756 Participants NeededMy employer runs this trial

Berobenatide for Osteoarthritis

Recruiting at 3 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 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.

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, with or without type 2 diabetes. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I have been diagnosed with knee osteoarthritis by my doctor.
Body mass index of at least 27 kg/m² at Screening
Willingness to complete the required analgesic washout
See 6 more

Exclusion Criteria

I have recently used weight-loss or glucose-lowering medications.
I am allergic to drugs like berobenatide or similar medications.
Self-reported body weight increase or decrease greater than 5% within 90 days before Screening
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Berobenatide

Trial Overview

The study tests a new drug called berobenatide, given once a week by injection, compared to a placebo (inactive treatment) over one year. It looks at effects on knee pain, movement ability, and body weight.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: Berobenatide Once WeeklyExperimental Treatment1 Intervention
Group II: Arm 2: Berobenatide Once WeeklyExperimental Treatment1 Intervention
Group III: Arm 1: Berobenatide Once WeeklyExperimental 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+
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Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

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Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University