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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 (...

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ey0015.15-7 | New treatments | ESPEYB15

15.7 NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

SA Harrison , ME Rinella , MF Abdelmalek , JF Trotter , AH Paredes , HL Arnold , M Kugelmas , MR Bashir , MJ Jaros , L Ling , SJ Rossi , AM DePaoli , R Loomba

To read the full abstract: Lancet 2018;391:1174-1185Non-alcoholic fatty liver disease is highly prevalent in overweight and obese children and adults. It progresses to steatohepatitis (with raised liver transaminase levels) and fibrosis, and eventually to cirrhosis. Detecting this, excluding other causes of liver disease, and monitoring its progress t...

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ESPE Yearbook of Paediatric Endocrinology

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

15.7 NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

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