Phase 3 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of moderate-to-severe obstructive sleep apnea (OSA)
• People whose sleep study (done as part of the screening process) shows an AHI score of 15 or higher — this is a measure of how often breathing is interrupted during sleep
• People with a BMI of 27 or above at the time of screening
• People whose body weight has been stable (less than 5% change) for the 90 days before screening
• People who have tried at least one diet in the past to lose weight without success

For one group of participants (YSA1):

• People who are unable or unwilling to use PAP therapy (a breathing machine used during sleep)

For another group of participants (YSA2):

• People who have been using PAP therapy consistently for at least three months before screening and plan to keep using it throughout the study

Who may not be able to join:

• People who have had, or are planning to have, surgery for obesity — though liposuction, cryolipolysis (fat-freezing), or tummy tuck procedures may be acceptable if they were done more than one year before screening (confirm with trial site)
• People who have had, or are planning to have, an endoscopic procedure or device-based treatment for obesity — unless any device was removed more than six months before screening
• People who have previously had surgery for sleep apnea, or major ear, nose, or throat surgery that may still be affecting their breathing at the time of screening, or who are planning such surgery
• People who have any type of diabetes, including type 1, type 2, or other forms
• People who have experienced any of the following within the 90 days before screening: a heart attack, a stroke, a procedure to open blocked heart arteries, unstable chest pain (angina), or a hospital stay due to heart failure
• People who have been diagnosed with the most severe category of heart failure (known as New York Heart Association Class IV)
• People who have taken any prescription, over-the-counter, or alternative medicines intended for weight loss within the 90 days before screening

Important: Always verify eligibility with the trial site directly before applying.