ENLIGHTEN-3

RecruitingPhase 3

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

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

Lead sponsor

Eli Lilly and Company

Asset

Eloralintide

Subcutaneous · Amylin analog

Listed sites

131

Recruiting sites

Enrollment

800

estimated

Study population

Obesity / overweight, Sleep apnea

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•AHI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07369011

Org study ID27764

Secondary ID2025-523769-11-00

Secondary IDJ3R-MC-YDAOEli Lilly and Company

Secondary IDJ3R-MC-YSA1Eli Lilly and Company

Secondary IDJ3R-MC-YSA2Eli Lilly and Company

Timeline

Milestones

Study first posted2026-01-27actual

Study start2026-02-10actual

Last update posted2026-05-22actual

Primary completion2028-03estimated (month precision)

Study completion2028-04estimated (month precision)

Assets

Investigational agents

Eloralintide

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 64

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 64

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 64

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 64

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 64

percent change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 64

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 64

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 64

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score

Time frame:Baseline, Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in ESS Score

Time frame:Baseline, Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Short Form-36 (SF-36 v2) Scores

Time frame:Baseline, Week 64

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in EQ-5D-5L Scores

Time frame:Baseline, Week 64

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA)

Time frame:Baseline, Week 64

PGI, change

categorical status, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)

Time frame:Baseline through Week 64

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Change from Baseline in Apnea-Hypopnea Index (AHI)

Time frame:Baseline, Week 64

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10

Time frame:Baseline, Week 64

OSA responder

threshold achievement, improvement

componentsAHI, change, PGI, change

Secondary/protocol endpoint

Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)

Time frame:Baseline, Week 64

percent change from baseline, improvement

Secondary/protocol endpoint

Number of Participants who Achieve ≥50% decrease in AHI

Time frame:Baseline, Week 64

OSA responder

threshold achievement, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Medication Use

Time frame:Baseline, Week 64

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.