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

Last updated: June 11, 2026
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Hypertriglyceridemia

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

Placebo

MET097 Injection

Clinical Study ID

NCT06897202
VESPER-2 (MET097-24-202)
C6491005
  • 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 18, 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

  • KUR Research

    Bessemer, Alabama 35022
    United States

    Site Not Available

  • ProSciento, Inc.

    Chula Vista, California 91911
    United States

    Site Not Available

  • Michael Roberts Opthamologist (Eye Exam)

    Glendale, California 91204
    United States

    Site Not Available

  • Eye Treatment Center

    Long Beach, California 90807
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Velocity Clinical Research, Los Angeles

    Los Angeles, California 90017
    United States

    Site Not Available

  • Clinical Innovations, Inc dba CITrials

    Riverside, California 92506
    United States

    Site Not Available

  • Synergy Healthcare

    Bradenton, Florida 34209
    United States

    Site Not Available

  • Miami Eye Institute

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Centers of America

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Site MET097 24-202-001

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • EmVenio Research Centre at PRIME Healthcare

    Riverdale, Georgia 30274
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Koch Family Medicine Clinical Research

    Morton, Illinois 61550
    United States

    Site Not Available

  • Bioluminux Clinical Research

    Naperville, Illinois 60540
    United States

    Site Not Available

  • EmVenio Research Centre at PRIME Healthcare

    Kansas City, Kansas 66112
    United States

    Site Not Available

  • Eagle Eye Care

    Columbia, Maryland 21045
    United States

    Site Not Available

  • KUR Research, LLC

    Columbia, Maryland 21045
    United States

    Site Not Available

  • CBH Health, LLC.

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Emvenio Research

    Garden City, Michigan 48135
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Advocare Berlin Medical Associates

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC (Satellite site)

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • EmVenio Research Centre at PRIME Healthcare

    Farmers Branch, Texas 75234
    United States

    Site Not Available

  • Research Your Health

    Plano, Texas 75093
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Sherman, Texas 75092
    United States

    Site Not Available

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