Status:
RECRUITING
A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
Lead Sponsor:
Metsera
Conditions:
Obesity and Obesity-related Medical Conditions
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06924320
Start Date
March 3 2025
End Date
January 1 2026
Last Update
April 11 2025
Active Locations (1)
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1
Research Site MET233/097 24-101-001
Cypress, California, United States, 90630