This protocol is indicated for adult patients with metabolic dysfunction-associated steatohepatitis confirmed by histology, presenting with stage F2 or F3 liver fibrosis — but without cirrhosis. This is a clinically significant window where intervention can demonstrably alter fibrosis trajectory.
The evidence-based regimen for this population centres on a selective thyroid hormone receptor-beta (THR-β) agonist administered orally. The complete dosing strategy and full structured regimen are available in the protocol — only a partial outline is provided here.
Resmetirom can be used as a therapeutic agent in patients with MASH with F2/F3 liver fibrosis as histological improvement of steatohepatitis and liver fibrosis has been proven.
In conclusion, resmetirom demonstrated histologic improvement in steatohepatitis and fibrosis in adult patients with NASH without cirrhosis and F2/F3 fibrosis in a large phase III study, with its safety profile being similar to that of the placebo group.
In a multicenter, randomized, double-blind, placebo-controlled study (MAESTRO-NASH) involving 1,759 patients with NASH with histologically diagnosed F2/F3 liver fibrosis, resmetirom, a selective THR-β agonist, showed significant improvement in steatohepatitis in 25.9% of the 80-mg group and 29.9% of the 100-mg group without worsening of liver fibrosis compared to placebo (9.7%) (P<0.001).
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