A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis
| Title: | A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis |
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| Authors: | Harrison S. A.; Bedossa P.; Guy C. D.; Schattenberg J. M.; Loomba R.; Taub R.; Labriola D.; Moussa S. E.; Neff G. W.; Rinella M. E.; Anstee Q. M.; Abdelmalek M. F.; Younossi Z.; Baum S. J.; Francque S.; Charlton M. R.; Newsome P. N.; Lanthier N.; Schiefke I.; Mangia A.; Pericas J. M.; Patil R.; Sanyal A. J.; Noureddin M.; Bansal M. B.; Alkhouri N.; Castera L.; Rudraraju M.; Ratziu V. John Bate; Mark Danta; Lay Gan; Jacob George; Mohammad Haque; Alexander Hodge; Nicholas Kontorinis; Christopher Leung; Stuart Roberts; Richard Skoien; Siddharth Sood; Simone Strasser; Martin Weltman; Stephanie Hametner-Schreil; Harald Hofer; Bertram Hölzl; Bernhard Ludvik; Andreas Maieron; Markus Peck-Radosavljevic; Michael Trauner; Jochen Decaestecker; Sven Francque; Anja Geerts; Sebastien Kindt; Wim Laleman; Nicolas Lanthier; Luc Lasser; Christophe Moreno; Geert Robaeys; Christophe Van Steenkiste; Harpreet Bajaj; Meredith Borman; Natasha Chandok; Magdy El Khashab; Hughie Fraser; Hin Ko; Aldo Montano-Loza; Keyur Patel; Marco Puglia; Eric Yoshida; Armand Abergel; Edouard Bardou-Jacquet; Jerome Boursier; Jean-Pierre Bronowicki; Christophe Bureau; Laurent Castera; Vincent Di Martino; François Habersetzer; Dominique Larrey; Véronique Loustaud Ratti; Philippe Mathurin; Marianne Maynard-Muet; Eric Nguyen-Khac; Stanislas Pol; Vlad Ratziu; Dominique Roulot; Lawrence Serfaty; Albert Tran; Anne Varaut; Keikawus Arastéh; Katrin Arelin; Christel Contzen; Münevver Demir; Yvonne Doerffel; Andreas Geier; Patrick Ingiliz; Frank Lammert; Maria Lehretz; Jörn Schattenberg; Ingolf Schiefke; Natalia Schüte; Stefan Zeuzem; Tivadar Banyai; Miklós Lesch; Mihaly Makara; József Nemes; Tamás Nyéky; Márta Varga; István Zsolt Várkonyi; Ziv Ben-Ari; Marius Braun; Adi Francis; Helena Katchman; Yoav Lurie; Assy Nimer; Rifaat Safadi; Ella Veitsman; David Yardeni; Eli Zuckerman; Mario Angelico; Maria Del Ben; Stefano Fagiuoli; Pietro Lampertico; Alessandra Mangia; Fabio Marra; Alessandro Mattina; Luca Miele; Salvatore Peta; Mario Pirisi; Giovanni Raimondo; Giuliano Rizzardini; Maurizia Rossana Bruneto; Alma Laura Ladron de Guevara; Laura Esthela Cisneros Garza; José Rodríguez Chávez; Jose Flores Figueroa; Mauricio Castillo Barradas; Juan M Pericàs; Jesús M Rivera-Esteban; Marta Casado Martín; Luis Ibañez Samaniego; Isabel Conde; Jose Luis Calleja Panero; Xavier Torras Colell; Francisco Moises Diago Madrid; Javier Crespo Garcia; Juan Turnes Vazquez; Manuel Romero Gomez; Montserrat Garcia Retortillo; Agustin Albilos Martinez; Annalisa Berzigotti; Jean Francois Dufour; Lorenzo Magenta; Beat Müllhaupt; Daniel Abales; William Alazawi; Michael Allison; Quentin Anstee; Sandra Connell; Pratiksha Dokhe; Susannah Eyre; Daniel Forton; Andrew Fowell; Mathew Foxton; Madhu Gowda; Shalini Iyengar; Christina Kyriakidou; Chin Lye Ch'ng; Pinelopi Manousou; Roger McCorry; Philip Newsome; Thomas Pembroke; Mahadev Ramjee; Stephen Ryder; Arun Shankar; David Sheridan; Cyril Sieberhagen; Hawys Thomas; Emmanouil Tsochatzis; Manal Abdelmalek; Michael Adams; Victor Ankoma-Sey; Samir Arora; Vivek Awasty; Jennifer Bashour; Seth Baum; Anuj Bhargava; Brian Borg; Stephen Caldwell; Cornell Calinescu; Shekhar Challa; Michael Charlton; Christopher Christensen; Jeffery DeGrauw; Donna Desantis; Clarence Dunn; Winston Dunn; Michael Fine; Roberto Firpi-Morell; Bradley Freilich; Michael Fuchs; Marisela Gonzalez; Nadege Gunn; Paul Hellstern Jr; Stanley Hsia; Jason Huffman; Antoine Jakiche; George James; Robert Jenders; William Jennings; Thomas Kepczyk; Arun Khazanchi; Whitfield Knapple; Anita Kohli; Joseph Kosinski; Kris Kowdley; Marcelo Kugelmas; Eric Lawitz; Kurt Lesh; Kathryn Lucas; Richard Manch; Ravi Mani; Kevin Merkes; Robert Meyer; Apurva Modi; Ann Moore; Amilcar Morales; Abdullah Mubarak; Joseph Newberg; Grisell Ortiz Lasanta; Mangesh Pagadala; Rashmee Patil; John Poulos; Ravi Ravinuthala; Gary Reiss; Michele Reynolds; Mary Rinella; Peter Ruane; John Scot; Aasim Sheikh; Muhammad Sheikh; Mitchell Shiffman; Gerald Shockey; Dan Streja; Parvin Syal; Brent Tetri; George Therapondos; Dawn Torres; James Troter; Gregg Wendorf; Alexander White; Johnny White; Mark Wilson; Ziad Younes |
| Contributors: | S. A., Harrison; P., Bedossa; C. D., Guy; J. M., Schattenberg; R., Loomba; R., Taub; D., Labriola; S. E., Moussa; G. W., Neff; M. E., Rinella; Q. M., Anstee; M. F., Abdelmalek; Z., Younossi; S. J., Baum; S., Francque; M. R., Charlton; P. N., Newsome; N., Lanthier; I., Schiefke; A., Mangia; J. M., Perica; R., Patil; A. J., Sanyal; M., Noureddin; M. B., Bansal; N., Alkhouri; L., Castera; M., Rudraraju; John Bate, Ratziu V.; Danta, Mark; Gan, Lay; George, Jacob; Haque, Mohammad; Hodge, Alexander; Kontorinis, Nichola; Leung, Christopher; Roberts, Stuart; Skoien, Richard; Sood, Siddharth; Strasser, Simone; Weltman, Martin; Hametner-Schreil, Stephanie; Hofer, Harald; Hölzl, Bertram; Ludvik, Bernhard; Maieron, Andrea; Peck-Radosavljevic, Marku; Trauner, Michael; Decaestecker, Jochen; Francque, Sven; Geerts, Anja; Kindt, Sebastien; Laleman, Wim; Lanthier, Nicola; Lasser, Luc; Moreno, Christophe; Robaeys, Geert; Van Steenkiste, Christophe; Bajaj, Harpreet; Borman, Meredith; Chandok, Natasha; El Khashab, Magdy; Fraser, Hughie; Ko, Hin; Montano-Loza, Aldo; Patel, Keyur; Puglia, Marco; Yoshida, Eric; Abergel, Armand; Bardou-Jacquet, Edouard; Boursier, Jerome; Bronowicki, Jean-Pierre; Bureau, Christophe; Castera, Laurent; Di Martino, Vincent; Habersetzer, Françoi; Larrey, Dominique; Loustaud Ratti, Véronique; Mathurin, Philippe; Maynard-Muet, Marianne; Nguyen-Khac, Eric; Pol, Stanisla; Ratziu, Vlad; Roulot, Dominique; Serfaty, Lawrence; Tran, Albert; Varaut, Anne; Arastéh, Keikawu; Arelin, Katrin; Contzen, Christel; Demir, Münevver; Doerffel, Yvonne; Geier, Andrea; Ingiliz, Patrick; Lammert, Frank; Lehretz, Maria; Schattenberg, Jörn; Schiefke, Ingolf; Schüte, Natalia; Zeuzem, Stefan |
| Publisher Information: | MASSACHUSETTS MEDICAL SOC |
| Publication Year: | 2024 |
| Collection: | Università degli Studi di Messina: IRIS |
| Description: | 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 |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/38324483; info:eu-repo/semantics/altIdentifier/wos/WOS:001184460800023; volume:390; issue:6; firstpage:497; lastpage:509; numberofpages:13; journal:THE NEW ENGLAND JOURNAL OF MEDICINE; https://hdl.handle.net/11570/3296750 |
| DOI: | 10.1056/NEJMoa2309000 |
| Availability: | https://hdl.handle.net/11570/3296750; https://doi.org/10.1056/NEJMoa2309000 |
| Accession Number: | edsbas.80134AFD |
| Database: | BASE |