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New treatment option for Sleep Apnea, Obstructive
Official title A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
ClinicalTrials.gov ID: NCT07369011
What this study is testing
What is Eloralintide?
Eloralintide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sleep apnea, obstructive.
Also referred to as LY3841136.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Riverside, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Pensacola, Florida, United States
- Lawrenceville, Georgia, United States
- Snellville, Georgia, United States
- Shreveport, Louisiana, United States
- Bowie, Maryland, United States
- Southfield, Michigan, United States
- Maplewood, Minnesota, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
- Cincinnati, Ohio, United States
- Columbia, South Carolina, United States
- Austin, Texas, United States
+ 88 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Long Beach, California, United States; Los Alamitos, California, United States; Riverside, California, United States; Aurora, Colorado, United States; Miami, Florida, United States and 102 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.