Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy (MARITIME-OSA-2)
EU CTIS ID: 2025-522699-94-00
What this study is testing
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- "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.
You likely can't join if
- Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA
- 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.
See the full eligibility criteria
- "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."
- Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA
- 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.
- Clinically significant gastric-emptying abnormality (including, but not limited to gastroparesis and gastric outlet obstruction
- History of chronic pancreatitis.
- 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.
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Poland
- Czechia
- Germany
- Hungary
- Spain
- Japan
- Australia
- Brazil
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poland; Czechia; Germany; Hungary; Spain; Japan and 3 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.