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

NCT06857617 | Completed Phase 1 FDA Drug

• 1 other identifier: MET097-23-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

  Day 1 (Week 0) to Day 85 (Week 12)

Secondary Outcomes (6)

• (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)

Study Arms (2)

(Part C) MET097

EXPERIMENTAL

Once-weekly subcutaneous injection of MET097 for 13 weeks

Biological: (Part C) MET097

(Part C) Placebo

PLACEBO COMPARATOR

Once-weekly subcutaneous injection of Placebo for 13 weeks

Biological: (Part C) Placebo

Interventions

(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) MET097

(Part C) Placebo BIOLOGICAL

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

(Part C) Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Metsera, a wholly owned subsidiary of Pfizer: lead

Study Sites (3)

Research Site MET097 23-101-002

Anaheim, California, 92801, United States

Location

Research Site MET097 23-101-003

Cypress, California, 90630, United States

Location

Research Site MET097 23-101-001

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A (72 participants), Part B (70 participants), Part C (120 participants)

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: March 4, 2025
• Study Start: April 1, 2024
• Primary Completion: January 3, 2025
• Study Completion: March 15, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (3)