A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM (VESPER-2)

June 11, 2026 updated by: Pfizer

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Bessemer, Alabama, United States, 35022
        • KUR Research
    • California
      • Chula Vista, California, United States, 91911
        • ProSciento, Inc.
      • Glendale, California, United States, 91204
        • Michael Roberts Opthamologist (Eye Exam)
      • Long Beach, California, United States, 90807
        • Eye Treatment Center
      • Los Alamitos, California, United States, 90720
        • Collaborative Neuroscience Research, LLC
      • Los Angeles, California, United States, 90017
        • Velocity Clinical Research, Los Angeles
      • Riverside, California, United States, 92506
        • Clinical Innovations, Inc dba CITrials
    • Florida
      • Bradenton, Florida, United States, 34209
        • Synergy Healthcare
      • Hollywood, Florida, United States, 33024
        • Research Centers of America
      • Hollywood, Florida, United States, 33024
        • Miami Eye Institute
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Georgia
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC
      • Riverdale, Georgia, United States, 30274
        • EmVenio Research Centre at PRIME Healthcare
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch, LLC
    • Illinois
      • Morton, Illinois, United States, 61550
        • Koch Family Medicine Clinical Research
      • Naperville, Illinois, United States, 60540
        • Bioluminux Clinical Research
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • EmVenio Research Centre at PRIME Healthcare
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Eagle Eye Care
      • Columbia, Maryland, United States, 21045
        • Kur Research, LLC
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health, LLC.
    • Michigan
      • Garden City, Michigan, United States, 48135
        • EmVenio Research
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Advocare Berlin Medical Associates
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • OnSite Clinical Solutions, LLC
      • Charlotte, North Carolina, United States, 28277
        • Onsite Clinical Solutions, LLC (Satellite site)
    • Texas
      • Farmers Branch, Texas, United States, 75234
        • EmVenio Research Centre at PRIME Healthcare
      • Plano, Texas, United States, 75093
        • Research Your Health
      • Sherman, Texas, United States, 75092
        • Revival Research Institute, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
  • Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening

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 or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
  • Diagnosis of Type 1 diabetes (history of ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM)
  • History of acute or chronic pancreatitis
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of significant active or unstable major depressive disorder (MDD) or other severe 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
Experimental: MET097 Active with titration
Drug: MET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
Experimental: MET097 Active without titration
Drug: MET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent change from baseline in body weight at Week 28 (Day 197)
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight reduction (weight loss) from baseline that is ≥ 5%
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 10%
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 15%
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Change in glycated hemoglobin A1c (HbA1c)
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in fasting plasma glucose (FPG)
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in fasting serum insulin
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in C-peptide
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Occurrence of HbA1c <7.0% (53.0 mmol/mol)
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Occurrence of HbA1c ≤6.5% (47.5 mmol/mol)
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Occurrence of HbA1c <5.7% (38.8 mmol/mol)
Time Frame: Baseline (Week 0) through Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Occurrence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Treatment emergent adverse events include adverse events of clinical interest as well as abnormal clinical significant physical exams, laboratory findings, and 12-lead ECG measurements that meet the definition for an AE.
Baseline (Week 0) through Week 39 (Day 274)
Occurrence of hypoglycemia according to American Diabetes Association classifications [ADA 2024]
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Occurrence of anti-drug antibodies
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Change from baseline in serum albumin
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Change from baseline in transthyretin [pre-albumin]
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Change from baseline in high-sensitivity C-reactive Protein [hsCRP]
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Characterize the minimum observed concentration (Cmin)
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Characterize the maximum observed concentration (Cmax)
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Characterize the area under the concentration versus time curve (AUC)
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)
Characterize the time to maximum concentration (Tmax)
Time Frame: Baseline (Week 0) through Week 39 (Day 274)
Baseline (Week 0) through Week 39 (Day 274)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VESPER-2 (MET097-24-202)
  • C6491005 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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