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656 Participants NeededMy employer runs this trial

Berobenatide for Knee Arthritis

Recruiting at 39 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults who have knee osteoarthritis and are overweight or obese. Participants should be able to take part in study visits and assessments. People with other major health issues or conditions that could interfere with the study may not be eligible.

Inclusion Criteria

Body mass index of at least 27 kg/m² at Screening
Willingness to complete the required analgesic washout
History of at least 1 self-reported unsuccessful dietary effort to lose body weight
See 4 more

Exclusion Criteria

Significant active or unstable psychiatric disorder
I have recently used weight-loss or glucose-lowering medications.
I or a close family member have had medullary thyroid cancer or MEN2.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Berobenatide

Trial Overview

The study is testing a new medicine called berobenatide against a placebo (inactive treatment) to see if it helps reduce knee pain, improve movement, and support weight loss over one year in people with knee osteoarthritis and excess weight.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: Berobenatide Once MonthlyExperimental Treatment1 Intervention
Group II: Arm 2: Berobenatide Once MonthlyExperimental Treatment1 Intervention
Group III: Arm 1: Berobenatide Once MonthlyExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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