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RecruitingPhase 3

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

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well eloralintide works and how safe it is for people with moderate-to-severe obstructive sleep apnea and overweight or obesity. Sleep apnea causes breathing to stop and start during sleep. The study lasts about 76 weeks and has separate groups based on use of positive airway pressure (PAP), a treatment that uses air pressure to keep airways open.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed history of moderate-to-severe obstructive sleep apnea.
  • Have at least 15 pauses or drops in breathing per hour on a sleep test done during study screening.
  • Have a body mass index (BMI) of at least 27 at screening. BMI is a measure based on height and weight.
  • Have had less than a 5% change in body weight during the 90 days before screening.
  • Report at least one past attempt to lose weight by changing your diet that did not work.
  • For the YSA1 group: be unable or unwilling to use PAP treatment.
  • For the YSA2 group: have used PAP treatment for at least 3 months in a row before screening and plan to keep using it during the study.

Who can't join

  • Have had or plan to have weight-loss surgery. Liposuction, fat-freezing treatments, or a tummy tuck are allowed if done more than 1 year before screening.
  • Have had or plan to have a weight-loss procedure using a scope or device. Past device treatment is allowed if the device was removed more than 6 months before screening.
  • Have had or plan to have sleep apnea surgery or major ear, nose, or throat surgery that may still affect breathing at screening.
  • Have any type of diabetes.
  • Within 90 days before screening, have had a heart attack, stroke, procedure to restore blood flow to the heart, unstable chest pain, or a hospital stay for heart failure.
  • Have or have had Class IV heart failure, the most severe level of heart failure.
  • Have used medicines or alternative remedies meant for weight loss within 90 days before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (23)

AL

CA

CO

FL

GA

LA

MD

MI

MN

MO

NM

NV

NY

  • Rochester Clinical Research - Buffalo · Buffalo, NY 14127Rajiv Jain · Principal investigatorMore trials in Buffalo

OH

SC

TX