Trials / Completed
CompletedNCT06897202
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Metsera, a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.
Detailed description
This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index \[BMI\] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 11 weeks after administration of the last dose of study treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MET097 Injection | MET097 is an ultra-long-acting, fully-biased analog of human GLP-1. |
| DRUG | Placebo | Sterile 0.9% (w/v) saline will be used as placebo treatment during the study. |
Timeline
- Start date
- 2025-03-14
- Primary completion
- 2026-01-02
- Completion
- 2026-03-18
- First posted
- 2025-03-26
- Last updated
- 2026-04-17
Locations
29 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06897202. Inclusion in this directory is not an endorsement.