NCT07369011招募中3 期
A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 115
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.
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
- Double (Participant, 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
- •Confirmed history of moderate-to-severe OSA
- •Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening
- •Have a BMI ≥27 kg/m2 at screening
- •Have a stable body weight (<5% body weight change) for 90 days prior to screening
- •Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
- •For YSA1 Participants:
- •Are unable or unwilling to use PAP therapy
- •For YSA2 Participants:
- •Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study
排除标准
- •Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
- •Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- •Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening
- •Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- •Have had within 90 days prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •coronary artery revascularization
- •unstable angina, or
- •hospitalization due to congestive heart failure
- •Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
- •Have taken medications or alternative remedies intended for weight loss within 90 days of screening
研究组 & 干预措施
Placebo (YSA1)
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
Placebo (YSA2)
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
Eloralintide (YSA1)
Experimental
Participants will receive eloralintide subcutaneously (SC)
干预措施: Eloralintide (Drug)
Eloralintide (YSA2)
Experimental
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 64
Change from Baseline in Apnea-Hypopnea Index (AHI)
时间窗: Baseline, Week 64
次要结局
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 64)
- Percent Change from Baseline in Triglycerides(Baseline, Week 64)
- Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)(Baseline, Week 64)
- Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score(Baseline, Week 64)
- Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10(Baseline, Week 64)
- Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)(Baseline, Week 64)
- Number of Participants who Achieve ≥50% decrease in AHI(Baseline, Week 64)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 64)
- Change from Baseline in Fasting Glucose(Baseline, Week 64)
- Change from Baseline in ESS Score(Baseline, Week 64)
- Change from Baseline in Short Form-36 (SF-36 v2) Scores(Baseline, Week 64)
- Change from Baseline in EQ-5D-5L Scores(Baseline, Week 64)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 64)
- Change from Baseline in Waist Circumference(Baseline, Week 64)
- Change in Medication Use(Baseline, Week 64)
- Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA)(Baseline, Week 64)
- Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)(Baseline through Week 64)
- PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)(Baseline through Week 64)
研究者
研究点 (115)
Loading locations...
相似试验
招募中
3 期
A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly IncretinObesityOverweightNCT07392190Eli Lilly and Company900
招募中
3 期
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 DiabetesOverweightObesityOverweightObesityNCT07282600Eli Lilly and Company1,035
进行中（未招募）
1 期
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal FunctionKidney Failure, ChronicKidney DiseaseRenal InsufficiencyRenal Insufficiency ChronicRenal ImpairmentEnd Stage Kidney DiseaseNCT07426380Eli Lilly and Company28
招募中
1 期
PBGENE-DMD Phase 1/2a Safety and Preliminary Efficacy Study in Duchenne Muscular Dystrophy (FUNCTION-DMD)Duchenne Muscular Dystrophy With Mutations Amenable to PBGENE-DMDNCT07429240Precision BioSciences, Inc.18
招募中
3 期
A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 DiabetesObesityOverweightObesityNCT07321886Eli Lilly and Company1,980