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A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

RecruitingPhase 3Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Confirmed history of moderate-to-severe OSA * Have an AHI โ‰ฅ 15 on polysomnography (PSG) as part of the study at screening * Have a BMI โ‰ฅ27 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
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What it tests

  • Eloralintide
  • Placebo
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Where

115 sites
Cullman Clinical Trials
Cullman, United States
Ark Clinical Research
Long Beach, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, United States
Artemis Institute for Clinical Research
Riverside, United States
Care Access - Aurora
Aurora, United States
Flourish Research - Miami, LLC
Miami, United States
PharmaDev Clinical Research Institute, LLC
Miami, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, United States

โ€ฆand 107 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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