A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2) (VESPER-OSA 2)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBSTRUCTIVE SLEEP APNEA AND OVERWEIGHT OR OBESITY NOT RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 2)
This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea [OSA]) and overweight or obesity who are not using a breathing machine (positive airway pressure [PAP] machine).
People may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been unable or unwilling using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training.
During the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.
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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Cullman、Alabama、アメリカ、35055
- 募集
- Cullman Clinical Trials
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Florida
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Bradenton、Florida、アメリカ、34209
- 募集
- DM Clinical Research-Bradenton
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Minnesota
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Maplewood、Minnesota、アメリカ、55109
- 募集
- Headlands Research - Twin Cities
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Texas
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Tomball、Texas、アメリカ、77375
- まだ募集していません
- DM Clinical Research-Tomball
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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 aged 18 years or older
- Body mass index (BMI) ≥27 kg/m² at screening
- Previously diagnosed with moderate to severe obstructive sleep apnea (OSA)
- Unable or unwilling to use positive airway pressure (PAP) therapy, and no use of PAP therapy for at least 4 weeks prior to screening
Exclusion Criteria:
- Self-reported body weight change of more than 5% within 90 days prior to screening
- Diagnosis of any type of diabetes (resolved gestational diabetes is permitted)
- History of acute or chronic pancreatitis
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) Sleep-disordered breathing conditions other than obstructive sleep apnea that could interfere with study assessments or interpretation of results (eg, central sleep apnea, mixed sleep apnea, Cheyne-Stokes respiration, obesity hypoventilation syndrome, or significant craniofacial abnormalities).
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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実験的：Berobenatide
Participants receive berobenatide by subcutaneous injection. |
Subcutaneous injection
他の名前：
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プラセボコンパレーター：Placebo
Participants receive volume-matched placebo |
Volume-matched subcutaneous placebo. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Apnea-Hypopnea Index
時間枠：Baseline, Week 52
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Apnea-Hypopnea Index is the number of apnea and hypopnea events per hour of sleep, assessed by polysomnography. |
Baseline, Week 52
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Body Weight
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Waist Circumference
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percent Change From Baseline in Body Weight
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
時間枠：Week 52
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Week 52
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
時間枠：Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
時間枠：Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
時間枠：Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
時間枠：Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
時間枠：Week 52
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Week 52
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Number of participants with Treatment-Emergent Adverse Event (TEAE)
時間枠：Week 52
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Week 52
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Number of participants with Serious Adverse Event (SAE)
時間枠：Week 52
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Week 52
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Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
時間枠：Week 52
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Week 52
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Number of participants with Adverse Events of Special Interest (AESI)
時間枠：Week 52
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Week 52
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Number of participants with clinical laboratory abnormalities
時間枠：Week 52
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Week 52
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Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
時間枠：Baseline, week 52
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Baseline, week 52
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Change From Baseline in High-Sensitivity C-Reactive Protein
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percent Change From Baseline in Apnea-Hypopnea Index
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percentage of Participants With at Least 50% Reduction in Apnea-Hypopnea Index
時間枠：Week 52
|
Week 52
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Change From Baseline in Sleep-Apnea-Specific Hypoxic Burden (SASHB)
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percentage of Participants With Obstructive Sleep Apnea Remission or Mild Non-Symptomatic Obstructive Sleep Apnea
時間枠：Week 52
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Week 52
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Change From Baseline in Systolic Blood Pressure
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in PROMIS Sleep Disturbance 8b T-Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percentage of Participants with AHI <5
時間枠：Week 52
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Week 52
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Percentage of Participants with AHI 5-14 with ESS (Epworth Sleepiness Scale) ≤10
時間枠：Week 52
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Week 52
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Percentage of participants with AHI less then 15
時間枠：Week 52
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Week 52
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Change From Baseline in Epworth Sleepiness Scale Total Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in IWQOL-Lite-CT Physical Composite Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in IWQOL-Lite-CT Psychosocial Composite Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in IWQOL-Lite-CT Total Score
時間枠：Baseline, Week 52
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Score ranges from 0 to 100; higher scores indicate better quality of life. |
Baseline, Week 52
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Change From Baseline in Body Mass Index
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Neck Circumference
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Short Form 36-Item (SF-36)
時間枠：Baseline, Week 52
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Baseline, Week 52
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
時間枠：Week 52
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Week 52
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Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in WPAI:GH Presenteeism Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in WPAI:GH Work Productivity Loss Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in WPAI:GH Activity Impairment Score
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Diastolic Blood Pressure
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Total Cholesterol
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Non-HDL Cholesterol
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
時間枠：Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in Triglycerides
時間枠：Baseline, Week 52
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Baseline, Week 52
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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
- C6491021
- VESPER-OSA 2 (その他の識別子：Alias Study Number)
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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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。