A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
2026年9月11日 更新者：Pfizer
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 RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 1)
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 use 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 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
介入
入学 (推定)
258
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
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
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
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)
- Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study.
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
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
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：プラセボ
参加者は、皮下注射により一致するプラセボを受け取ります。
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皮下注射による
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実験的：Treatment Arm
Participants will receive berobenatide by Subcutaneous Injection.
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By 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 Apnea-Hypopnea Index (AHI)
時間枠：baseline, Week 52
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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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Percent 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 High-Sensitivity C-Reactive Protein (hs-CRP)
時間枠：Baseline , week 52
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Baseline , week 52
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Percent change from baseline in AHI
時間枠：Baseline, week 52
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Baseline, week 52
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Percentage of participants with ≥ 50% AHI reduction
時間枠：baseline ,week 52
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baseline ,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 who achieve either AHI <5 events/hour or AHI 5-14 events/hour with Epworth Sleepiness Scale (ESS) score ≤10
時間枠：baseline, week 52
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baseline, week 52
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Change From Baseline in Systolic Blood Pressure (SBP)
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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Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a T-score.
Higher scores indicate greater sleep-related impairment..
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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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Change from baseline in the PROMIS Sleep Disturbance Short Form 8b T-score.
Higher scores indicate greater sleep disturbance.
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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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Percentage of participants with apnea-hypopnea events less then 15
時間枠：Baseline, week 52
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Baseline, 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 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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Baseline, week 52
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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 Body Mass Index (BMI)
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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Change From Baseline in Neck Circumference
時間枠：Baseline, wee 52
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Baseline, wee 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) 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 With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
時間枠：Baseline, wee 52
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Baseline, wee 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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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 Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism 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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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 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 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 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
ここでは、この調査に関係する人々や組織を見つけることができます。
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
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月19日
一次修了 (推定)
2028年6月19日
研究の完了 (推定)
2028年6月19日
試験登録日
最初に提出
2026年9月11日
QC基準を満たした最初の提出物
2026年9月11日
最初の投稿 (実際)
2026年9月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月16日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- C6491020
- VESPER-OSA 1 (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?
はい
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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米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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