NCT06924320

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

A Phase 1 Randomized, Double-Blind, Placebo Controlled. Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 Co-administered With MET097 in Adult Participants With Obesity or Overweight Including Participants With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Metsera, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

Detailed description

This is a randomized, placebo-controlled, double-blind, double-dummy study to investigate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of MET233 co-administered with MET097 in adult participants with a BMI of 27 to 38 kg/m2, including some participants with T2DM. For Part A, after the up to 4-week screening period, the study includes 1 dose and a 12-week safety follow-up after administration. For Part B and Part C, after the up to 4-week screening period, the study includes 12 once-weekly doses and an approximately 11-week safety follow-up after the last administration. Parts A and B will include only participants with overweight or obesity without type 2 diabetes. Part C will include participants with overweight or obesity who also have type 2 diabetes.

Conditions

• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
DRUG	MET233 and MET097	For subcutaneous administration
DRUG	Placebo	Sterile 0.9% (w/v) saline for subcutaneous administration.
DRUG	MET233	For subcutaneous administration

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-01-25
• Completion: 2027-03-15
• First posted: 2025-04-11
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study