ISSN 1662-4009 (online)

ey0021.15-2 | New Treatments | ESPEYB21

15.2. A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis

SA Harrison , P Bedossa , CD Guy , JM Schattenberg , R Loomba , R Taub , D Labriola , SE Moussa , GW Neff , ME Rinella , QM Anstee , MF Abdelmalek , Z Younossi , SJ Baum , S Francque , MR Charlton , PN Newsome , N Lanthier , I Schiefke , A Mangia , JM Pericas , R Patil , AJ Sanyal , M Noureddin , MB Bansal , N Alkhouri , L Castera , M Rudraraju , V Ratziu , the MAESTRO-NASH Investigators.

In Brief This phase 3 trial including 966 adults with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with fibrosis were randomly assigned (1:1:1 ratio) to once-daily resmetirom 80 mg or 100 mg or placebo. Resmetirom, both 80 and 100 mg daily, were superior to placebo with respect to NASH resolution and improvement in liver fibrosis.NASH resolution occurred more frequently in patients on 80-mg (25.9%) and 100-mg resmetirom (29.9%) than on placebo (...