drugset / Trial / NCT06857617
This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity. The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2025-01-03
- Completion
- 2025-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MET097 | Peptide | 0.6 mg | Subcutaneous |
| Subject | MET097 | Peptide | 0.8 mg | Subcutaneous |
| Subject | MET097 | Peptide | 1 mg | Subcutaneous |
| Subject | MET097 | Peptide | 1.2 mg | Subcutaneous |