Promising Phase 3 Data for Resmetirom Suggests It May Address ‘Monumental’ Unmet Need in NASH

In this interview with HCPLive, Stephen Harrison, MD, provides insight into the use of resmetirom for nonalcoholic steatohepatitis (NASH) with fibrosis based on data from the phase 3 MAESTRO-NASH trial ahead of the thyroid hormone receptor-β selective agonist’s March 14 PDUFA date.
An oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver, resmetirom’s safety and efficacy for adults with NASH has been demonstrated in phase 2 and 3 trials. MAESTRO-NASH, a phase 3, double-blind, randomized, placebo-controlled trial, is 1 of 18 studies in resmetirom’s clinical development program supporting the NDA for its use in adult patients with NASH and fibrosis.
Results showed NASH resolution with no worsening of fibrosis was achieved in 25.9% of the patients in the resmetirom 80 mg group and 29.9% of those in the resmetirom 100 mg group, compared to 9.7% of those in the placebo group (P ＜.001). Fibrosis improvement by at least 1 stage with no worsening of the NAFLD activity score was also superior in the resmetirom 80 mg (24.2%) and resmetirom 100 mg (25.9%) groups versus the placebo group (14.2%; P ＜.001).
Additionally, the change in LDL cholesterol levels from baseline to week 24 was −13.6% in the resmetirom 80 mg group and −16.3% in the resmetirom 100 mg group, as compared with 0.1% in the placebo group (P＜.001).
Full articles:
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#hepatology #fattyliver #NASH

[@akarshswrld]

Going to present my journal club presentation on this trial coming friday.

[@kirondeodhar3077]

Sir,I am 72,diagonised NAFLD disease three months back,thanks for every good information about new drug,earlier stage after Fibroscan,score was 16.2, later after one mothafter endoscopy diagnosed with ascites,now undertook diuretic drug,very much improvement,so want your advise if this stage can be cured order ,reversed or stopped further progress by the new drug. I have no BP,No diabetes,you advise is requested

[@mihirpal8561]

Is resmetirom for NAFLD or for NASH or for both? My dad has stage 1 NAFLD. Does he need to take resmetirom?

[@sergimarievich4683]

Дякую