A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-1)
Date de révision : 27/04/2026
18 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 26/04/2026
Critères :
Critères d'inclusion :
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Documented history of previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with PSG, HSAT (REI ≥ 15 by HSAT), or other method that meets local guidelines before screening.
- AHI ≥ 15 on PSG at day 1 before randomization.
- BMI ≥ 27 kg/m2 at screening.
- History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
- On PAP therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the study
Critères d'exclusion :
- Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery
- Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
- Have Type 1 or Type 2 Diabetes Mellitus, or any other type of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness.
- History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ that have been treated with curative intent).
- History of chronic pancreatitis.
- History of acute pancreatitis within 180 days before screening.
- 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 OSA other than PAP therapy (eg, 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
- 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 PSG testing during the course of the study
- Are unwilling or unsafe in the opinion of investigator to stop PAP therapy for 7 days before PSG testing during the course of the study
- Obesity induced by other endocrine disorders or monogenetic or syndromic forms of obesity.
- Self-reported change in body weight > 5 kg within 90 days before screening.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Centre Hospitalier Universitaire Grenoble Alpes
38043 Grenoble Cedex 9 France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".