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

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.

Study Overview

• Status: Completed
• Conditions: Obesity and Overweight
• Intervention / Treatment: Biological: (Part C) MET097; Biological: (Part C) Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Research Site MET097 23-101-002
    • Cypress, California, United States, 90630
      • Research Site MET097 23-101-003
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Research Site MET097 23-101-001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (Part C) MET097; Once-weekly subcutaneous injection of MET097 for 13 weeks	Biological: (Part C) MET097; 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
Placebo Comparator: (Part C) Placebo; Once-weekly subcutaneous injection of Placebo for 13 weeks	Biological: (Part C) Placebo; Participants will receive 13 once-weekly subcutaneous injections of matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(Part C) Percent change from baseline in body weight at Week 12 (Day 85).	Day 1 (Week 0) to Day 85 (Week 12)

Secondary Outcome Measures

Outcome Measure	Time Frame
(Part C) To characterize the maximum observed concentration (Cmax).	Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the time of maximum observed concentration (Tmax).	Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the area under the concentration versus time curve (AUC).	Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the elimination half-life (t1/2).	Day 1 (Week 0) to Day 160 (Week 31)
(Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.	Day 1 (Week 0) to Day 85 (Week 12)
(Part C) Occurrence of TEAEs following the 13th dose.	Day 85 (Week 12) to Day 160 (Week 31)

Collaborators and Investigators

• Sponsor: Metsera

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: MET097-23-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No