A Phase 2b Study to Evaluate the Efficacy and Safety of Once-Monthly MET097 in Adults With Obesity or Overweight

Last updated: May 6, 2025
Sponsor: Metsera
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

MET097

Placebo

Clinical Study ID

NCT06973720
MET097-25-203
  • Ages 18-70
  • All Genders

Study Summary

This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) at Screening of:

  • BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbiditieslisted below)

  • BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the followingweight-related co-morbidities:

  1. Hypertension: on blood pressure (BP)-lowering medication or havingsystolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
  2. Dyslipidemia: on lipid-lowering medication or having low-densitylipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for womenat Screening
  3. Stable body weight (increase or decrease ≤5 kg) within 3 months prior toScreening

Exclusion

Exclusion Criteria:

  • Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% orfasting plasma glucose >125 mg/dL.

  • Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2

  • History of 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

  • Poorly controlled hypertension at, defined as any of the following:

  • Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg atScreening visit

  • A change in antihypertensive medications within 30 days of Screening visit

  • Renal artery stenosis, or evidence of labile blood pressure includingsymptomatic postural hypotension at Screening; postural hypotension is definedas a sustained reduction of systolic blood pressure of at least 20 mmHg ordiastolic blood pressure of 10 mmHg, with or without symptoms during theassessment, within three minutes of standing

  • Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0mIU/L at the Screening visit. Note: participants receiving treatment forhypothyroidism may be included, provided their thyroid hormone replacement dose hasbeen stable for at least 6 months

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: MET097
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
October 31, 2026

Study Description

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of multiple once monthly (QM) dose levels of MET097 after 12 once weekly (QW) doses, compared to placebo. The study will include adult participants with obesity or overweight. Participants will initially receive once weekly MET097 with or without titration or placebo for 12 weeks. Participants will then transition to a four-fold higher monthly dose for a total of 13 monthly doses. The primary endpoint is at Week 28, four weeks after the fourth monthly dose. All participants will be followed for ~5 half-lives after administration of the last dose for safety.

Connect with a study center

  • Research Site 097203-001001

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Research Site 097203-001003

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Research Site 097203-001002

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Research Site 097203-001005

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Research Site 097203-001004

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

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