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

Purpose

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.

Conditions

  • Sleep Apnea, Obstructive
  • Obesity
  • Overweight

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eloralintide (YSA1) 		Participants will receive eloralintide subcutaneously (SC)
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo (YSA1) 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC
Experimental
Eloralintide (YSA2) 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo (YSA2) 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Cullman Clinical Trials
Cullman, Alabama 35055
Contact:
256-708-2826

Ark Clinical Research
Long Beach, California 90815
Contact:
562-997-1000

Collaborative Neuroscience Research, LLC
Los Alamitos, California 90720
Contact:
714-799-7799

Artemis Institute for Clinical Research
Riverside, California 92503
Contact:
951-374-1190

Care Access - Aurora
Aurora, Colorado 80012
Contact:
720-368-4865

Flourish Research - Miami, LLC
Miami, Florida 33135
Contact:
305-631-6704

PharmaDev Clinical Research Institute, LLC
Miami, Florida 33176
Contact:
305-420-5636

Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida 32504
Contact:
850-438-1136

Teak Research Consults
Lawrenceville, Georgia 30043

EBGS Clinical Research Center
Snellville, Georgia 30078
Contact:
770-729-4517

Care Access - Shreveport 2
Shreveport, Louisiana 71105
Contact:
318-209-3290

Flourish Research - Bowie
Bowie, Maryland 20715
Contact:
410-824-1342

Revive Research Institute, Inc.
Southfield, Michigan 48075
Contact:
248-829-3103

Headlands Research-Twin Cities
Maplewood, Minnesota 55109

Clayton Sleep Institute - St. Louis - Tesson Ferry Road
St Louis, Missouri 63123
Contact:
314-645-6005

Palm Research Center Tenaya
Las Vegas, Nevada 89128
Contact:
702-736-5161

The Sleep Spot - Maimonides
Albuquerque, New Mexico 87107
Contact:
505-998-7200

Rochester Clinical Research - Buffalo
Buffalo, New York 14127

CTI Clinical Research Center
Cincinnati, Ohio 45212
Contact:
513-721-3868

Bogan Sleep Consultants
Columbia, South Carolina 29201
Contact:
803-251-3093

FutureSearch Trials of Neurology
Austin, Texas 78731
Contact:
512-380-9925

Sleep Therapy Research Center
San Antonio, Texas 78229

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com