MARITIME-OSA-2

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)

20250002

Study Population

Obstructive sleep apnea (OSA) is a sleep disorder that affects your breathing while you sleep due to partial or complete blockage of the upper airways. Being overweight or having obesity is a condition involving having too much body fat.  Obstructive sleep apnea and overweight/obesity are connected, meaning each condition can worsen the other.

The goal of this study is to learn more about maridebart cafraglutide (MariTide) in people with moderate to severe obstructive sleep apnea (OSA) who are not on positive airway pressure (PAP-common treatment using a machine to deliver pressurised air which keeps the airway open during sleep) therapy and living with overweight, or obesity.

Maridebart cafraglutide (MariTide) is a drug that acts on 2 different proteins in the body that are linked to how your body uses energy.  It may help people to eat less, feel full and use the energy from food more efficiently.

Approximately 250 participants are planned to be randomized into this study, globally. Approximately 9 patients will be enrolled at our Monash Health Clayton site.

Eligible participants must be:

• Age ≥ 18 years and have a BMI ≥ 27 kg/m2
• have a diagnosis of Moderate-to-severe OSA confirmed by diagnostic evaluations (PSG, HSAT)
• had at least 1 unsuccessful attempt at weight loss by diet and exercise
• unwilling or unable to use PAP therapy

Participants that have other significant sleep disorders or conditions that influence the sleep/wake cycle, Type 1 or Type 2 Diabetes Mellitus and women who are pregnant or lactating will not be eligible to participate in the study.

Study Visits

• A total of 28 visits over approximately 2 years
• This study will consist of a screening period (5 weeks), a treatment period (88 weeks), and a 12-week safety follow up period

Study Requirements

• MariTide or placebo will be given as an injection under the skin every 4 weeks
• ECG, Blood tests
• Individualised lifestyle counselling
• Questionnaires
• 5 overnight sleep studies (PSG)

Clinical Trials Registry:

https://clinicaltrials.gov/study/NCT07226765