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

Official Summary

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.

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 800 participants

Study Arms

• Eloralintide (YSA1) (EXPERIMENTAL)
  Participants will receive eloralintide subcutaneously (SC)
• Placebo (YSA1) (PLACEBO_COMPARATOR)
  Participants will receive placebo SC
• Eloralintide (YSA2) (EXPERIMENTAL)
  Participants will receive eloralintide SC
• Placebo (YSA2) (PLACEBO_COMPARATOR)
  Participants will receive placebo SC

Interventions

• DRUG: Eloralintide — Administered SC
• DRUG: Placebo — Administered SC

Primary Outcomes

• Percent Change from Baseline in Body Weight (Baseline, Week 64)
• Change from Baseline in Apnea-Hypopnea Index (AHI) (Baseline, Week 64)

Secondary Outcomes

• 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)

Eligibility Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Trial Locations

• Cullman Clinical Trials, Cullman, Alabama, United States
• Ark Clinical Research, Long Beach, California, United States
• Collaborative Neuroscience Research, LLC, Los Alamitos, California, United States
• Artemis Institute for Clinical Research, Riverside, California, United States
• Care Access - Aurora, Aurora, Colorado, United States
• Flourish Research - Miami, LLC, Miami, Florida, United States
• PharmaDev Clinical Research Institute, LLC, Miami, Florida, United States
• Emerald Coast Neurology - Airport Boulevard, Pensacola, Florida, United States
• Teak Research Consults, Lawrenceville, Georgia, United States
• EBGS Clinical Research Center, Snellville, Georgia, United States
• ...and 10 more locations

Contact Information

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or — CONTACT
  Phone: 1-317-615-4559
  Email: LillyTrials@Lilly.com
• Physicians interested in becoming principal investigators please contact — CONTACT
  Email: clinical_inquiry_hub@lilly.com

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) — STUDY_DIRECTOR
  Eli Lilly and Company

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