RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
The goal of this randomised, double-blind phase II/III clinical trial is to determine the
safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant,
non-compliant, or naïve to positive airway pressure.
Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to
placebo. The optimal dose strength will be selected based on comparing the safety and
efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The
three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X
High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol
approximately 40 patients per treatment arm, for a total of approximately 120 patients.
The safety and efficacy results of the Phase II study will be used to select the dose
strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III.
Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will
be compared to the component active pharmaceutical ingredients at equivalent dose strengths
to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four
treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose
strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength
to that in the IHL-42X optimal dose strength) and placebo. The treatment groups will enrol
approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately
55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440
patients.