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

Last updated: February 13, 2026
Sponsor: Metsera, a wholly owned subsidiary of Pfizer
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hypertriglyceridemia

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Placebo

MET097 Injection

Clinical Study ID

NCT06897202
VESPER-2 (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 ketoacidosis, hyperosmolar state/coma, orany other types of diabetes except T2DM)

  • 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

  • Relevant surgical history including all bariatric or weight loss surgeries

  • SGLT2 inhibitors and/or metformin

  • Had 1 or more episodes of hypoglycemia

Study Design

Total Participants: 133
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 14, 2025
Estimated Completion Date:
March 31, 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 11 weeks after administration of the last dose of study treatment.

Connect with a study center

  • Research Site US-97202-001012

    Chula Vista 5336899, California 5332921 91911
    United States

    Site Not Available

  • Research Site US-97202-001019

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Research Site US-97202-001021

    Los Angeles 5368361, California 5332921 90017
    United States

    Site Not Available

  • Research Site US-97202-001007

    Riverside 5387877, California 5332921 92506
    United States

    Site Not Available

  • Research Site 097202-001001

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Site MET097 24-202-001

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Research Site 097202-001003

    Tampa, Florida 33613
    United States

    Site Not Available

  • Research Site US-97202-001024

    Bradenton 4148708, Florida 4155751 34209
    United States

    Site Not Available

  • Research Site 097202-001001

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • Research Site 097202-001003

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Research Site 097202-001002

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Research Site 097202-001005

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Research Site 097202-001002

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Research Site US-97202-001009

    Riverdale 4219001, Georgia 4197000 30274
    United States

    Site Not Available

  • Research Site 097202-001005

    Savannah 4221552, Georgia 4197000 31405
    United States

    Site Not Available

  • Research Site US-97202-001017

    Morton 4902754, Illinois 4896861 61550
    United States

    Site Not Available

  • Research Site US-97202-001022

    Naperville 4903279, Illinois 4896861 60540
    United States

    Site Not Available

  • Research Site US-97202-001008

    Kansas City 4273837, Kansas 4273857 66112
    United States

    Site Not Available

  • Research Site US-97202-001015

    Columbia 4352053, Maryland 4361885 21045
    United States

    Site Not Available

  • Research Site US-97202-001006

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Site Not Available

  • Research Site US-97202-001004

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Site Not Available

  • Research Site US-97202-001016

    Charlotte 4460243, North Carolina 4482348 28277
    United States

    Site Not Available

  • Research Site 097202-001010

    Cincinnati, Ohio 75234
    United States

    Site Not Available

  • Research Site 097202-001010

    Cincinnati 4508722, Ohio 5165418 75234
    United States

    Site Not Available

  • Research Site US-97202-001023

    Plano 4719457, Texas 4736286 75093
    United States

    Site Not Available

  • Research Site US-97202-001013

    Sherman 4728328, Texas 4736286 75092
    United States

    Site Not Available

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