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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Pfizer CT.gov Call Center
- 전화번호: 1-800-718-1021
- 이메일: ClinicalTrials.gov_Inquiries@pfizer.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35209
- 모병
- Central Alabama Research
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Arizona
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Tucson, Arizona, 미국, 85704
- 아직 모집하지 않음
- Noble Clinical Research, LLC
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Florida
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Miami, Florida, 미국, 33183
- 아직 모집하지 않음
- International Research Associates LLC
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North Carolina
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Shelby, North Carolina, 미국, 28150
- 아직 모집하지 않음
- Carolina Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Placebo
Placebo |
Subcutaneous Injection |
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실험적: Arm 1: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
다른 이름들:
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실험적: Arm 2: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
다른 이름들:
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실험적: Arm 3: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
기간: Baseline and Week 52
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Baseline and Week 52
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2차 결과 측정
결과 측정 |
기간 |
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Percent change from baseline in Body Weight
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in High-Sensitivity C-Reactive Protein
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in WOMAC Physical Function Subscale score
기간: Baseline and Week 52
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Baseline and Week 52
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Percentage of participants with ≥50% reduction in the WOMAC pain subscale score
기간: Baseline and Week 52
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Baseline and Week 52
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Percentage of participants with ≥30% reduction in the WOMAC pain subscale score
기간: Baseline and Week 52
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Baseline and Week 52
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Proportion of participants with utilization of protocol specified pain medication during the washout period
기간: Baseline and Week 52
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Baseline and Week 52
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Amount of protocol specified pain medication during the washout period
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in WOMAC stiffness score
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in WOMAC total score
기간: Baseline and Week 52
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Baseline and Week 52
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Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score
기간: Baseline and Week 52
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Baseline and Week 52
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Proportion of participants meeting OMERACT-OARSI
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Average Pain Intensity-Numerical Rating Score
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Worst Pain Intensity -Numerical Rating Score
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in SF-36 domain scales and component summary scales
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Body Weight
기간: Baseline and Week 52
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Baseline and Week 52
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Change from Baseline in Body Mass Index
기간: Baseline and Week 52
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Baseline and Week 52
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Number of participants with Treatment Emergent Adverse Events (TEAEs)
기간: Baseline and Week 52
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Baseline and Week 52
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Number of Participants with Serious Adverse Events (SAE)
기간: Baseline and Week 52
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Baseline and Week 52
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Number of Participants with AE leading to permanent discontinuation from study intervention or study
기간: 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)
기간: Baseline and Week 52
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Baseline and Week 52
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Number of Participants with Clinical laboratory abnormalities
기간: 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
기간: Baseline and Week 52
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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
기간: Baseline and Week 52
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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
기간: Baseline and Week 52
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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
기간: Baseline and Week 52
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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
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in WPAI:GH Presenteeism Score
기간: 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
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in WPAI:GH Activity Impairment Score
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Systolic Blood Pressure (SBP)
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Diastolic Blood Pressure (DBP)
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Total Cholesterol
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
기간: Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Non-HDL Cholesterol
기간: 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
기간: Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Triglycerides
기간: Baseline and Week 52
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Baseline and Week 52
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Change from Baseline in HbA1c (%) (T2D participants only)
기간: Baseline and Week 52
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Baseline and Week 52
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- C6491023
- VESPER-OA 2 (기타 식별자: Alias Study Number)
- 2026-527180-15-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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