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, 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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Berobenatide (drug)
- Placebo (drug)
Sponsor: Pfizer · Participants: 756 · Started: Oct 26, 2026
Contact the study team
- Pfizer CT.gov Call Center · Phone: 1-800-718-1021
Official record on ClinicalTrials.gov — NCT07915609
Locations in the U.S.
| Alabama | Central Alabama Research, Birmingham |
| Arizona | Noble Clinical Research, LLC, Tucson (Not yet recruiting) |
| Florida | International Research Associates LLC, Miami (Not yet recruiting) |
| North Carolina | Carolina Research Center, Shelby (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.