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RecruitingNCT07915609Updated Nov 4, 2026

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)

A Phase 3 interventional study of Berobenatide and Placebo in Obesity, Overweight and/or Obesity and Knee Osteoarthritis, sponsored by Pfizer. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
756
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity
  • Overweight and/or Obesity
  • Knee Osteoarthritis
  • Diabetes Melliuts, Type 2

Keywords

  • Knee Pain, Osteoarthritis, Weight Management
  • Knee Osteoarthritis
  • Overweight
  • Obesity
  • Type 2 diabetes
  • Diabetes
  • GLP1
  • GLP1 RA
  • WOMAC
  • Knee pain
  • Osteoarthritis
  • Weight Management
  • VESPER
03

In context

Obesity

6,616 studies on the registry are indexed under Obesity; 1,726 are open to participants now.

This study's planned enrollment of 756 is above the median of 77 across 5,121 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Pfizer is the lead sponsor of 3,331 studies on the registry; 148 are open to participants now.

Of its 600 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
756 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Experimental
    Arm 1: Berobenatide Once Weekly

    Berobenatide Once Weekly

    Drug: Berobenatide

  • Experimental
    Arm 2: Berobenatide Once Weekly

    Berobenatide Once Weekly

    Drug: Berobenatide

  • Experimental
    Arm 3: Berobenatide Once Weekly

    Berobenatide Once Weekly

    Drug: Berobenatide

Interventions

  • DrugBerobenatide

    Subcutaneous Injection

    Also known as: MET097, PF-08653944

  • DrugPlacebo

    Subcutaneous Injection

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline and Week 52

Secondary outcomes

  1. Percent change from baseline in Body Weight

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  3. Change from baseline in WOMAC Physical Function Subscale score

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  8. Change from baseline in WOMAC stiffness score

    Time frame: Baseline and Week 52

  9. Change from baseline in WOMAC total score

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  11. Proportion of participants meeting OMERACT-OARSI

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  15. Change from baseline in Body Weight

    Time frame: Baseline and Week 52

  16. Change from Baseline in Body Mass Index

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  21. Number of Participants with Clinical laboratory abnormalities

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  23. 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

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

    Time frame: Baseline and Week 52

  25. 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

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  30. Change From Baseline in WPAI:GH Presenteeism Score

    Time frame: Baseline and Week 52

  31. Change From Baseline in WPAI:GH Work Productivity Loss Score

    Time frame: Baseline and Week 52

  32. Change From Baseline in WPAI:GH Activity Impairment Score

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  35. Change From Baseline in Total Cholesterol

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  38. Change from baseline in Non-HDL Cholesterol

    Time frame: Baseline and Week 52

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

    Time frame: Baseline and Week 52

  40. Change from baseline in Triglycerides

    Time frame: Baseline and Week 52

  41. Change from Baseline in HbA1c (%) (T2D participants only)

    Time frame: Baseline and Week 52

07

Study locations

1 of 4 sites recruiting
  • Central Alabama Research
    Birmingham, Alabama 35209, United States
    Recruiting
    + New studies here

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  • Noble Clinical Research, LLC
    Tucson, Arizona 85704, United States
    Not yet recruiting
    + New studies here

    Other open studies at Noble Clinical Research, LLC, Tucson

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  • International Research Associates LLC
    Miami, Florida 33183, United States
    Not yet recruiting
    + New studies here

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  • Carolina Research Center
    Shelby, North Carolina 28150, United States
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · www.pfizer.com

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07915609
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Oct 26, 2026
Primary completion
Aug 21, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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