NCT07823608尚未招募3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 258
- 主要终点
- Change From Baseline in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Treatment Arm
Experimental
Participants will receive berobenatide by Subcutaneous Injection.
干预措施: Berobenatide (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo by Subcutaneous Injection.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Apnea-Hypopnea Index (AHI)
时间窗: baseline, Week 52
次要结局
- Percent Change From Baseline in Body Weight(Baseline, Week 52)
- Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline , week 52)
- Percent change from baseline in AHI(Baseline, week 52)
- Percentage of participants with ≥ 50% AHI reduction(baseline ,week 52)
- Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)(Baseline, week 52)
- Percentage of participants who achieve either AHI <5 events/hour or AHI 5-14 events/hour with Epworth Sleepiness Scale (ESS) score ≤10(baseline, week 52)
- Change From Baseline in Systolic Blood Pressure (SBP)(Baseline, week 52)
- Change From Baseline in IWQOL-Lite-CT Physical Composite Score(Baseline, week 52)
- Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score(Baseline, week 52)
- Change From Baseline in IWQoL-Lite-CT Total Score(Baseline, week 52)
- Change From Baseline in Body Weight(Baseline, week 52)
- Change From Baseline in Body Mass Index (BMI)(Baseline, week 52)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-score(baseline, week 52)
- Change From Baseline in PROMIS Sleep Disturbance 8b T-score(Baseline, week 52)
- Change from baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score(Baseline, week 52)
- Percentage of participants with apnea-hypopnea events less then 15(Baseline, week 52)
- Change From Baseline in Epworth Sleepiness Scale Total Score(Baseline, week 52)
- Change from baseline in IWQoL-Lite-CT physical function composite score(Baseline, week 52)
- Change From Baseline in Waist Circumference(Baseline, week 52)
- Change From Baseline in Neck Circumference(Baseline, wee 52)
- Change From Baseline in Short Form 36-Item ((SF-36)(Baseline, week 52)
- Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category(Week 52)
- Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category(Week 52)
- Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category(Baseline, wee 52)
- Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness(Week 52)
- Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue(Week 52)
- Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality(Week 52)
- Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring(Week 52)
- Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score(Baseline, week 52)
- Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score(Baseline, week 52)
- Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score(Baseline, week 52)
- Change From Baseline in WPAI:GH Presenteeism Score(Baseline, week 52)
- Change From Baseline in WPAI:GH Work Productivity Loss Score(Baseline, week 52)
- Change From Baseline in WPAI:GH Activity Impairment Score(Baseline, week 52)
- Number of participants with Treatment-Emergent Adverse Event (TEAE)(Week 52)
- Number of participants with Serious Adverse Event (SAE)(Week 52)
- Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study(Week 52)
- Number of participants with Adverse Events of Special Interest (AESI)(Week 52)
- Number of participants with clinical laboratory abnormalities(Week 52)
- Change From Baseline in Diastolic Blood Pressure(Baseline, week 52)
- Change From Baseline in Total Cholesterol(Baseline, week 52)
- Change From Baseline in High-density lipoprotein cholesterol (HDL-C)(Baseline, week 52)
- Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)(Baseline, week 52)
- Change From Baseline in Non-HDL Cholesterol(Baseline, week 52)
- Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol(Baseline, week 52)
- Change From Baseline in Triglycerides(Baseline, week 52)
研究者
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