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

Last updated: April 10, 2025
Sponsor: Metsera
Overall Status: Active - Recruiting

Phase

1

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

MET233 and MET097

MET233

Placebo

Clinical Study ID

NCT06924320
MET233/097-24-101
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 orclinically significant findings from the physical examination. For participants inPart C, no clinically significant diseases except T2DM, well controlledhypertension, and/or dyslipidemia.

  • For participants in Part C, diagnosed with T2DM for at least 3 months beforescreening.

  • 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 toScreening/Visit 1.

Exclusion

Exclusion Criteria:

  • Female who is lactating or who is pregnant according to the pregnancy test atScreening or on Day 1.

  • Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior tothe first study drug administration.

  • Elevated resting pulse greater than 100 beats per minute at Screening visit or priorto 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% orfasting plasma glucose >126 mg/dL at the Screening visit or history of taking anymedications to lower glucose.

  • For Part A and Part B: Participant reported weight-related comorbidity, includingsleep apnea and cardiovascular disease.

  • History of bariatric or weight loss surgeries.

  • Personal or family history of medullary thyroid carcinoma or multiple endocrineneoplasia syndrome.

  • Lifetime history of acute or chronic pancreatitis or pancreatic cancer.

  • Participation in a weight loss program with or without pharmacotherapy during the 3months prior to study administration or plans to do so.

Study Design

Total Participants: 132
Treatment Group(s): 3
Primary Treatment: MET233 and MET097
Phase: 1
Study Start date:
March 03, 2025
Estimated Completion Date:
January 31, 2026

Study 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 5 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.

Connect with a study center

  • Research Site MET233/097 24-101-001

    Cypress, California 90630
    United States

    Active - Recruiting

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