RecruitingPhase 1Phase 2NCT06924320

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

Sponsor

Metsera, a wholly owned subsidiary of Pfizer

Enrollment

132 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity and Obesity-related Medical Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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.

Exclusion Criteria11

Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1.
Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit.
Diagnosis of Type 1 diabetes.
For Part A and Part B: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \> 6.4% or fasting plasma glucose \>126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
For Part A and Part B: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
History of bariatric or weight loss surgeries.
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome.
Lifetime history of acute or chronic pancreatitis or pancreatic cancer.
Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.