NCT07915609 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)
| NCT ID | NCT07915609 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 756 participants |
| Start Date | 2026-10-26 |
| Primary Completion | 2028-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 756 participants in total. It began in 2026-10-26 with a primary completion date of 2028-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07915609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07915609 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 756 participants.
Is NCT07915609 currently recruiting?
Yes, NCT07915609 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07915609 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, Miami, United States, Shelby, United States.
Who is sponsoring the NCT07915609 clinical trial?
NCT07915609 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 756 participants.
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