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Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1)
EU CTIS ID: 2025-522703-14-00
What this study is testing
To demonstrate that maridebart cafraglutide is superior to placebo for improvement in Apnea-Hypopnea Index (AHI)
- 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 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.
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.
- On PAP therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the study
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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 Japan; Australia; Brazil; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.