NCT06857617CompletedPhase 1/2
This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity
A Phase 1/2 Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Doses of MET097 in Adult Participants With Obesity and Overweight But Otherwise Healthy
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 14 Jan 2025
- Start date
- 1 Apr 2024
- Primary completion date
- 3 Jan 2025
- Lead sponsor
- Metsera, a wholly owned subsidiary of Pfizer
- Diseases
- Obesity
- NCT number
- NCT06857617
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 120
- From 1 Apr 2024 to the primary completion date, 3 Jan 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
- Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
Other illness
- Diagnosis of diabetes (type 1 or type 2)
- Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type
Other
- Seated blood pressure higher than 160/95 mmHg at the Screening visit
- Elevated resting pulse greater than 100 beats per minute at Screening visit
- Presence of clinically significant ECG abnormalities
Who the study is looking for
- Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
- At least 18 years of age but not older than 70 years of age
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
- Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.