A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ENLIGHTEN-3)

Lilly

Status and phase: Begins enrollment this month; Phase 3

Conditions: Overweight; Sleep Apnea, Obstructive; Obesity

Treatments: Drug: Placebo; Drug: Eloralintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07369011

27764

J3R-MC-YSA2 (Other Identifier)

J3R-MC-YDAO (Other Identifier)

2025-523769-11-00 (EU Trial (CTIS) Number)

J3R-MC-YSA1 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 4 patient groups, including a placebo group

Eloralintide (YSA1)

Experimental group

Description:

Participants will receive eloralintide subcutaneously (SC)

Treatment:

Drug: Eloralintide

Placebo (YSA1)

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo

Eloralintide (YSA2)

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Placebo (YSA2)

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo