A Phase 3 interventional study of Berobenatide and Placebo in Obesity, Overweight and Osteoarthritis of the Knee, sponsored by Pfizer. Recruiting at 40 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 656 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo as subcutaneous injection
Other: Placebo
Participants will receive berobenatide by subcutaneous injection.
Drug: Berobenatide
Participants receive berobenatide by subcutaneous injection.
Drug: Berobenatide
Participants receive berobenatide by subcutaneous injection.
Drug: Berobenatide
Subcutaneous Injection
Also known as: PF-08653944, MET097
Subcutaneous Injection
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
Time frame: Baseline and Week 52
Percent change from baseline in Body Weight
Time frame: Baseline and Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein
Time frame: Baseline and Week 52
Change from baseline in WOMAC Physical Function Subscale score
Time frame: Baseline and Week 52
Percentage of participants with ≥50% reduction in the WOMAC pain subscale score
Time frame: Baseline and Week 52
Percentage of participants with ≥30% reduction in the WOMAC pain subscale score
Time frame: Baseline and Week 52
Proportion of participants with utilization of protocol specified pain medication during the washout period
Time frame: Baseline and Week 52
Amount of protocol specified pain medication during the washout period
Time frame: Baseline and Week 52
Change from baseline in WOMAC stiffness score
Time frame: Baseline and Week 52
Change from baseline in WOMAC total score
Time frame: Baseline and Week 52
Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score
Time frame: Baseline and Week 52
Proportion of participants meeting OMERACT-OARSI
Time frame: Baseline and Week 52
Change from baseline in Average Pain Intensity-Numerical Rating Score
Time frame: Baseline and Week 52
Change from baseline in Worst Pain Intensity -Numerical Rating Score
Time frame: Baseline and Week 52
Change from baseline in SF-36 domain scales and component summary scales
Time frame: Baseline and Week 52
Change from baseline in Body Weight
Time frame: Baseline and Week 52
Change from Baseline in Body Mass Index
Time frame: Baseline and Week 52
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline and Week 52
Number of Participants with Serious Adverse Events (SAE)
Time frame: Baseline and Week 52
Number of Participants with AE leading to permanent discontinuation from study intervention or study
Time frame: Baseline and Week 52
Number of Participants with Adverse Events of Special Interest (AESI)
Time frame: Baseline and Week 52
Number of Participants with Clinical laboratory abnormalities
Time frame: Baseline and Week 52
Change from baseline in timed walking distance at Week 52
Time frame: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA related physical function
Time frame: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA pain
Time frame: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) for knee-OA related physical function
Time frame: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change PGI-C for knee-OA pain
Time frame: Baseline and Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Time frame: Baseline and Week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Time frame: Baseline and Week 52
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Time frame: Baseline and Week 52
Change From Baseline in WPAI:GH Work productivity loss score
Time frame: Baseline and Week 52
Change From Baseline in WPAI:GH Activity impairment score
Time frame: Baseline and Week 52
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline and Week 52
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline and Week 52
Change From Baseline in Total Cholesterol
Time frame: Baseline and Week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline and Week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline and Week 52
Change from baseline in Non-HDL Cholesterol
Time frame: Baseline and Week 52
Change from baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Time frame: Baseline and Week 52
Change from baseline in Triglycerides
Time frame: Baseline and Week 52
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Berobenatide