Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1)

Trial details

Who runs it

Amgen Inc.

Trial code

EU 2025-522703-14-00

Record updated

2026. október 5.

Original description

To demonstrate that maridebart cafraglutide is superior to placebo for improvement in Apnea-Hypopnea Index (AHI)Read full original descriptionShow less

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)

To demonstrate that maridebart cafraglutide is superior to placebo for improvement in Apnea-Hypopnea Index (AHI)

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.

Exclusion: Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA; 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; 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; Self-reported change in body weight > 5 kg within 90 days before screening; Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity; History of acute pancreatitis within 180 days before screening; 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; Obesity induced by other endocrine disorders or monogenetic or syndromic forms of obesity; All heart failure, including New York Heart Association Class IV; 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 in the opinion of investigator; 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; Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before PSG testing during the course of the study; Clinically significant gastric-emptying abnormality (including, but not limited to gastroparesis and gastric outlet obstruction); Significant craniofacial abnormalities that may affect breathing at screening; Diagnosis of Central Apnea or Mixed Sleep with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.

EU CTIS 2025-522703-14-00