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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening
• For participants in Part A and B, no history of clinically significant diseases or clinically significant findings from the physical examination. For participants in Part C, no clinically significant diseases except T2DM, well controlled hypertension, and/or dyslipidemia.
• For participants in Part C, diagnosed with T2DM for at least 3 months before screening.
• For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5% at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1.
Locations
United States
California
Research Site MET233/097 24-101-001
RECRUITING
Cypress
Contact Information
Primary
Metsera Recruiting
clinicaltrials@metsera.com
888-746-7403
Time Frame
Start Date:2025-03-03
Estimated Completion Date:2026-01
Participants
Target number of participants:132
Treatments
Experimental: SAD: MET233 co-administered with MET097
Participants in the single ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 at a single point in time.
Placebo_comparator: SAD: Placebo
Participants in the single ascending dose cohorts will receive subcutaneous Placebo at a single point in time.
Experimental: MAD: MET233 co-administered with MET097
Participants in the multiple ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 weekly.
Placebo_comparator: MAD: Placebo
Participants in the multiple ascending dose cohorts will receive subcutaneous Placebo weekly.
Experimental: MAD: MET233 co-administered with Placebo
Participants will receive subcutaneous MET233 co-administered with Placebo weekly.