Berobenatide for knee pain in adults who are overweight or with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial examines the safety and effects of berobenatide (PF-08653944) in adults with knee osteoarthritis and overweight or obesity over 52 weeks. Participants are randomized to receive berobenatide or placebo and will undergo blood tests, knee pain assessments, physical function questionnaires, and body measurements. Eligibility includes adults 18 or older with BMI ≥27, radiographic evidence of knee OA (Kellgren-Lawrence grade 2–3), and a history of unsuccessful weight-loss attempts. Key exclusions include diabetes, certain pancreatic or gallbladder conditions, and specific thyroid cancer risks. The study is sponsored by Pfizer and conducted at multiple sites in California and Arizona.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria

* Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
* History of diabetes or Screening laboratory findings indicative of diabetes.
* 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.

Where it's running

• Universal Axon Clinical Research LLC
  Doral, Florida, United States Recruiting
• Profound Research LLC
  Farmington Hills, Michigan, United States Recruiting
• Revive Research Institute, Inc.
  Sterling Heights, Michigan, United States Recruiting
• Monroe Biomedical Research
  Monroe, North Carolina, United States Recruiting
• Accellacare
  Wilmington, North Carolina, United States Recruiting
• Delaney Radiologist
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.