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OpenTrials
Completed

NCT Number: NCT06857617

This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity

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.

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Key information

Conditions

Obesity and Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site MET097 23-101-002, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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
  • Diagnosis of diabetes (type 1 or type 2)
  • Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
  • 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

Treatment and study plan

(Part C) MET097

Biological

Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows:

  • 12 once-weekly doses of 0.6mg followed by a 13th dose of 1.2mg
  • 12 once-weekly doses of 0.6mg followed by a 13th dose of 2.4 mg
  • 12 once-weekly doses of 0.8 mg followed by a 13th dose of 1.6 mg
  • 12 once-weekly doses of 0.8 mg followed by a 13th dose of 3.2 mg
  • 12 once-weekly doses of 1.0 mg followed by a 13th dose of 2.0 mg
  • 12 once-weekly doses of 1.0 mg followed by a 13th dose of 4.0 mg
  • 12 once-weekly doses of 1.2 mg followed by a 13th dose of 2.4 mg
  • 12 once-weekly doses of 1.2 mg followed by a 13th dose of 4.8 mg
  • Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 2.4mg
  • Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 4.8mg

(Part C) Placebo

Biological

Participants will receive 13 once-weekly subcutaneous injections of matching placebo

Primary outcomes

  1. (Part C) Percent change from baseline in body weight at Week 12 (Day 85).

    Time frame: Day 1 (Week 0) to Day 85 (Week 12)

Secondary outcomes

  1. (Part C) To characterize the maximum observed concentration (Cmax).

    Time frame: Day 1 (Week 0) to Day 160 (Week 31)

  2. (Part C) To characterize the time of maximum observed concentration (Tmax).

    Time frame: Day 1 (Week 0) to Day 160 (Week 31)

  3. (Part C) To characterize the area under the concentration versus time curve (AUC).

    Time frame: Day 1 (Week 0) to Day 160 (Week 31)

  4. (Part C) To characterize the elimination half-life (t1/2).

    Time frame: Day 1 (Week 0) to Day 160 (Week 31)

  5. (Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.

    Time frame: Day 1 (Week 0) to Day 85 (Week 12)

  6. (Part C) Occurrence of TEAEs following the 13th dose.

    Time frame: Day 85 (Week 12) to Day 160 (Week 31)

Sponsors and collaborators

Lead sponsor

Metsera, a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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