Sleep Apnea, ObstructivePhase 3ENLIGHTEN-3NCT07369011
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
A Phase 3 study testing Eloralintide in people with Sleep Apnea, Obstructive and Obesity, run by Eli Lilly and Company at 115 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Obesity, Overweight
- What is being tested?
- Eloralintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 115 sitesin 11 countries
- Study dates
- 10 Feb 2026to Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 and contacts
115 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
115 sites in 11 countries
United States23 sites, 23 recruiting
- Recruiting
The Sleep Spot - Maimonides
Albuquerque, New Mexico, 87107
505-998-7200
Kisria Rechul
- Recruiting
Care Access - Aurora
Aurora, Colorado, 80012
720-368-4865
Mauricio Waintrub
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
512-380-9925
Gregory Tempest
- Recruiting
Flourish Research - Bowie
Bowie, Maryland, 20715
410-824-1342
BARBARA HUTCHINSON
- Recruiting
Rochester Clinical Research - Buffalo
Buffalo, New York, 14127
Rajiv Jain
- Recruiting
CTI Clinical Research Center
Cincinnati, Ohio, 45212
513-721-3868
James Maynard
- Recruiting
Bogan Sleep Consultants
Columbia, South Carolina, 29201
803-251-3093
Laura Herpel
- Recruiting
Cullman Clinical Trials
Cullman, Alabama, 35055
256-708-2826
Randall Quinn
- Recruiting
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
702-736-5161
Samer Nakhle
- Recruiting
Teak Research Consults
Lawrenceville, Georgia, 30043
Kamar Alabi
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
562-997-1000
Apinya Vutikullird
- Recruiting
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
714-799-7799
Steven Reynolds
- Recruiting
Headlands Research-Twin Cities
Maplewood, Minnesota, 55109
Charlene McEvoy
- Recruiting
Flourish Research - Miami, LLC
Miami, Florida, 33135
305-631-6704
Mark Rosenthal
- Recruiting
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176
305-420-5636
Edward Mezerhane
- Recruiting
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504
850-438-1136
David Bear
- Recruiting
Artemis Institute for Clinical Research
Riverside, California, 92503
951-374-1190
Jack Vu
- Recruiting
Sleep Therapy Research Center
San Antonio, Texas, 78229
Nagwa Lamaie
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
210-545-4900
Michelle Welch
- Recruiting
Care Access - Shreveport 2
Shreveport, Louisiana, 71105
318-209-3290
David Green
- Recruiting
EBGS Clinical Research Center
Snellville, Georgia, 30078
770-729-4517
Aliu Sanni
- Recruiting
Revive Research Institute, Inc.
Southfield, Michigan, 48075
248-829-3103
Syed Raza
- Recruiting
Clayton Sleep Institute - St. Louis - Tesson Ferry Road
St Louis, Missouri, 63123
314-645-6005
Joseph Ojile
China22 sites, 22 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, 100029
Xiaolei Zhang
- Not yet recruiting
The First Hospital of Jilin University
Changchun, 130021
15843081103
Guixia Wang
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, 130041
Hanqing Cai
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, 410013
Ping Jin
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Yan Yang
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Tao Chen
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510360
Nuofu Zhang
- Not yet recruiting
The Second People's Hospital of Hefei
Hefei, 230011
86-13956099720
Jun Ye
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, 650034
18908710522
Yikun Zhou
- Not yet recruiting
Gansu Provincial Hospital
Lanzhou, 730000
Peilin Hui
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471003
13653880139
Hongwei Jiang
- Not yet recruiting
Jiangxi Provincial People's Hospital
Nanchang, 330038
13767035719
Zongyou Cheng
- Not yet recruiting
Nanjing First Hospital
Nanjing, 210006
Qian Li
- Not yet recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, 053007
xiaoyu Tan
- Not yet recruiting
Ningbo First Hospital
Ningbo, 315010
13757426626
Li Li
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, 200030
Shankai Yin
- Not yet recruiting
Shanghai East Hospital
Shanghai, 200120
You Yin
- Not yet recruiting
ShenZhen People's Hospital
Shenzhen, 518020
+8613510099301
Hanrong Cheng
- Not yet recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, 518110
Lingling Xu
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
Rui Chen
- Not yet recruiting
Wuxi People's Hospital
Wuxi, 214023
86-13812050092
Xiaowei ZHU
- Not yet recruiting
Xianyang Hospital of Yan'an University
Xianyang, 712000
Wei Zhang
India12 sites, 12 recruiting
- Not yet recruiting
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
Bengaluru, 560029
9113030135
Akshata S
- Not yet recruiting
St. Johns Medical College Hospital
Bengaluru, 560034
+91 9483702412
UMA MAHESWARI KRISHNASWAMY
- Recruiting
Utkal Institute of Medical Sciences and Hospital
Bhubaneswar, 751021
Satyajeet Sahoo
- Recruiting
Endolife Speciality Hospitals
Guntur, 522001
9849945577
GADDIPATI BABU
- Recruiting
KRIMS Hospital
Nagpur, 440010
Ashok Arbat
- Recruiting
All India Institute of Medical Sciences
New Delhi, 110029
Saurabh Mittal
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi, 110060
+919811051841
Sanjay Manchanda
- Recruiting
Deenanath Mangeshkar Hospital & Research Centre
Pune, 411004
Balasaheb Pawar
- Recruiting
All India Institute of Medical Sciences
Raipur, 492099
Dibakar Sahu
- Recruiting
All India Institute of Medical Sciences - Rishikesh
Rishikesh, 249203
+91-8890293424
Lokesh Saini
- Recruiting
Bhakti Vedanta Hospital and Research Institute
Thane, 401107
079 6900 2222
Ajay Godse
- Not yet recruiting
Rhythm Heart Institute - A Unit of SLPL
Vadodara, 390022
9925207953
Tejas Kakkad
Brazil10 sites
- Suspended
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
- Suspended
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
- Suspended
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, 90430-001
- Suspended
CEMER - Centro Médico do Recife
Recife, 51110-160
- Suspended
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
- Suspended
Prognosis Pesquisa Clínica
Santo André, 09040-010
- Suspended
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, 01228-000
- Suspended
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030
- Suspended
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
- Suspended
Incor - Instituto do Coracao
São Paulo, 05403-900
Japan10 sites, 10 recruiting
- Recruiting
Juntendo University Hospital
Bunkyō City, 113-8431
81120023812
Takatoshi Kasai
- Recruiting
Fukuoka University Hospital
Fukuoka, 814-0180
81120023812
Masaki Fujita
- Recruiting
Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima
Kitahiroshima, 061-1121
81120023812
Jun Miura
- Recruiting
Kirigaokatsuda Hospital
Kitakyushu, 802-0052
81120023812
Tetsuya Kawano
- Recruiting
Toranomon Hospital
Minatoku, 105-8470
81120023812
Satoshi Kasagi
- Recruiting
Osaka Kaisei Hospital
Osaka, 532-0003
81120023812
Saeko Osawa
- Recruiting
KKR Sapporo Medical Center
Sapporo, 062-0931
81120023812
Hiroshi Saito
- Recruiting
Yoyogi Sleep Disorder Center
Shibuya-ku, 151-0053
81120023812
Hideaki Nakayama
- Recruiting
Nakamura Clinic
Urasoe, 901-2132
81120023812
Kei Nakamura
- Recruiting
RESM Respiratory and Sleep Medical Care Clinic
Yokohama, 222-0033
81120023812
Ryutaro Shirahama
Spain9 sites, 9 recruiting
- Recruiting
Hospital Universitario de Guadalajara
Guadalajara, 19002
0034949209200
Olga Mediano
- Recruiting
Hospital Universitari de Santa Maria
Lleida, 25198
+34 (973) 70 53 72
Ferran Barbé Illa
- Recruiting
Hospital San Pedro
Logroño, 26006
677151261
Alejandra Roncero Lázaro
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Irene Cano Pumarega
- Recruiting
Instituto de Investigaciones del Sueño
Madrid, 28036
913454129
Diego Garcia Borreguero
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
+34917277011
Francisco Fran
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
951032734
Francisco Tinahones Madueno
- Recruiting
Hospital Quiron Infanta Luisa
Seville, 41010
670502836
MARGARITA RIVAS FERNANDEZ
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Candelaria Caballero Eraso
Australia8 sites, 8 recruiting
- Recruiting
Nightingale Research
Adelaide, 5000
Andrew Hamilton
- Recruiting
Flinders University
Bedford Park, 5042
61 8 74219780
Danny Eckert
- Recruiting
Box Hill Hospital
Box Hill, 3128
Ming Li Yee
- Recruiting
Core Research Group
Brisbane, 4064
61738765688
David Colquhoun
- Recruiting
Austin Health - Repatriation Hospital
Heidelberg West, 3081
0394962160
Elif Ekinci
- Recruiting
CDH Research Institute Pty Ltd
Maroochydore, 4558
07 5408 0900
Hansjoerg Seltenreich
- Recruiting
Gold Coast University Hospital
Southport, 4215
0432143849
George Tay
- Recruiting
TrialsWest - Spearwood
Spearwood, 6163
61893121931
Peter Bremner
Germany8 sites, 8 recruiting
- Recruiting
CIMS Studienzentrum Bamberg
Bamberg, 96049
0049951 51099580
Johannes Haas
- Recruiting
Advanced Sleep Research
Berlin, 10117
493028886770
Katharina Lederer
- Recruiting
InnoDiab Forschung Gmbh
Essen, 45136
49 201 89942100
Thomas Schürholz
- Recruiting
Siteworks GmbH - Hannover
Hanover, 30449
Adriana Kandziora
- Recruiting
Siteworks GmbH - Zentrum für klinische Studien Karlsruhe
Karlsruhe, 76137
004951151524740
Niels-Christian Hoellger
- Recruiting
Universitätsklinikum Marburg
Marburg, 35033
004964215862777
Christian Viniol
- Recruiting
RED-Institut GmbH
Oldenburg, 23758
0049436150630128
Thomas Schaum
- Recruiting
Somni bene
Schwerin, 19053
0049 385207980
Heike Benes
Canada6 sites, 6 recruiting
- Recruiting
MyCliniResearch, Inc.
Calgary, T2Z 3R6
5873320600
Wilfred Alonso
- Recruiting
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9
418-380-1112
Dominique Deschênes
- Recruiting
Alpha Recherche Clinique
Québec, G2J 0C4
Nancy Labrecque
- Recruiting
C.I.C. Saint-Laurent
Saint-Laurent, H4R 3C8
8193731128
Emilie Millaire
- Recruiting
Maple Leaf Research
Toronto, M5G 1K2
4164657936
Graham Smith
- Recruiting
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1
Pierre-Alexandre Menard
South Korea4 sites, 4 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si, 15355
Seung Hoon LEE
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
HYUNG-JU CHO
- Recruiting
Asan Medical Center
Seoul, 05505
Yoo-Sam Chung
- Recruiting
Korea University Guro Hospital
Seoul, 08308
IL-HO PARK
Taiwan3 sites, 3 recruiting
- Recruiting
China Medical University Hospital
Taichung, 40447
+886975681003
Liang-Wen Hang
- Recruiting
National Cheng-Kung Uni. Hosp.
Tainan, 704
886 62353535 ext 3985
Yi-Ching Yang
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
033281200 ext.3966
Hsueh-Yu Li
About this study
Official title: 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
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
- Being tested
- Eloralintide, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EloralintideDrug
Also called LY3841136
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide (YSA1) | Experimental | Participants will receive eloralintide subcutaneously (SC) Receives: Drug: Eloralintide |
| Placebo (YSA1) | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
| Eloralintide (YSA2) | Experimental | Participants will receive eloralintide SC Receives: Drug: Eloralintide |
| Placebo (YSA2) | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 64
Change from Baseline in Apnea-Hypopnea Index (AHI)
Measured: Baseline, Week 64
Secondary outcomes (18)
Change from Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 64
Percent Change from Baseline in Triglycerides
Measured: Baseline, Week 64
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Measured: Baseline, Week 64
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score
Measured: Baseline, Week 64
Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10
Measured: Baseline, Week 64
Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Measured: Baseline, Week 64
Number of Participants who Achieve ≥50% decrease in AHI
Measured: Baseline, Week 64
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 64
Change from Baseline in Fasting Glucose
Measured: Baseline, Week 64
Change from Baseline in ESS Score
Measured: Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Scores
Measured: Baseline, Week 64
Change from Baseline in EQ-5D-5L Scores
Measured: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Measured: Baseline, Week 64
Change from Baseline in Waist Circumference
Measured: Baseline, Week 64
Change in Medication Use
Measured: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA)
Measured: Baseline, Week 64
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
Measured: Baseline through Week 64
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Measured: Baseline through Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start10 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369011
- Sponsor's protocol ID
- 27764
- Other IDs
- J3R-MC-YDAO, J3R-MC-YSA1, J3R-MC-YSA2, 2025-523769-11-00, 2025
- Acronym
- ENLIGHTEN-3
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07369011
- Acronym / sponsor ID
- ENLIGHTEN-3 / 27764
- Conditions
- Sleep Apnea, Obstructive, Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eloralintide (YSA1) | Experimental | Drug: EloralintideParticipants will receive eloralintide subcutaneously (SC) |
| Placebo (YSA1) | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
| Eloralintide (YSA2) | Experimental | Drug: EloralintideParticipants will receive eloralintide SC |
| Placebo (YSA2) | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EloralintideAlso: LY3841136Administered SC | Drug | Eloralintide (YSA1), Eloralintide (YSA2) |
| PlaceboAdministered SC | Drug | Placebo (YSA1), Placebo (YSA2) |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 64
Change from Baseline in Apnea-Hypopnea Index (AHI)
Time frame: Baseline, Week 64
18 secondary outcomes
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 64
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 64
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 64
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score
Time frame: Baseline, Week 64
Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10
Time frame: Baseline, Week 64
Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Time frame: Baseline, Week 64
Number of Participants who Achieve ≥50% decrease in AHI
Time frame: Baseline, Week 64
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 64
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 64
Change from Baseline in ESS Score
Time frame: Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Scores
Time frame: Baseline, Week 64
Change from Baseline in EQ-5D-5L Scores
Time frame: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 64
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 64
Change in Medication Use
Time frame: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA)
Time frame: Baseline, Week 64
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
Time frame: Baseline through Week 64
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Time frame: Baseline through Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ENLIGHTEN-3)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
115 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eloralintide in people with Sleep Apnea, Obstructive and Obesity, run by Eli Lilly and Company at 115 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, China, India, Brazil, Japan and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Body Weight (time frame: Baseline, Week 64). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.