Eloralintide for Obstructive Sleep Apnea
(ENLIGHTEN-3 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive eloralintide or placebo subcutaneously for the duration of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive eloralintide SC
Participants will receive eloralintide subcutaneously (SC)
Participants will receive placebo SC
Participants will receive placebo SC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
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