Recruiting
Phase 3

Eloralintide

Sponsor:

Eli Lilly and Company

Code:

NCT07369011

Conditions

Sleep Apnea, Obstructive

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eloralintide

Placebo

Study Details

Brief 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. 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

Study ID

NCT07369011

Start date

Feb 10, 2026

Status verified date

Sep, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Eloralintide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Care Access - Aurora

Recruiting

Aurora, Colorado, United States, 80012

Contacts

720-368-4865

Principal Investigator:

Mauricio Waintrub

Care Access - Shreveport 2

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

318-209-3290

Principal Investigator:

David Green

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.