Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
656 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults with knee pain who are overweight or have obesity. Participants will receive either the study medicine berobenatide or a placebo for a year to see how it affects their knee pain and weight.
Are You a Good Fit for This Trial?
Rules you outDiabetesPancreatitisGastric-emptying abnormalityMedullary thyroid carcinomaSignificant psychiatric disorder
You may be able to join if
I am at least 18 years old.
I have a body mass index of at least 27.
I have been diagnosed with knee osteoarthritis.
I experience pain in my knee.
I have a knee x-ray showing signs of osteoarthritis.
I am willing to stop taking certain pain medications before the study.
I have tried to lose weight before but was not successful.
You may not be able to join if
I have gained or lost more than 5% of my weight in the last 90 days.
I have a history of diabetes.
I have issues with how my stomach empties.
I have a personal or family history of medullary thyroid carcinoma.
I have a serious or unstable mental health condition.
I have a condition that may affect my knee pain assessment.
I am scheduled for knee surgery during the study.
I have participated in a berobenatide study before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. 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 fu…
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. 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.
Trial Locations
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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 consisten…
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.
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