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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

756

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Pfizer

Investigators

  • 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)

October 26, 2026

Primary Completion (Estimated)

August 21, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

October 20, 2026

First Submitted That Met QC Criteria

October 30, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 30, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Subscribe