No improvement in the histology of non-alcoholic steatohepatitis (NASH) was observed in patients who underwent ezetimibe treatment (a lipid lowering drug able to promote cholesterol efflux from the liver) plus lifestyle and dietary modification, vs those with lifestyle and dietary modification alone.

• In a phase IV 52 weeks double blind parallel randomized controlled trial (LISTEN trial), researchers assessed the impact of ezetimibe plus lifestyle and dietary intervention (eze) vs lifestyle and dietary intervention alone (placebo) on progression and complications of NASH evaluated by liver histology.

• A total of 40 NASH patients were randomized and received a follow-up of 52 weeks, when they underwent a second liver biopsy; 30 patients completed the study.

• Main composite endpoint (EP) was based on the histological improvement in the severity of NASH.

• No improvement in the primary EP was achieved with eze treatment vs placebo, with odds ratio of 1.029 (0.18-6.38).

• Treatment emergent adverse events were not more prevalent in the treatment arm.