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

Phase 1

Active, not recruiting

• Conditions: Obesity and Overweight
• Interventions: Biological: (Part C) MET097; Biological: (Part C) Placebo

• Registration Number: NCT06857617
• Lead Sponsor: Metsera

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2025-01-03
• Study First Submitted: 2025-01-14
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 262

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Part C) MET097	(Part C) MET097	Once-weekly subcutaneous injection of MET097 for 13 weeks
(Part C) Placebo	(Part C) Placebo	Once-weekly subcutaneous injection of Placebo for 13 weeks

Primary Outcome Measures

Name	Time	Method
(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

Name	Time	Method
(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)

Trial Locations

Locations (3)

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