MARITIME-OSA-1 CPAP

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)

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Who can take part?

You may be able to take part if you have obstructive sleep apnoea (OSA), a condition where breathing can repeatedly stop or become shallow during sleep.

You may be eligible if you:

• Are 18 years of age or older
• Have moderate to severe OSA confirmed by a sleep study
• Have a BMI of 27 kg/m² or higher
• Have tried to lose weight through diet and exercise
• Are unable or unwilling to use positive airway pressure (PAP) therapy

You would not be able to take part if:

• You have another significant sleep disorder or condition affecting sleep
• You have diabetes
• You are pregnant or breastfeeding
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether MariTide, an investigational medication, may help improve sleep apnoea and weight-related outcomes.

Participants will be randomly assigned to receive either the study medication or a placebo.

• Study duration: Approximately 2 years
• Clinic visits: 28 visits during the study

The study includes:

• A screening period (5 weeks)
• A treatment period (88 weeks)
• A follow-up period (12 weeks)

What will I need to do?

If you take part, you will be asked to:

• Receive the study medication as an injection under the skin every 4 weeks
• Attend regular clinic visits and study appointments
• Take part in assessments, which may include:
• • Blood tests
  • A heart tracing (ECG)
  • Questionnaires about your health and sleep
  • Overnight sleep studies (up to five)
• Participate in lifestyle counselling

You will also have regular contact with the study team throughout the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – MariTide Study