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

What Was Tested

This registered phase 3 trial tested Eloralintide for sleep apnea (obstructive).

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.

It had four arms (groups): Eloralintide (YSA1) (experimental), Placebo (YSA1) (placebo comparator), Eloralintide (YSA2) (experimental) and Placebo (YSA2) (placebo comparator).

Participants will receive eloralintide subcutaneously (SC).

Participants will receive placebo SC.

Participants will receive eloralintide SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 800 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. Are unable or unwilling to use PAP therapy. Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The sleep apnea (obstructive) participants were allocated by chance, so the Eloralintide group and the comparison group should start out alike.

Groups ran in parallel: each of the sleep apnea (obstructive) participants stayed in one arm throughout.

Neither the sleep apnea (obstructive) participants nor the staff measuring them knew who was on Eloralintide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-02-10 with completion listed for 2028-03.

It ran at 115 sites in United States (23), China (22), India (12), Brazil (10), Japan (10) and Spain (9).

Its stated primary purpose is treatment.

What Was Measured

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).

It also tracked 18 secondary outcomes, for example Change from Baseline in Systolic Blood Pressure (SBP), Percent Change from Baseline in Triglycerides, Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP), Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score, Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 and Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Eloralintide in 800 people with sleep apnea (obstructive).

With 800 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Eloralintide compound page, Sleep apnea (obstructive) research.