The P-III (MAESTRO-NASH) trial evaluates resmetirom (80 & 100mg, BID) vs PBO in patients (n=966) with biopsy-confirmed NASH & a fibrosis stage of F1B, F2, or F3to F4. The 1EPs were NASH resolution at wk52 with no worsening of fibrosis & a reduction in fibrosis
As per results, NASH resolution was achieved in 25.9% & 29.9% vs 9.7% of patients, reduction in fibrosis was seen in 24.2% & 25.9% vs 14.2% of patients & a 13.6% change in LDL cholesterol levels from baseline to wk24 was seen. The results were published in the New England Journal of Medicine
The study also met its 2EPs of reduction in liver enzymes (ALT, AST and GGT) from baseline & reductions in atherogenic lipids, lipoproteins, fibrosis biomarkers & imaging tests
Ref: Madrigal | Image: Madrigal
Related News:- Madrigal Reports Results of Resmetirom in P-III (MAESTRO-NAFLD-1) Study for the Treatment of Non-Alcoholic Steatohepatitis
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