A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ENLIGHTEN-3)

2025-523769-11-00 Protocol J3R-MC-YDAO Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 30 Apr 2026 · Status Authorised, recruiting · 2 EU/EEA countries · 17 sites · Protocol J3R-MC-YDAO

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 800
Countries 2
Sites 17

Overweight

To demonstrate that eloralintide is superior to placebo for change in body weight and apnea-hypopnea index.

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
30 Apr 2026 → ongoing
Decision date (initial)
2026-04-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2025-523769-11-00
WHO UTN
U1111-1331-9837

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Pharmacogenetic, Pharmacodynamic

To demonstrate that eloralintide is superior to placebo for change in body weight and apnea-hypopnea index.

Conditions and MedDRA coding

Overweight

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Have a confirmed history of moderate-to-severe obstructive sleep apnea (OSA)
  2. Have a stable body weight (<5% body weight change) for 90 days prior to screening
  3. Have an Apnea-Hypopnea Index (AHI) ≥ 15 on polysomnography (PSG) as part of the study at screening
  4. For YSA1 participants: be unable or unwilling to use positive airway pressure (PAP) therapy
  5. 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 5

  1. Have had or are planning to have surgery, an endoscopic procedure, and/or devicebased therapy for weight loss (with exceptions)
  2. Have had or are planning to have surgery for sleep apnea or major ear, nose, or throat surgery that still may affect breathing at the time of screening
  3. Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
  4. Have had a serious heart condition within 90 days prior to screening
  5. Have taken medications or alternative remedies intended for weight loss within 90 days prior to screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percent Change from Baseline in Body Weight

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Eloralintide

PRD13082120 · Product

Active substance
LY3841136 Sodium
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
64 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Eloralintide

PRD13082122 · Product

Active substance
LY3841136 Sodium
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
64 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Eloralintide

PRD13082121 · Product

Active substance
LY3841136 Sodium
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
64 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Eloralintide

PRD13082123 · Product

Active substance
LY3841136 Sodium
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
64 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 10

OrganisationCity, countryDuties
Parexel International Corp.
ORG-100007310
 Auburndale, United States Laboratory analysis
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Data management
Trialbee AB
ORG-100051369
 Malmo, Sweden Other
IQVIA Limited
ORG-100008655
 Reading, United Kingdom On site monitoring
Iqvia Inc.
ORG-100010622
 Durham, United States Laboratory analysis
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Data management
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States Data management
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis

Locations

2 EU/EEA countries · 17 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Authorised, recruitment pending 84 8
Spain Ongoing, recruiting 85 9
Rest of world
Korea, Republic of, Australia, United States, Canada, Japan, China, Brazil, Taiwan, Argentina
 — 631 —

Investigational sites

Germany

8 sites · Authorised, recruitment pending
Siteworks GmbH
N/A, Ettlinger Strasse 5a, Suedstadt, Karlsruhe
Siteworks GmbH
N/A, Niemeyerstrasse 21, Linden-Mitte, Hanover
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Universitätsklinikum Marburg
Klinik für Pneumologie, Intensiv- und Schlafmedizin, Baldingerstrasse, Schlafmedizinisches Zentrum, Marburg
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH
N/A, Goethestrasse 1, Feldstadt, Schwerin
CIMS Studienzentrum Bamberg GmbH
N/A, Buger Strasse 82, Berg, Bamberg
Advanced Sleep Research GmbH
N/A, Luisenstrasse 55, Mitte, Berlin

Spain

9 sites · Ongoing, recruiting
Hospital San Pedro
Respiratory, Calle Piqueras 98, 26006, Logrono
Hospital Universitari De Santa Maria
Respiratory / Sleep Disorders, Av Alcalde Rovira Roure 44, 25198, Lleida
Hospital Universitario La Paz
Respiratory, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario De Guadalajara SESCAM
Sleep Unit, Calle De Los Donantes De Sangre S/n, 19002, Guadalajara
Instituto De Investigaciones Del Sueno S.L.
NA, Calle Del Padre Damian 44, 28036, Madrid
Hospital Universitario Virgen De La Victoria
Endocrinology and nutrition, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario Ramon Y Cajal
Respiratory, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
University Hospital Virgen Del Rocio S.L.
Respiratory, Avenida De Manuel Siurot S/n, 41013, Sevilla

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2026-04-30 2026-05-06

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 53 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Master Protocol 2025-523769-11-00_Redacted a
Protocol (for publication) D1_Sub protocol YSA2 2025-523769-11-00_Redacted 1.0
Protocol (for publication) D1_Sub-protocol YSA1 2025-523769-11-00_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_Copyright Statement 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K2_recruitment material_ list of appreciation items_clean 1
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Clinical Trial Phases 1
Recruitment arrangements (for publication) K2_Recruitment Material_Clinical Trial Phases_clean 1
Recruitment arrangements (for publication) K2_Recruitment Material_Doctor letter to patient_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Doctor Referral Letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Doctor to Patient Letter_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_Master_clean 1
Recruitment arrangements (for publication) K2_Recruitment material_HbA1c Brochure 1
Recruitment arrangements (for publication) K2_Recruitment Material_Hba1c handout_clean 1
Recruitment arrangements (for publication) K2_Recruitment Material_Letter Doctor Refferal_clean 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
Recruitment arrangements (for publication) K2_Recruitment Material_Poster Master_clean 1
Recruitment arrangements (for publication) K2_Recruitment material_site specific recruitment text_siteworks 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trialbee_Global Privacy Policy 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trialbee_Landing Page_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trialbee_Marketing Content 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trialbee_Secondary Assessment_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trialbee_Self Assessment 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trialbee_Supplementary Information 1
Recruitment arrangements (for publication) K2_Recruitment material_Understanding Randomization 1
Recruitment arrangements (for publication) K2_Recruitment Material_Understanding Randomization_clean 1
Recruitment arrangements (for publication) K2_Recruitment material_What are Clinical Trials 1
Recruitment arrangements (for publication) K2_Recruitment Material_What are Clinical Trials_clean 1
Recruitment arrangements (for publication) K2_Recruitment material_What Is A Placebo 1
Recruitment arrangements (for publication) K2_Recruitment Material_What is Placebo_clean 1
Recruitment arrangements (for publication) K3_Recruitment digital campaign_Trialbee_Digital Marketing Content 1
Recruitment arrangements (for publication) K3_Recruitment digital campaign_Trialbee_Global Privacy Policy 1
Recruitment arrangements (for publication) K3_Recruitment digital campaign_Trialbee_Landing page_Redaction 1
Recruitment arrangements (for publication) K3_Recruitment digital campaign_Trialbee_Overview Supplementary Information 1
Recruitment arrangements (for publication) K3_Recruitment digital campaign_Trialbee_Secondary Assessment_Redacted 1
Recruitment arrangements (for publication) K3_Recruitment digital campaign_Trialbee_Self Assessment_Redaction 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum ICF Pregnancy_clean 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pareja embarazada_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Study Participant Contact Card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Participant Contact Card 1
Subject information and informed consent form (for publication) L3_ZoomHealth_RegulatorySubmission_CoverLetter 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_YDAO_2025-523769-11-00_ES_Redacted 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_YDAO_2025-523769-11-00_Redacted 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_YSA1_2025-523769-11-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_YSA1_2025-523769-11-00_ES 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_YSA2_2025-523769-11-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_YSA2_2025-523769-11-00_ES 1.0

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-11-28 Germany Acceptable
2026-03-18
 2026-03-20

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