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

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT07369011
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Eloralintide (YSA1)
    Participants will receive eloralintide subcutaneously (SC)
  • Placebo Comparator: Placebo (YSA1)
    Participants will receive placebo SC
  • Experimental: Eloralintide (YSA2)
    Participants will receive eloralintide SC
  • Placebo Comparator: Placebo (YSA2)
    Participants will receive placebo SC

Primary Outcome Measure

Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 64 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
  • Physicians interested in becoming principal investigators please contact

Locations (23)

FacilityCityStateZIPSite coordinators
Cullman Clinical TrialsCullmanAlabama35055
256-708-2826
Randall Quinn (PRINCIPAL_INVESTIGATOR)
Ark Clinical ResearchLong BeachCalifornia90815
562-997-1000
Apinya Vutikullird (PRINCIPAL_INVESTIGATOR)
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720
714-799-7799
Steven Reynolds (PRINCIPAL_INVESTIGATOR)
Artemis Institute for Clinical ResearchRiversideCalifornia92503
951-374-1190
Jack Vu (PRINCIPAL_INVESTIGATOR)
Care Access - AuroraAuroraColorado80012
720-368-4865
Mauricio Waintrub (PRINCIPAL_INVESTIGATOR)
Flourish Research - Miami, LLCMiamiFlorida33135
305-631-6704
Mark Rosenthal (PRINCIPAL_INVESTIGATOR)
PharmaDev Clinical Research Institute, LLCMiamiFlorida33176
305-420-5636
Edward Mezerhane (PRINCIPAL_INVESTIGATOR)
Emerald Coast Neurology - Airport BoulevardPensacolaFlorida32504
850-438-1136
David Bear (PRINCIPAL_INVESTIGATOR)
Teak Research ConsultsLawrencevilleGeorgia30043
Kamar Alabi (PRINCIPAL_INVESTIGATOR)
EBGS Clinical Research CenterSnellvilleGeorgia30078
770-729-4517
Aliu Sanni (PRINCIPAL_INVESTIGATOR)
Care Access - Shreveport 2ShreveportLouisiana71105
318-209-3290
David Green (PRINCIPAL_INVESTIGATOR)
Flourish Research - BowieBowieMaryland20715
410-824-1342
BARBARA HUTCHINSON (PRINCIPAL_INVESTIGATOR)
Revive Research Institute, Inc.SouthfieldMichigan48075
248-829-3103
Syed Raza (PRINCIPAL_INVESTIGATOR)
Headlands Research-Twin CitiesMaplewoodMinnesota55109
Charlene McEvoy (PRINCIPAL_INVESTIGATOR)
Clayton Sleep Institute - St. Louis - Tesson Ferry RoadSt LouisMissouri63123
314-645-6005
Joseph Ojile (PRINCIPAL_INVESTIGATOR)
Palm Research Center TenayaLas VegasNevada89128
702-736-5161
Samer Nakhle (PRINCIPAL_INVESTIGATOR)
The Sleep Spot - MaimonidesAlbuquerqueNew Mexico87107
505-998-7200
Kisria Rechul (PRINCIPAL_INVESTIGATOR)
Rochester Clinical Research - BuffaloBuffaloNew York14127
Rajiv Jain (PRINCIPAL_INVESTIGATOR)
CTI Clinical Research CenterCincinnatiOhio45212
513-721-3868
James Maynard (PRINCIPAL_INVESTIGATOR)
Bogan Sleep ConsultantsColumbiaSouth Carolina29201
803-251-3093
Laura Herpel (PRINCIPAL_INVESTIGATOR)
FutureSearch Trials of NeurologyAustinTexas78731
512-380-9925
Gregory Tempest (PRINCIPAL_INVESTIGATOR)
Sleep Therapy Research CenterSan AntonioTexas78229
Nagwa Lamaie (PRINCIPAL_INVESTIGATOR)
Consano Clinical Research, LLCShavano ParkTexas78231
210-545-4900
Michelle Welch (PRINCIPAL_INVESTIGATOR)

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