ObesityPhase 3NCT07915609
A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
A Phase 3 study testing Berobenatide in people with Obesity and Overweight and/or Obesity, run by Pfizer at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight and/or Obesity, Knee Osteoarthritis
- What is being tested?
- Berobenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 756 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Oct 2026to 30 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- History of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- HbA1c value at Screening of:
- <6.5% (48 mmol/mol) for participants without T2D
- ≥6.5% (48 mmol/mol) and <10.0% (86 mmol/mol) for participants with T2D
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Central Alabama Research
Birmingham, Alabama, 35209
- Not yet recruiting
International Research Associates LLC
Miami, Florida, 33183
- Not yet recruiting
Carolina Research Center
Shelby, North Carolina, 28150
- Not yet recruiting
Noble Clinical Research, LLC
Tucson, Arizona, 85704
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)
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.
- Being tested
- Berobenatide, Placebo
- Keywords
- Knee Pain, Osteoarthritis, Weight Management, Knee Osteoarthritis, Overweight, Obesity, Type 2 diabetes, Diabetes, GLP1, GLP1 RA, WOMAC, Knee pain, Osteoarthritis, Weight Management, VESPER
- Medical subject headings
- Obesity, Osteoarthritis, Knee, Osteoarthritis, Overweight, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called MET097, PF-08653944
Subcutaneous Injection
PlaceboDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Arm 1: Berobenatide Once Weekly | Experimental | Berobenatide Once Weekly Receives: Drug: Berobenatide |
| Arm 2: Berobenatide Once Weekly | Experimental | Berobenatide Once Weekly Receives: Drug: Berobenatide |
| Arm 3: Berobenatide Once Weekly | Experimental | Berobenatide Once Weekly Receives: Drug: Berobenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
Measured: Baseline and Week 52
Secondary outcomes (41)
Percent change from baseline in Body Weight
Measured: Baseline and Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein
Measured: Baseline and Week 52
Change from baseline in WOMAC Physical Function Subscale score
Measured: Baseline and Week 52
Percentage of participants with ≥50% reduction in the WOMAC pain subscale score
Measured: Baseline and Week 52
Percentage of participants with ≥30% reduction in the WOMAC pain subscale score
Measured: Baseline and Week 52
Proportion of participants with utilization of protocol specified pain medication during the washout period
Measured: Baseline and Week 52
Amount of protocol specified pain medication during the washout period
Measured: Baseline and Week 52
Change from baseline in WOMAC stiffness score
Measured: Baseline and Week 52
Change from baseline in WOMAC total score
Measured: Baseline and Week 52
Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score
Measured: Baseline and Week 52
Proportion of participants meeting OMERACT-OARSI
Measured: Baseline and Week 52
Change from baseline in Average Pain Intensity-Numerical Rating Score
Measured: Baseline and Week 52
Change from baseline in Worst Pain Intensity -Numerical Rating Score
Measured: Baseline and Week 52
Change from baseline in SF-36 domain scales and component summary scales
Measured: Baseline and Week 52
Change from baseline in Body Weight
Measured: Baseline and Week 52
Change from Baseline in Body Mass Index
Measured: Baseline and Week 52
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline and Week 52
Number of Participants with Serious Adverse Events (SAE)
Measured: Baseline and Week 52
Number of Participants with AE leading to permanent discontinuation from study intervention or study
Measured: Baseline and Week 52
Number of Participants with Adverse Events of Special Interest (AESI)
Measured: Baseline and Week 52
Number of Participants with Clinical laboratory abnormalities
Measured: Baseline and Week 52
Change from baseline in timed walking distance at Week 52
Measured: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA related physical function
Measured: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA pain
Measured: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) for knee-OA related physical function
Measured: Baseline and Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change PGI-C for knee-OA pain
Measured: Baseline and Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Measured: Baseline and Week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Measured: Baseline and Week 52
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Measured: Baseline and Week 52
Change From Baseline in WPAI:GH Presenteeism Score
Measured: Baseline and Week 52
Change From Baseline in WPAI:GH Work Productivity Loss Score
Measured: Baseline and Week 52
Change From Baseline in WPAI:GH Activity Impairment Score
Measured: Baseline and Week 52
Change From Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline and Week 52
Change From Baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline and Week 52
Change From Baseline in Total Cholesterol
Measured: Baseline and Week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Measured: Baseline and Week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline and Week 52
Change from baseline in Non-HDL Cholesterol
Measured: Baseline and Week 52
Change from baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Measured: Baseline and Week 52
Change from baseline in Triglycerides
Measured: Baseline and Week 52
Change from Baseline in HbA1c (%) (T2D participants only)
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start26 Oct 2026
- Primary completion21 Aug 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915609
- Sponsor's protocol ID
- C6491023
- Other IDs
- VESPER-OA 2, 2026-527180-15-00
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)
- ClinicalTrials.gov ID
- NCT07915609
- Acronym / sponsor ID
- C6491023
- Keywords
- Knee Pain, Osteoarthritis, Weight Management, Knee Osteoarthritis, Overweight, Obesity, Type 2 diabetes, Diabetes, GLP1, GLP1 RA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 21 Aug 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Arm 1: Berobenatide Once Weekly | Experimental | Drug: BerobenatideBerobenatide Once Weekly |
| Arm 2: Berobenatide Once Weekly | Experimental | Drug: BerobenatideBerobenatide Once Weekly |
| Arm 3: Berobenatide Once Weekly | Experimental | Drug: BerobenatideBerobenatide Once Weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
- For participants with T2D at Screening only:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerobenatideAlso: MET097, PF-08653944Subcutaneous Injection | Drug | Arm 1: Berobenatide Once Weekly, Arm 2: Berobenatide Once Weekly, Arm 3: Berobenatide Once Weekly |
| PlaceboSubcutaneous Injection | Drug | Placebo |
Primary outcome
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
Time frame: Baseline and Week 52
41 secondary outcomes
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 Presenteeism 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Berobenatide in people with Obesity and Overweight and/or Obesity, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.