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ObesityPhase 2VESPER-3NCT06973720

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

A Phase 2 study testing MET097 in people with Obesity and Overweight or Obesity, run by Pfizer at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity, Overweight or Obesity
What is being tested?
MET097
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
268 participants
Where
5 sitesUnited States
Study dates
7 Apr 2025to 16 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body mass index (BMI) at Screening of:
  • BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below)
  • BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the following weight-related co-morbidities:
  • Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
  • Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein 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 women at Screening
  • Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening

Who cannot join

  • Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting 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 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
  • Poorly controlled hypertension at, defined as any of the following:
Show all 10Show fewer
  • Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at Screening visit
  • A change in antihypertensive medications within 30 days of Screening visit
  • Renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension at Screening; postural hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg, with or without symptoms during the assessment, within three minutes of standing
  • Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Research Centers of America

    Hollywood, Florida, 33024

  • Hassman Research Institute

    Marlton, New Jersey, 08053

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • 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 Investigate the Efficacy, Safety and Tolerability of Multiple Dose Regimens of Once-Weekly Switching to Once-Monthly MET097 in Participants With Obesity or Overweight (VESPER-3)

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.

Read the detailed 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.

Being tested
MET097, Placebo
Keywords
Overweight, GLP-1
Medical subject headings
Obesity, Overweight

What participants receive

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

  • MET097Drug

    For subcutaneous administration.

  • PlaceboDrug

    Sterile 0.9% (w/v) saline for subcutaneous administration.

Study groups in NCT06973720
Study groupRoleWhat they receive
MET097ExperimentalParticipants will be randomized to one of four dosing regimens receiving twelve weekly doses of MET097 (with or without titration) followed by multiple monthly doses.
Receives: Drug: MET097
PlaceboPlacebo comparatorParticipants who are randomized to the placebo arm will receive twelve weekly doses of placebo followed by multiple monthly doses.
Receives: Drug: Placebo

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

    Evaluate the efficacy at Week 28 of four dose regimens of QW MET097 switching to QM compared to placebo.

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

Secondary outcomes (14)

  1. Percent change from baseline in body weight at Week 64

    Measured: Baseline (Week 0) through Week 64 (Day 449)

  2. Percent change from baseline in body weight at all other post-baseline weight measurements up to Week 64 other than Week 28

    Measured: Baseline (Week 0) through Week 24 (Day 169); Week 32 (Day 225) through Week 64 (Day 449)

  3. Change from baseline in absolute bodyweight (in kg) at all protocol-specified weekly and monthly post-baseline measurements

    Measured: Baseline (Week 0) through Week 64 (Day 449)

  4. Change from baseline in body mass index (BMI) at all protocol-specified weekly and monthly post-baseline measurements

    Measured: Baseline (Week 0) through Week 64 (Day 449)

  5. Change from baseline in waist circumference (in cm) at all protocol-specified weekly and monthly post-baseline measurements

    Measured: Baseline (Week 0) through Week 64 (Day 449)

  6. Percent change from baseline in body weight at post-treatment follow-up

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  7. Change from baseline in absolute bodyweight (in kg) at post-treatment follow-up

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  8. Change from baseline in body mass index (BMI) at post-treatment follow-up

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  9. Change from baseline in waist circumference (in cm) at post-treatment follow-up

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  10. Occurrence of treatment emergent adverse events (TEAEs)

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  11. Minimum observed concentration (Cmin)

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  12. Area under the concentration versus time curve during the dosing interval (AUC)

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  13. Maximum observed concentration (Cmax)

    Measured: Baseline (Week 0) through Week 72 (Day 505)

  14. Time to maximum concentration (Tmax)

    Measured: Baseline (Week 0) through Week 72 (Day 505)

Timeline

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

  1. First posted15 May 2025
  2. Study start7 Apr 2025
  3. Primary completion16 Dec 2025
  4. Study completion16 Oct 2026 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973720
Sponsor's protocol ID
VESPER-3 (MET097-25-203)
Other IDs
C6491006
Acronym
VESPER-3
Status last verified
Sep 2026
First submitted
6 May 2025
Last updated
24 Sep 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 in people with Obesity and Overweight or Obesity, run by Pfizer at 5 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

This study is still under way. Results are not available in the source record yet.

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 (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 NCT06973720.

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 24 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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