This clinical trial aims to test the safety and effectiveness of a medicine called IHL-42X for people with obstructive sleep apnea (OSA). OSA is a condition where breathing stops and starts during sleep. This study is for those who can't use or never used a machine called positive airway pressure (PAP) that helps keep airways open during sleep. The trial is split into two phases:
- Phase II: This part lasts 4 weeks and will compare two doses of IHL-42X to a placebo (a harmless pill that doesn't contain medicine) to find the best dose.
- Phase III: This phase continues for 52 weeks, testing the best dose found in Phase II against its separate ingredients and a placebo.
About 120 patients will participate in Phase II and around 440 patients in Phase III. Participants need to be at least 18 years old and can't use cannabis, certain drugs, or have certain medical conditions. They must agree to use birth control if necessary and attend all study visits. The study will provide compensation for time and travel.
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