A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

Last updated: April 9, 2025
Sponsor: Metsera
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Hypertriglyceridemia

Diabetes And Hypertension

Treatment

Placebo

MET097 Injection

Clinical Study ID

NCT06897202
MET097-24-202
  • Ages 18-75
  • All Genders

Study Summary

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening

  • Type 2 diabetes mellitus (*T2DM) for at least 3 months before screening

  • Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3mmol/mol) at Screening and treated with stable therapy for at least 30 days prior toScreening/Visit 1 (diet and exercise alone or in combination with metforminmonotherapy and/or SGLT-2)

  • Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening

Exclusion

Exclusion Criteria:

  • Female who is lactating or who is pregnant

  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2

  • Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)

  • Poorly controlled hypertension

  • History of stroke

  • Significant cardiovascular disease including but not limited to unstable angina orvalvular heart disease or has a history of myocardial infarction, coronary arterybypass graft, percutaneous coronary artery re-vascularization, or congestive heartfailure

  • Diagnosis of Type 1 diabetes

  • History of acute or chronic pancreatitis

  • Family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2)

  • History of significant active or unstable major depressive disorder (MDD) or othersevere psychiatric disorder within the last 2 years

  • Diagnosis of Type 1 diabetes

  • Relevant surgical history including all bariatric or weight loss surgeries

Study Design

Total Participants: 125
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 14, 2025
Estimated Completion Date:
June 30, 2026

Study Description

This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index [BMI] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.

Connect with a study center

  • Research Site 097202-001001

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Research Site MET097 24-202-001

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Research Site 097202-001003

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Research Site 097202-001002

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Research Site 097202-001005

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Research Site 097202-001010

    Cincinnati, Ohio 75234
    United States

    Active - Recruiting

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