Last updated 5 days ago
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
250 patients around the world
Available in United States, Brazil
Amgen
2Research sites
250Patients around the world
This study is for people with
Sleep disorders
Sleep apnea
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.Body Mass Index (BMI) of 27 kg/m^2 or more at the time of screening.History of at least one unsuccessful attempt at weight loss through diet and exercise.Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study.
- Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.Those with significant craniofacial abnormalities that may affect breathing at screening.Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.
Sites
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Recruiting
Hospital das Clínicas da FMUSP - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Recruiting
StudyMARITIME-OSA-2
SponsorAmgen
Study typeInterventional
Conditions
Sleep apnea
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07226765
