Eloralintide for Obstructive Sleep Apnea

(ENLIGHTEN-3 Trial)

Not yet recruiting at 121 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe obstructive sleep apnea and obesity or overweight. Participants must have a BMI of at least 27, stable weight in the last 90 days, and either be using PAP therapy for over three months or be unable to use it. They should also have tried dieting without success.

Inclusion Criteria

I have been diagnosed with moderate-to-severe sleep apnea.
My sleep study shows I have moderate to severe sleep apnea.
My BMI is 27 or higher.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eloralintide or placebo subcutaneously for the duration of the study

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide

Trial Overview

The study tests Eloralintide's effectiveness and safety in treating sleep apnea combined with obesity. It includes two groups: one taking Eloralintide and another receiving a placebo. The trial lasts about 76 weeks, with participants grouped based on their PAP therapy usage.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Eloralintide (YSA2)Experimental Treatment1 Intervention
Group II: Eloralintide (YSA1)Experimental Treatment1 Intervention
Group III: Placebo (YSA1)Placebo Group1 Intervention
Group IV: Placebo (YSA2)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University