Last updated 7 days ago

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

250 patients around the world

Available in United States, Brazil

Amgen

1Research sites

250Patients around the world

This study is for people with

Obesity

Sleep disorders

Sleep apnea

To 99 Years

All Gender

: AHI ≥ 15 on polysomnography at day 1 before randomization.
BMI ≥ 27 kg/m^2 at screening.
History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.

: Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
Significant craniofacial abnormalities that may affect breathing at screening.
Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.
Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.

Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS

Recruiting

Rua Mostardeiro 5/310, Porto Alegre, Rio Grande do Sul

StudyMARITIME-OSA-1

SponsorAmgen

Study typeInterventional

Conditions

ObesitySleep apnea

Requirements

To 99 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07225686