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Stephen A. Harrison, Pierre Bédossa, Cynthia D. Guy, Jörn Markus Schattenberg, Rohit Seth Loomba, Rebecca A. Taub, Dominic Labriola, Sam E. Moussa, Guy W. Neff, Mary Eugenia Rinella and 19 more
BACKGROUND: Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. Resmetirom is an oral, liver-directed, thyroid hormone receptor beta-selective agonist in development for the treatment of NASH with liver fibrosis. METHODS: We are conducting an ongoing phase 3 trial involving adults with biopsy-confirmed NASH and a fibrosis stage of F1B, F2, or F3 (stages range from F0 [no fibrosis] to F4 [cirrhosis]). Patients were randomly assigned in a 1:1:1 ratio to receive once-daily resmetirom at a dose of 80 mg or 100 mg or placebo. The two primary end points at week 52 were NASH resolution (including a reduction in the nonalcoholic fatty liver disease [NAFLD] activity score by ≥2 points; scores range from 0 to 8, with higher scores indicating more severe disease) with no worsening of fibrosis, and an improvement (reduction) in fibrosis by at least one stage with no worsening of the NAFLD activity score. RESULTS: Overall, 966 patients formed the primary analysis population (322 in the 80-mg resmetirom group, 323 in the 100-mg resmetirom group, and 321 in the placebo group). NASH resolution with no worsening of fibrosis was achieved in 25.9% of the patients in the 80-mg resmetirom group and 29.9% of those in the 100-mg resmetirom group, as compared with 9.7% of those in the placebo group (P<0.001 for both comparisons with placebo). Fibrosis improvement by at least one stage with no worsening of the NAFLD activity score was achieved in 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group, as compared with 14.2% of those in the placebo group (P<0.001 for both comparisons with placebo). The change in low-density lipoprotein cholesterol levels from baseline to week 24 was -13.6% in the 80-mg resmetirom group and -16.3% in the 100-mg resmetirom group, as compared with 0.1% in the placebo group (P<0.001 for both comparisons with placebo). Diarrhea and nausea were more frequent with resmetirom than with placebo. The incidence of serious adverse events was similar across trial groups: 10.9% in the 80-mg resmetirom group, 12.7% in the 100-mg resmetirom group, and 11.5% in the placebo group. CONCLUSIONS: Both the 80-mg dose and the 100-mg dose of resmetirom were superior to placebo with respect to NASH resolution and improvement in liver fibrosis by at least one stage. (Funded by Madrigal Pharmaceuticals; MAESTRO-NASH ClinicalTrials.gov number, NCT03900429.).
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Harrison, S. A., Bédossa, P., Guy, C. D., Schattenberg, J. M., Loomba, R. S., Taub, R. A., Labriola, D., Moussa, S. E., Neff, G. W., Rinella, M. E., Anstee, Q. M., Abdelmalek, M. F., Younossi, Z. M., Baum, S. J., Francque, S., Charlton, M., Newsome, P. N., Lanthier, N., Schiefke, I., … Ratziu, V. (2024). A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. New England Journal of Medicine, 390(6), 497–509. https://doi.org/10.1056/nejmoa2309000
Harrison, Stephen A., et al. "A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis." New England Journal of Medicine, vol. 390, no. 6, 2024, pp. 497–509, https://doi.org/10.1056/nejmoa2309000.
Harrison, Stephen A., Pierre Bédossa, Cynthia D. Guy, Jörn Markus Schattenberg, Rohit Seth Loomba, Rebecca A. Taub, Dominic Labriola, et al. "A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis." New England Journal of Medicine 390, no. 6 (2024): 497–509. https://doi.org/10.1056/nejmoa2309000.
Harrison S. A., Bédossa P., Guy C. D. [и др.] A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis // New England Journal of Medicine. — 2024. — Vol. 390, № 6. — P. 497–509. — URL: https://doi.org/10.1056/nejmoa2309000
@article{harrison2024phase,
title = {{A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis}},
author = {Stephen A. Harrison and Pierre Bédossa and Cynthia D. Guy and Jörn Markus Schattenberg and Rohit Seth Loomba and Rebecca A. Taub and Dominic Labriola and Sam E. Moussa and Guy W. Neff and Mary Eugenia Rinella and Quentin Mark Anstee and Manal F. Abdelmalek and Zobair M. Younossi and Seth J. Baum and Sven Francque and Michael Charlton and Philip Noel Newsome and Nicolas Lanthier and Ingolf Schiefke and Alessandra Mangia and Juan Manuel Pericàs and Rashmee Patil and Arun Jayant Sanyal and Mazen Noureddin and Meena B. Bansal and Naim Alkhouri and Laurent Castéra and Madhavi Rudraraju and Vlad Ratziu},
journal = {New England Journal of Medicine},
year = {2024},
volume = {390},
number = {6},
pages = {497--509},
doi = {10.1056/nejmoa2309000},
url = {https://doi.org/10.1056/nejmoa2309000}
}TY - JOUR AU - Harrison, Stephen A. AU - Bédossa, Pierre AU - Guy, Cynthia D. AU - Schattenberg, Jörn Markus AU - Loomba, Rohit Seth AU - Taub, Rebecca A. AU - Labriola, Dominic AU - Moussa, Sam E. AU - Neff, Guy W. AU - Rinella, Mary Eugenia AU - Anstee, Quentin Mark AU - Abdelmalek, Manal F. AU - Younossi, Zobair M. AU - Baum, Seth J. AU - Francque, Sven AU - Charlton, Michael AU - Newsome, Philip Noel AU - Lanthier, Nicolas AU - Schiefke, Ingolf AU - Mangia, Alessandra AU - Pericàs, Juan Manuel AU - Patil, Rashmee AU - Sanyal, Arun Jayant AU - Noureddin, Mazen AU - Bansal, Meena B. AU - Alkhouri, Naim AU - Castéra, Laurent AU - Rudraraju, Madhavi AU - Ratziu, Vlad TI - A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis JO - New England Journal of Medicine VL - 390 IS - 6 SP - 497 EP - 509 PY - 2024 DA - 2024/02/07 DO - 10.1056/nejmoa2309000 UR - https://doi.org/10.1056/nejmoa2309000 ER -
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