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

NCT ID: NCT06857617

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-03-15

Brief 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.

Conditions

Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

(Part C) MET097

Once-weekly subcutaneous injection of MET097 for 13 weeks

Group Type: EXPERIMENTAL

(Part C) MET097

Intervention Type: 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

Once-weekly subcutaneous injection of Placebo for 13 weeks

Group Type: PLACEBO_COMPARATOR

(Part C) Placebo

Intervention Type: BIOLOGICAL

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

Interventions

(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

Intervention Type: BIOLOGICAL

(Part C) Placebo

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Metsera

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site MET097 23-101-002

Anaheim, California, United States

Research Site MET097 23-101-003

Cypress, California, United States

Research Site MET097 23-101-001

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

MET097-23-101

Identifier Type: -

Identifier Source: org_study_id