Interim results from a clinical trial of obeticholic acid for non-alcoholic steatohepatitis (NASH) show it significantly reduces fibrosis and will probably confer clinical benefit, international researchers report.

The trial, known as REGENERATE, is the first phase-3 trial of a drug for NASH to show a positive effect, the authors say.

More than 900 patients, across 20 countries, with NASH and F2 or F3 stage fibrosis — as defined by the NASH Clinical Research Network — were randomly allocated to three trial arms, comprising once-daily oral obeticholic acid (either 10mg or 25mg) or placebo.

At 18 months, liver biopsy showed that 23% of patients taking the higher dose of obeticholic acid had dropped by at least one fibrosis stage, and that their steatohepatitis had not worsened.