseline (Week 0) through Week 64 (Day 449))
Trial Locations
- Research Site 097203-001001, Hollywood, Florida, United States
- Research Site 097203-001003, Tampa, Florida, United States
- Research Site 097203-001002, Decatur, Georgia, United States
- Research Site 097203-001005, Savannah, Georgia, United States
- Research Site 097203-001004, Marlton, New Jersey, United States
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