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)

20230225

About the Study

We are conducting a global clinical trial to evaluate maridebart cafraglutide (MariTide) in adults with moderate to severe obstructive sleep apnea (OSA) and overweight or obesity.

• Global enrollment: ~250 participants
• Monash Health Clayton site: ~9 participants

OSA is a sleep disorder where breathing repeatedly stops or becomes shallow during sleep due to airway blockage. Excess weight can worsen OSA, and OSA can make weight management harder. MariTide is an investigational medication that acts on two proteins involved in energy regulation. It may help reduce appetite, increase satiety, and improve energy use.

Who Can Join?

You may qualify if you:

• Are 18 years or older
• Have a BMI ≥ 27 kg/m²
• Have moderate-to-severe OSA confirmed by diagnostic evaluation (PSG or other approved method)
• Have tried and failed at least once to lose weight through diet and exercise
• Are unwilling or unable to use PAP therapy

Exclusions:

• Other significant sleep disorders or conditions affecting sleep/wake cycles
• Type 1 or Type 2 diabetes
• Pregnancy or breastfeeding

Study Details

• Duration: ~2 years
• Visits: 28 total
• Phases:
• • Screening: 5 weeks
  • Treatment: 88 weeks
  • Safety follow-up: 12 weeks

What’s Involved?

• MariTide or placebo injection under the skin every 4 weeks
• ECG and blood tests
• Individualized lifestyle counseling
• Questionnaires
• Five overnight sleep studies (PSG)

Clinical Trials Registry:

tba