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NCT Number: NCT07369011

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eloralintide

Drug

Administered SC

Other names: LY3841136

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 64

  2. Change from Baseline in Apnea-Hypopnea Index (AHI)

    Time frame: Baseline, Week 64

Secondary outcomes

  1. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 64

  2. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

  7. Number of Participants who Achieve ≥50% decrease in AHI

    Time frame: Baseline, Week 64

  8. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 64

  9. Change from Baseline in Fasting Glucose

    Time frame: Baseline, Week 64

  10. Change from Baseline in ESS Score

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

  13. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 64

  14. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 64

  15. Change in Medication Use

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline through Week 64

  18. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: ENLIGHTEN-3

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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