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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35209
- Recrutement
- Central Alabama Research
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Arizona
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Tucson, Arizona, États-Unis, 85704
- Pas encore de recrutement
- Noble Clinical Research, LLC
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Florida
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Miami, Florida, États-Unis, 33183
- Pas encore de recrutement
- International Research Associates LLC
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North Carolina
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Shelby, North Carolina, États-Unis, 28150
- Pas encore de recrutement
- Carolina Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
Placebo |
Subcutaneous Injection |
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Expérimental: Arm 1: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
Autres noms:
|
|
Expérimental: Arm 2: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
Autres noms:
|
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Expérimental: Arm 3: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percent change from baseline in Body Weight
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Change from baseline in WOMAC Physical Function Subscale score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of participants with ≥50% reduction in the WOMAC pain subscale score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Percentage of participants with ≥30% reduction in the WOMAC pain subscale score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Proportion of participants with utilization of protocol specified pain medication during the washout period
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Amount of protocol specified pain medication during the washout period
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Change from baseline in WOMAC stiffness score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in WOMAC total score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Proportion of participants meeting OMERACT-OARSI
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Average Pain Intensity-Numerical Rating Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Worst Pain Intensity -Numerical Rating Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in SF-36 domain scales and component summary scales
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from baseline in Body Weight
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from Baseline in Body Mass Index
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Number of Participants with Serious Adverse Events (SAE)
Délai: 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
Délai: 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)
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Number of Participants with Clinical laboratory abnormalities
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Change from baseline in timed walking distance at Week 52
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and Week 52
|
Baseline and Week 52
|
|
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in WPAI:GH Presenteeism Score
Délai: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in WPAI:GH Work Productivity Loss Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in WPAI:GH Activity Impairment Score
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change From Baseline in Systolic Blood Pressure (SBP)
Délai: Baseline and Week 52
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Baseline and Week 52
|
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Change From Baseline in Diastolic Blood Pressure (DBP)
Délai: Baseline and Week 52
|
Baseline and Week 52
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Change From Baseline in Total Cholesterol
Délai: Baseline and Week 52
|
Baseline and Week 52
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Délai: Baseline and Week 52
|
Baseline and Week 52
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Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Délai: Baseline and Week 52
|
Baseline and Week 52
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Change from baseline in Non-HDL Cholesterol
Délai: 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
Délai: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Triglycerides
Délai: Baseline and Week 52
|
Baseline and Week 52
|
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Change from Baseline in HbA1c (%) (T2D participants only)
Délai: Baseline and Week 52
|
Baseline and Week 52
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies musculo-squelettiques
- Troubles nutritionnels
- Arthrite
- Maladies articulaires
- Maladies rhumatismales
- Maladies métaboliques
- Suralimentation
- Poids
- Troubles du métabolisme du glucose
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- En surpoids
- Obésité
- Diabète sucré, Type 2
- Arthrose
- Arthrose, Genou
- Diabète sucré
Autres numéros d'identification d'étude
- C6491023
- VESPER-OA 2 (Autre identifiant: Alias Study Number)
- 2026-527180-15-00 (Identificateur de registre: CTIS (EU))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .