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ObesityPhase 3NCT07919678

A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)

A Phase 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 40 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight, Osteoarthritis of the Knee
What is being tested?
Berobenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
656 participants
Where
40 sitesin 2 countries
Study dates
26 Oct 2026to 10 Oct 2028
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults 18 years of age or older, or the minimum age of consent according to local regulations.
  • Body mass index of at least 27 kg/m² at Screening.
  • Currently meets American College of Rheumatology (ACR) Criteria for knee OA.
  • Pain due to knee OA.
  • Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3.
  • Willingness to complete the required analgesic washout.
  • History of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Who cannot join

  • Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
  • History of diabetes or Screening laboratory findings indicative of diabetes.
  • Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.
  • Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
  • Significant active or unstable psychiatric disorder.
  • Condition or knee disorder that could confound assessment of target-knee pain.
Show all 10Show fewer
  • Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.
  • Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.
  • Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.
  • Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.

Trial locations and contacts

40 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

40 sites in 2 countries

United States39 sites, 39 recruiting
  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

    Not yet recruiting
  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

    Not yet recruiting
  • Northwestern Medicine

    Chicago, Illinois, 60611

    Not yet recruiting
  • Northwestern Memorial Hospital, Diagnostic Testing Center (Phlebotomy/EKG)

    Chicago, Illinois, 60611

    Not yet recruiting
  • Northwestern Memorial Hospital, Investigational Drug Service

    Chicago, Illinois, 60611

    Not yet recruiting
  • Northwestern University Feinberg School Of Medicine

    Chicago, Illinois, 60611

    Not yet recruiting
  • Great Lakes Clinical Trials, LLC dba Flourish Research

    Chicago, Illinois, 60640

    Not yet recruiting
  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

    Not yet recruiting
  • Skylight Health Research

    Colorado Springs, Colorado, 80917

    Not yet recruiting
  • Mercy Family Clinic

    Dallas, Texas, 75208

    Not yet recruiting
  • Universal Axon Clinical Research LLC

    Doral, Florida, 33166

    Recruiting
  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

    Recruiting
  • Headlands Research California, LLC

    Escondido, California, 92025

    Not yet recruiting
  • Profound Research LLC

    Farmington Hills, Michigan, 48334

    Recruiting
  • Cedar Health Research

    Fort Worth, Texas, 76132

    Not yet recruiting
  • Novant Health Granite Quarry Internal Medicine (knee x-ray)

    Granite Quarry, North Carolina, 28146

    Not yet recruiting
  • BRCR Global Louisiana

    Gretna, Louisiana, 70053

    Not yet recruiting
  • JCCT-JUNO NW Houston

    Houston, Texas, 77040

    Not yet recruiting
  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

    Not yet recruiting
  • Activian Clinical Research

    Kingwood, Texas, 77339

    Not yet recruiting
  • Renstar Medical Research

    Lady Lake, Florida, 32159

    Not yet recruiting
  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

    Recruiting
  • AMR Clinical

    Norman, Oklahoma, 73069

    Not yet recruiting
  • Renstar Medical Research

    Ocala, Florida, 34470

    Not yet recruiting
  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730

    Not yet recruiting
  • Accellacare - Salisbury

    Salisbury, North Carolina, 28144

    Not yet recruiting
  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

    Not yet recruiting
  • Revive Research Institute, Inc.

    Sterling Heights, Michigan, 48313

    Recruiting
  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

    Not yet recruiting
  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

    Not yet recruiting
  • AMR Clinical

    Tempe, Arizona, 85281

    Not yet recruiting
  • DM Clinical Research

    Tomball, Texas, 77375

    Not yet recruiting
  • Solace Clinical Research

    Tustin, California, 92780

    Not yet recruiting
  • Velocity Clinical Research, Waco

    Waco, Texas, 76710

    Not yet recruiting
  • Elevate Clinical Research

    Wichita, Kansas, 67214

    Not yet recruiting
  • Accellacare

    Wilmington, North Carolina, 28401

    Recruiting
  • Delaney Radiologist

    Wilmington, North Carolina, 28401

    Recruiting
  • North Georgia Clinical Research, LLC

    Woodstock, Georgia, 30189

    Not yet recruiting
  • North Georgia Internal Medicine

    Woodstock, Georgia, 30189

    Not yet recruiting

Other trials in United States

Canada1 site, 1 recruiting
  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

    Not yet recruiting

Other trials in Canada

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY (VESPER-OA 1)

The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity. The study will last 52 weeks and compare the effects of berobenatide compared to placebo on knee pain, physical function, and body weight. Study activities will include blood tests, knee pain assessment, physical function questionnaires and body measurements.

Being tested
Berobenatide, Placebo
Keywords
Knee Pain, Osteoarthritis, Weight Management, Knee Osteoarthritis, Obesity, Overweight, GLP1, GLP1-RA, WOMAC
Medical subject headings
Obesity, Overweight, Osteoarthritis, Knee, Osteoarthritis

What participants receive

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

  • BerobenatideDrug

    Also called PF-08653944, MET097

    Subcutaneous Injection

  • PlaceboOther

    Subcutaneous Injection

Study groups in NCT07919678
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo as subcutaneous injection
Receives: Other: Placebo
Arm 1: Berobenatide Once MonthlyExperimentalParticipants will receive berobenatide by subcutaneous injection.
Receives: Drug: Berobenatide
Arm 2: Berobenatide Once MonthlyExperimentalParticipants receive berobenatide by subcutaneous injection.
Receives: Drug: Berobenatide
Arm 3: Berobenatide Once MonthlyExperimentalParticipants receive berobenatide by subcutaneous injection.
Receives: Drug: Berobenatide

What is being measured

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

  1. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score

    Measured: Baseline and Week 52

Secondary outcomes (39)
  1. Percent change from baseline in Body Weight

    Measured: Baseline and Week 52

  2. Change From Baseline in High-Sensitivity C-Reactive Protein

    Measured: Baseline and Week 52

  3. Change from baseline in WOMAC Physical Function Subscale score

    Measured: Baseline and Week 52

  4. Percentage of participants with ≥50% reduction in the WOMAC pain subscale score

    Measured: Baseline and Week 52

  5. Percentage of participants with ≥30% reduction in the WOMAC pain subscale score

    Measured: Baseline and Week 52

  6. Proportion of participants with utilization of protocol specified pain medication during the washout period

    Measured: Baseline and Week 52

  7. Amount of protocol specified pain medication during the washout period

    Measured: Baseline and Week 52

  8. Change from baseline in WOMAC stiffness score

    Measured: Baseline and Week 52

  9. Change from baseline in WOMAC total score

    Measured: Baseline and Week 52

  10. Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score

    Measured: Baseline and Week 52

  11. Proportion of participants meeting OMERACT-OARSI

    Measured: Baseline and Week 52

  12. Change from baseline in Average Pain Intensity-Numerical Rating Score

    Measured: Baseline and Week 52

  13. Change from baseline in Worst Pain Intensity -Numerical Rating Score

    Measured: Baseline and Week 52

  14. Change from baseline in SF-36 domain scales and component summary scales

    Measured: Baseline and Week 52

  15. Change from baseline in Body Weight

    Measured: Baseline and Week 52

  16. Change from Baseline in Body Mass Index

    Measured: Baseline and Week 52

  17. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Baseline and Week 52

  18. Number of Participants with Serious Adverse Events (SAE)

    Measured: Baseline and Week 52

  19. Number of Participants with AE leading to permanent discontinuation from study intervention or study

    Measured: Baseline and Week 52

  20. Number of Participants with Adverse Events of Special Interest (AESI)

    Measured: Baseline and Week 52

  21. Number of Participants with Clinical laboratory abnormalities

    Measured: Baseline and Week 52

  22. Change from baseline in timed walking distance at Week 52

    Measured: Baseline and Week 52

  23. Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA related physical function

    Measured: Baseline and Week 52

  24. Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA pain

    Measured: Baseline and Week 52

  25. Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) for knee-OA related physical function

    Measured: Baseline and Week 52

  26. Percentage of Participants Reporting Improvement in Patient Global Impression of Change PGI-C for knee-OA pain

    Measured: Baseline and Week 52

  27. Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score

    Measured: Baseline and Week 52

  28. Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score

    Measured: Baseline and Week 52

  29. Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score

    Measured: Baseline and Week 52

  30. Change From Baseline in WPAI:GH Work productivity loss score

    Measured: Baseline and Week 52

  31. Change From Baseline in WPAI:GH Activity impairment score

    Measured: Baseline and Week 52

  32. Change From Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline and Week 52

  33. Change From Baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline and Week 52

  34. Change From Baseline in Total Cholesterol

    Measured: Baseline and Week 52

  35. Change From Baseline in High-density lipoprotein cholesterol (HDL-C)

    Measured: Baseline and Week 52

  36. Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)

    Measured: Baseline and Week 52

  37. Change from baseline in Non-HDL Cholesterol

    Measured: Baseline and Week 52

  38. Change from baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol

    Measured: Baseline and Week 52

  39. Change from baseline in Triglycerides

    Measured: Baseline and Week 52

Timeline

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

  1. First posted5 Nov 2026
  2. Study start26 Oct 2026
  3. Primary completion22 Aug 2028 (estimated)
  4. Study completion10 Oct 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
656 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919678
Sponsor's protocol ID
C6491022
Other IDs
Vesper-OA 1, 2026-526328-34-00
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
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 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 40 sites in 2 countries.

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 7 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2026.

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