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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Pfizer CT.gov Call Center
- 電話番号：1-800-718-1021
- メール：ClinicalTrials.gov_Inquiries@pfizer.com
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35209
- 募集
- Central Alabama Research
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Arizona
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Tucson、Arizona、アメリカ、85704
- まだ募集していません
- Noble Clinical Research, LLC
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Florida
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Miami、Florida、アメリカ、33183
- まだ募集していません
- International Research Associates LLC
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North Carolina
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Shelby、North Carolina、アメリカ、28150
- まだ募集していません
- Carolina Research Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Placebo
Placebo |
Subcutaneous Injection |
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実験的：Arm 1: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
他の名前：
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実験的：Arm 2: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
他の名前：
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実験的：Arm 3: Berobenatide Once Weekly
Berobenatide Once Weekly |
Subcutaneous Injection
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score
時間枠：Baseline and Week 52
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Baseline and Week 52
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Percent change from baseline in Body Weight
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from baseline in WOMAC stiffness score
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from baseline in WOMAC total score
時間枠：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
時間枠：Baseline and Week 52
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Baseline and Week 52
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Proportion of participants meeting OMERACT-OARSI
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Body Weight
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from Baseline in Body Mass Index
時間枠：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)
時間枠：Baseline and Week 52
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Baseline and Week 52
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Number of Participants with Serious Adverse Events (SAE)
時間枠：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
時間枠：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)
時間枠：Baseline and Week 52
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Baseline and Week 52
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Number of Participants with Clinical laboratory abnormalities
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in WPAI:GH Presenteeism Score
時間枠：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
時間枠：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
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Systolic Blood Pressure (SBP)
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Diastolic Blood Pressure (DBP)
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change From Baseline in Total Cholesterol
時間枠：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)
時間枠：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)
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Non-HDL Cholesterol
時間枠：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
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from baseline in Triglycerides
時間枠：Baseline and Week 52
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Baseline and Week 52
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Change from Baseline in HbA1c (%) (T2D participants only)
時間枠：Baseline and Week 52
|
Baseline and Week 52
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- C6491023
- VESPER-OA 2 (その他の識別子：Alias Study Number)
- 2026-527180-15-00 (レジストリ識別子：CTIS (EU))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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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