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.
研究概览
研究类型
介入性
注册 (估计的)
258
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pfizer CT.gov Call Center
- 电话号码：1-800-718-1021
- 邮箱：ClinicalTrials.gov_Inquiries@pfizer.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
参与者将通过皮下注射接受匹配的安慰剂。
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皮下注射
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实验性的：Treatment Arm
Participants will receive berobenatide by Subcutaneous Injection.
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By Subcutaneous Injection
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change From Baseline in Apnea-Hypopnea Index (AHI)
大体时间：baseline, Week 52
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baseline, Week 52
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent Change From Baseline in Body Weight
大体时间：Baseline, Week 52
|
Baseline, Week 52
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Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
大体时间：Baseline , week 52
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Baseline , week 52
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Percent change from baseline in AHI
大体时间：Baseline, week 52
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Baseline, week 52
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Percentage of participants with ≥ 50% AHI reduction
大体时间：baseline ,week 52
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baseline ,week 52
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Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
大体时间：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
大体时间：baseline, week 52
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baseline, week 52
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Change From Baseline in Systolic Blood Pressure (SBP)
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline, week 52
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Baseline, week 52
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Percentage of participants with apnea-hypopnea events less then 15
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Epworth Sleepiness Scale Total Score
大体时间：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
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in IWQOL-Lite-CT Physical Composite Score
大体时间：Baseline, week 52
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Baseline, week 52
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Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in IWQoL-Lite-CT Total Score
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Body Weight
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Body Mass Index (BMI)
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Waist Circumference
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Neck Circumference
大体时间：Baseline, wee 52
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Baseline, wee 52
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Change From Baseline in Short Form 36-Item ((SF-36)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Week 52
|
Week 52
|
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Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
大体时间：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
大体时间：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
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in WPAI:GH Presenteeism Score
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in WPAI:GH Work Productivity Loss Score
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in WPAI:GH Activity Impairment Score
大体时间：Baseline, week 52
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Baseline, week 52
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Number of participants with Treatment-Emergent Adverse Event (TEAE)
大体时间：Week 52
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Week 52
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Number of participants with Serious Adverse Event (SAE)
大体时间：Week 52
|
Week 52
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Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
大体时间：Week 52
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Week 52
|
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Number of participants with Adverse Events of Special Interest (AESI)
大体时间：Week 52
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Week 52
|
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Number of participants with clinical laboratory abnormalities
大体时间：Week 52
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Week 52
|
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Change From Baseline in Diastolic Blood Pressure
大体时间：Baseline, week 52
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Baseline, week 52
|
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Change From Baseline in Total Cholesterol
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Non-HDL Cholesterol
大体时间：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
大体时间：Baseline, week 52
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Baseline, week 52
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Change From Baseline in Triglycerides
大体时间：Baseline, week 52
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Baseline, week 52
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月19日
初级完成 (估计的)
2028年6月19日
研究完成 (估计的)
2028年6月19日
研究注册日期
首次提交
2026年9月11日
首先提交符合 QC 标准的
2026年9月11日
首次发布 (实际的)
2026年9月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- C6491020
- VESPER-OSA 1 (其他标识符：Alias Study Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.