A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)

October 30, 2026 updated by: Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)

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 with and without type 2 diabetes. 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.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
756

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 3

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
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Central Alabama Research
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Not yet recruiting
        • Noble Clinical Research, LLC
    • Florida
      • Miami, Florida, United States, 33183
        • Not yet recruiting
        • International Research Associates LLC
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Not yet recruiting
        • Carolina Research Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

HbA1c value at Screening of:

  1. <6.5% (48 mmol/mol) for participants without T2D
  2. ≥6.5% (48 mmol/mol) and <10.0% (86 mmol/mol) for participants with T2D

Exclusion Criteria

  • Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.

  • For participants with T2D at Screening only:

    • Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention

  • 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

  • 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.

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: Quadruple

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

Placebo
Drug: Placebo

Subcutaneous Injection
Experimental: Arm 1: Berobenatide Once Weekly

Berobenatide Once Weekly
Drug: Berobenatide

Subcutaneous Injection

Other Names:
  • PF-08653944
  • MET097
Experimental: Arm 2: Berobenatide Once Weekly

Berobenatide Once Weekly
Drug: Berobenatide

Subcutaneous Injection

Other Names:
  • PF-08653944
  • MET097
Experimental: Arm 3: Berobenatide Once Weekly

Berobenatide Once Weekly
Drug: Berobenatide

Subcutaneous Injection

Other Names:
  • PF-08653944
  • MET097

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
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
Time Frame: Baseline and Week 52
Baseline and Week 52

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
Time Frame
Percent change from baseline in Body Weight
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in WOMAC Physical Function Subscale score
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of participants with ≥50% reduction in the WOMAC pain subscale score
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of participants with ≥30% reduction in the WOMAC pain subscale score
Time Frame: Baseline and Week 52
Baseline and Week 52
Proportion of participants with utilization of protocol specified pain medication during the washout period
Time Frame: Baseline and Week 52
Baseline and Week 52
Amount of protocol specified pain medication during the washout period
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in WOMAC stiffness score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in WOMAC total score
Time Frame: Baseline and Week 52
Baseline and Week 52
Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score
Time Frame: Baseline and Week 52
Baseline and Week 52
Proportion of participants meeting OMERACT-OARSI
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in Average Pain Intensity-Numerical Rating Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in Worst Pain Intensity -Numerical Rating Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in SF-36 domain scales and component summary scales
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in Body Weight
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Body Mass Index
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants with Serious Adverse Events (SAE)
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants with AE leading to permanent discontinuation from study intervention or study
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants with Adverse Events of Special Interest (AESI)
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants with Clinical laboratory abnormalities
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in timed walking distance at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA related physical function
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA pain
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) for knee-OA related physical function
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change PGI-C for knee-OA pain
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in WPAI:GH Presenteeism Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in WPAI:GH Work Productivity Loss Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in WPAI:GH Activity Impairment Score
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in Total Cholesterol
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in Non-HDL Cholesterol
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from baseline in Triglycerides
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in HbA1c (%) (T2D participants only)
Time Frame: Baseline and Week 52
Baseline and Week 52

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.
October 26, 2026

Primary Completion (Estimated)

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.
August 21, 2028

Study Completion (Estimated)

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.
October 30, 2028

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).
October 20, 2026

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.
October 30, 2026

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.
November 4, 2026

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.
November 4, 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.
October 30, 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.
October 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.
  • C6491023
  • VESPER-OA 2 (Other Identifier: Alias Study Number)
  • 2026-527180-15-00 (Registry Identifier: CTIS (EU))

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

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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