Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for people with obesity or overweight who have moderate-to-severe obstructive sleep apnea. Participants will be assigned to a group based on their current use of sleep apnea treatment and will be involved for about 76 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with moderate-to-severe obstructive sleep apnea.
My apnea-hypopnea index (AHI) is 15 or higher.
My body mass index (BMI) is 27 or higher.
I have not changed my weight by more than 5% in the last 90 days.
I have tried to lose weight through diet but have not succeeded.
You may not be able to join if
I have had surgery for obesity within the last year.
I have had surgery for sleep apnea that affects my breathing.
I have type 1 or type 2 diabetes.
I have had a heart attack, stroke, or similar heart issue in the last 90 days.
I have a history of severe heart failure.
I have used weight loss medications or remedies in the last 90 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 pa…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 s…
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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