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In a 12-month, randomized, double-blind, placebo-controlled clinical trial, obeticholic acid significantly improved the biochemical markers of disease activity compared with placebo. The primary endpoint was achieved in a large proportion of patients in both the obeticholic acid 10 mg group and the obeticholic acid dose-adjustment group, whereas only a small number of patients in the placebo group achieved it.
FDA，2022.02
