Trevi Therapeutics announced a positive outcome from the pre-planned sample size re-estimation (SSRE) for its ongoing Phase 2b CORAL trial. The analysis confirmed that no change is required to the current sample size of 160 patients for the trial.
The SSRE was conducted on the highest dose (108mg twice daily) after 50% of the initial targeted enrollment, or 80 patients, completed six weeks of treatment. The recommendation was to continue the trial as planned to maintain the pre-specified conditional power of 80% or greater.
This outcome de-risks the CORAL trial and reinforces the key powering assumptions of the study design. The trial has reached 75% of its targeted enrollment, with topline results from the full trial still expected in the first half of 2025.
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