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Page 1
Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science.
Fouad Y, Palmer M, Chen M, Regev A, Banerjee R, Myers R, Riccio R, Torstenson R, Younes R, Arora PS, Landgren H, Karsdal MA, Blake M, Shapiro DA, Gruss HJ, Sheikh MY, Attia D, Bollipo S, Smith AD, Freilich B, Gish RG, Schuppan D. Fouad Y, et al. Among authors: sheikh my. J Clin Transl Hepatol. 2022 Apr 28;10(2):374-382. doi: 10.14218/JCTH.2021.00408. Epub 2021 Oct 22. J Clin Transl Hepatol. 2022. PMID: 35528969 Free PMC article. Review.
A randomized, placebo-controlled trial of emricasan in patients with NASH and F1-F3 fibrosis.
Harrison SA, Goodman Z, Jabbar A, Vemulapalli R, Younes ZH, Freilich B, Sheikh MY, Schattenberg JM, Kayali Z, Zivony A, Sheikh A, Garcia-Samaniego J, Satapathy SK, Therapondos G, Mena E, Schuppan D, Robinson J, Chan JL, Hagerty DT, Sanyal AJ. Harrison SA, et al. Among authors: sheikh my. J Hepatol. 2020 May;72(5):816-827. doi: 10.1016/j.jhep.2019.11.024. Epub 2019 Dec 27. J Hepatol. 2020. PMID: 31887369 Clinical Trial.
Volixibat in adults with non-alcoholic steatohepatitis: 24-week interim analysis from a randomized, phase II study.
Newsome PN, Palmer M, Freilich B, Sheikh MY, Sheikh A, Sarles H, Herring R, Mantry P, Kayali Z, Hassanein T, Lee HM, Aithal GP; Volixibat in Adults study group. Newsome PN, et al. Among authors: sheikh my. J Hepatol. 2020 Aug;73(2):231-240. doi: 10.1016/j.jhep.2020.03.024. Epub 2020 Mar 29. J Hepatol. 2020. PMID: 32234329 Free article. Clinical Trial.
Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial.
Harrison SA, Abdelmalek MF, Neff G, Gunn N, Guy CD, Alkhouri N, Bashir MR, Freilich B, Kohli A, Khazanchi A, Sheikh MY, Leibowitz M, Rinella ME, Siddiqui MS, Kipnes M, Moussa SE, Younes ZH, Bansal M, Baum SJ, Borg B, Ruane PJ, Thuluvath PJ, Gottwald M, Khan M, Chen C, Melchor-Khan L, Chang W, DePaoli AM, Ling L, Lieu HD. Harrison SA, et al. Among authors: sheikh my. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):603-616. doi: 10.1016/S2468-1253(22)00017-6. Epub 2022 Mar 21. Lancet Gastroenterol Hepatol. 2022. PMID: 35325622 Clinical Trial.
Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis.
Sanyal AJ, Ratziu V, Loomba R, Anstee QM, Kowdley KV, Rinella ME, Sheikh MY, Trotter JF, Knapple W, Lawitz EJ, Abdelmalek MF, Newsome PN, Boursier J, Mathurin P, Dufour JF, Berrey MM, Shiff SJ, Sawhney S, Capozza T, Leyva R, Harrison SA, Younossi ZM. Sanyal AJ, et al. Among authors: sheikh my. J Hepatol. 2023 Nov;79(5):1110-1120. doi: 10.1016/j.jhep.2023.07.014. Epub 2023 Jul 28. J Hepatol. 2023. PMID: 37517454 Free article.
A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis.
Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericàs JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. Harrison SA, et al. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000. N Engl J Med. 2024. PMID: 38324483 Clinical Trial.
Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial.
Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Younossi ZM, et al. Among authors: sheikh my. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5. Lancet. 2019. PMID: 31813633 Free article. Clinical Trial.
A phase 2, randomized, double-blind, placebo-controlled study of GS-9450 in subjects with nonalcoholic steatohepatitis.
Ratziu V, Sheikh MY, Sanyal AJ, Lim JK, Conjeevaram H, Chalasani N, Abdelmalek M, Bakken A, Renou C, Palmer M, Levine RA, Bhandari BR, Cornpropst M, Liang W, King B, Mondou E, Rousseau FS, McHutchison J, Chojkier M. Ratziu V, et al. Among authors: sheikh my. Hepatology. 2012 Feb;55(2):419-28. doi: 10.1002/hep.24747. Epub 2011 Dec 14. Hepatology. 2012. PMID: 22006541 Free PMC article. Clinical Trial.
60 results