Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy (MARITIME-OSA-2)
Key facts
- Where
- Budapest I, Debrecen, Gödöllő, Szeged és Törökbálint, MagyarországSee the 5 sites
- Phase
- 3. fázis
Where in Magyarország
- Somnius Kft.Budapest I, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Erzsebet Gondozohaz Kft.Gödöllő, MagyarországTaking people
- Somnius Kft.Szeged, MagyarországTaking people
- Református Pulmonológiai CentrumTörökbálint, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen Inc.
- Trial code
- EU 2025-522699-94-00
- Record updated
- 2026. november 2.
- 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 not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)
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; "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.".
Exclusion: Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA; History of acute pancreatitis within 180 days before screening; 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; Obesity induced by other endocrine disorders or monogenetic or syndromic forms of 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 in the opinion of the 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); All heart failure, including New York Heart Association Class IV; History of chronic pancreatitis; 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; 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; Active device treatment of OSA, or other treatments, that in the opinion of the investigator, may interfere with study outcomes.