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Obesity in DiabetesPhase 2VESPER-2NCT06897202

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

A Phase 2 study testing MET097 Injection in people with Obesity in Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Pfizer at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MET097 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
29 sitesUnited States
Study dates
14 Mar 2025to 18 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Advocare Berlin Medical Associates

    Berlin, New Jersey, 08009

  • KUR Research

    Bessemer, Alabama, 35022

  • Synergy Healthcare

    Bradenton, Florida, 34209

  • Onsite Clinical Solutions, LLC (Satellite site)

    Charlotte, North Carolina, 28277

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina, 28277

  • ProSciento, Inc.

    Chula Vista, California, 91911

  • Eagle Eye Care

    Columbia, Maryland, 21045

  • KUR Research, LLC

    Columbia, Maryland, 21045

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

  • EmVenio Research Centre at PRIME Healthcare

    Farmers Branch, Texas, 75234

  • CBH Health, LLC.

    Gaithersburg, Maryland, 20877

  • Emvenio Research

    Garden City, Michigan, 48135

  • Michael Roberts Opthamologist (Eye Exam)

    Glendale, California, 91204

  • Miami Eye Institute

    Hollywood, Florida, 33024

  • Research Centers of America

    Hollywood, Florida, 33024

  • EmVenio Research Centre at PRIME Healthcare

    Kansas City, Kansas, 66112

  • Eye Treatment Center

    Long Beach, California, 90807

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

  • Velocity Clinical Research, Los Angeles

    Los Angeles, California, 90017

  • Hassman Research Institute

    Marlton, New Jersey, 08053

  • Koch Family Medicine Clinical Research

    Morton, Illinois, 61550

  • Bioluminux Clinical Research

    Naperville, Illinois, 60540

  • Velocity Clinical Research

    Omaha, Nebraska, 68134

  • Research Your Health

    Plano, Texas, 75093

  • EmVenio Research Centre at PRIME Healthcare

    Riverdale, Georgia, 30274

  • Clinical Innovations, Inc dba CITrials

    Riverside, California, 92506

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • Revival Research Institute, LLC

    Sherman, Texas, 75092

  • ForCare Clinical Research

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
MET097 Injection, Placebo
Keywords
GLP-1, Metsera, T2DM, Obesity, Overweight, Weight Loss
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MET097 InjectionDrug

    MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.

  • PlaceboDrug

    Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Study groups in NCT06897202
Study groupRoleWhat they receive
MET097 Active with titrationExperimentalNot described
Receives: Drug: MET097 Injection
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
MET097 Active without titrationExperimentalNot described
Receives: Drug: MET097 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in body weight at Week 28 (Day 197)

    Measured: Baseline (Week 0) through Week 28 (Day 197)

Secondary outcomes (20)

  1. Weight reduction (weight loss) from baseline that is ≥ 5%

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  2. Weight reduction (weight loss) from baseline that is ≥ 10%

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  3. Weight reduction (weight loss) from baseline that is ≥ 15%

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  4. Change in glycated hemoglobin A1c (HbA1c)

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  5. Change from baseline in fasting plasma glucose (FPG)

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  6. Change from baseline in fasting serum insulin

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  7. Change from baseline in C-peptide

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  8. Occurrence of HbA1c <7.0% (53.0 mmol/mol)

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  9. Occurrence of HbA1c ≤6.5% (47.5 mmol/mol)

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  10. Occurrence of HbA1c <5.7% (38.8 mmol/mol)

    Measured: Baseline (Week 0) through Week 28 (Day 197)

  11. Occurrence of treatment-emergent adverse events (TEAEs)

    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.

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  12. Occurrence of hypoglycemia according to American Diabetes Association classifications [ADA 2024]

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  13. Occurrence of anti-drug antibodies

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  14. Change from baseline in serum albumin

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  15. Change from baseline in transthyretin [pre-albumin]

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  16. Change from baseline in high-sensitivity C-reactive Protein [hsCRP]

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  17. Characterize the minimum observed concentration (Cmin)

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  18. Characterize the maximum observed concentration (Cmax)

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  19. Characterize the area under the concentration versus time curve (AUC)

    Measured: Baseline (Week 0) through Week 39 (Day 274)

  20. Characterize the time to maximum concentration (Tmax)

    Measured: Baseline (Week 0) through Week 39 (Day 274)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2025
  2. Study start14 Mar 2025
  3. Primary completion29 Dec 2025
  4. Study completion18 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06897202
Sponsor's protocol ID
VESPER-2 (MET097-24-202)
Other IDs
C6491005
Acronym
VESPER-2
Status last verified
Jun 2026
First submitted
13 Mar 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MET097 Injection in people with Obesity in Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Pfizer at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in body weight at Week 28 (Day 197) (time frame: Baseline (Week 0) through Week 28 (Day 197)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06897202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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