Obeticholic Acid
Participants in the trial receive OCA or placebo at 5 mg once daily until week 12, then may titrate to 10 mg once daily through week 26 according to tolerability. Preclinical cholestasis and human cell culture models suggest OCA can revers…
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Participants in the trial receive OCA or placebo at 5 mg once daily until week 12, then may titrate to 10 mg once daily through week 26 according to tolerability. Preclinical cholestasis and human cell culture models suggest OCA can reverse cellular senescence. Obeticholic acid is a first-in-class farnesoid X receptor agonist currently licensed as second-line therapy added to UDCA after UDCA failure. OPERA tests whether high-risk patients should receive OCA at the start of treatment rather than after a year of demonstrated UDCA non-response.