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, 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
- Rekruttering
- Central Alabama Research
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Arizona
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Tucson, Arizona, Forenede Stater, 85704
- Ikke rekrutterer endnu
- Noble Clinical Research, LLC
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Florida
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Miami, Florida, Forenede Stater, 33183
- Ikke rekrutterer endnu
- International Research Associates LLC
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North Carolina
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Shelby, North Carolina, Forenede Stater, 28150
- Ikke rekrutterer endnu
- Carolina Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
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
Exclusion Criteria
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Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
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For participants with T2D at Screening only:
• Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention
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Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.
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Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
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Significant active or unstable psychiatric disorder.
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Condition or knee disorder that could confound assessment of target-knee pain
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Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.
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Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.
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Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.
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Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo |
Subcutaneous Injection |
|
Eksperimentel: Arm 1: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
Andre navne:
|
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Eksperimentel: Arm 2: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
Andre navne:
|
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Eksperimentel: Arm 3: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent change from baseline in Body Weight
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Change from baseline in WOMAC Physical Function Subscale score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of participants with ≥50% reduction in the WOMAC pain subscale score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of participants with ≥30% reduction in the WOMAC pain subscale score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Proportion of participants with utilization of protocol specified pain medication during the washout period
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Amount of protocol specified pain medication during the washout period
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in WOMAC stiffness score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in WOMAC total score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Proportion of participants meeting OMERACT-OARSI
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Average Pain Intensity-Numerical Rating Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Worst Pain Intensity -Numerical Rating Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Change from baseline in SF-36 domain scales and component summary scales
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Body Weight
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Change from Baseline in Body Mass Index
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Number of Participants with Serious Adverse Events (SAE)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Number of Participants with AE leading to permanent discontinuation from study intervention or study
Tidsramme: Baseline and Week 52
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Baseline and Week 52
|
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Number of Participants with Adverse Events of Special Interest (AESI)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Number of Participants with Clinical laboratory abnormalities
Tidsramme: Baseline and Week 52
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Baseline and Week 52
|
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Change from baseline in timed walking distance at Week 52
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA related physical function
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA pain
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) for knee-OA related physical function
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change PGI-C for knee-OA pain
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
|
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in WPAI:GH Presenteeism Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in WPAI:GH Work Productivity Loss Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in WPAI:GH Activity Impairment Score
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in Systolic Blood Pressure (SBP)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in Diastolic Blood Pressure (DBP)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in Total Cholesterol
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Non-HDL Cholesterol
Tidsramme: Baseline and Week 52
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Baseline and Week 52
|
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Change from baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Triglycerides
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
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Change from Baseline in HbA1c (%) (T2D participants only)
Tidsramme: Baseline and Week 52
|
Baseline and Week 52
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Muskuloskeletale sygdomme
- Ernæringsforstyrrelser
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Glukosemetabolismeforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Diabetes mellitus, type 2
- Slidgigt
- Slidgigt, knæ
- Diabetes mellitus
Andre undersøgelses-id-numre
- C6491023
- VESPER-OA 2 (Anden identifikator: Alias Study Number)
- 2026-527180-15-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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