Current partner codePEPTIDESDE
NCT07369011·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

800

Locations

129

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Eloralintide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Jan 27, 2026

  2. Study start

    Feb 10, 2026

  3. Primary completion

    Mar 2028

  4. Study completion

    Apr 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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 locations

129 registered sites.

Argentina · Australia · Brazil · Canada · China · Germany · India · Japan · South Korea · Spain · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.

Cullman Clinical Trials

Cullman, Alabama, United States

Ark Clinical Research

Long Beach, California, United States

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Care Access - Aurora

Aurora, Colorado, United States

Flourish Research - Miami, LLC

Miami, Florida, United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida, United States

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida, United States

Teak Research Consults

Lawrenceville, Georgia, United States

EBGS Clinical Research Center

Snellville, Georgia, United States

Care Access - Shreveport 2

Shreveport, Louisiana, United States

Flourish Research - Bowie

Bowie, Maryland, United States

Revive Research Institute, Inc.

Southfield, Michigan, United States

Headlands Research-Twin Cities

Maplewood, Minnesota, United States

Clayton Sleep Institute - St. Louis - Tesson Ferry Road

St Louis, Missouri, United States

Palm Research Center Tenaya

Las Vegas, Nevada, United States

The Sleep Spot - Maimonides

Albuquerque, New Mexico, United States

Rochester Clinical Research - Buffalo

Buffalo, New York, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Bogan Sleep Consultants

Columbia, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Sleep Therapy Research Center

San Antonio, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Cicemo Srl

Buenos Aires, Argentina

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Eloralintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.