Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

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 is a phase 3, randomized, placebo-controlled trial evaluating the safety and effects of berobenatide given once weekly over 52 weeks in adults with knee osteoarthritis and overweight or obesity, with or without type 2 diabetes. Participants will undergo blood tests, knee pain and function assessments, and body measurements to compare berobenatide with placebo. The study will help determine if berobenatide can improve knee symptoms and body weight in this population. Eligibility includes adults 18 or older with BMI ≥27, radiographic knee OA (Kellgren-Lawrence 2-3), and prior unsuccessful weight-loss efforts.

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.

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.

Where it's running

• Central Alabama Research
  Birmingham, Alabama, United States Recruiting
• Noble Clinical Research, LLC
  Tucson, Arizona, United States Not yet recruiting
• International Research Associates LLC
  Miami, Florida, United States Not yet recruiting
• Carolina Research Center
  Shelby, North Carolina, United States Not yet 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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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.