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Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial
Zobair M Younossi ,
Vlad Ratziu ,
Rohit Loomba ,
Mary Rinella ,
Quentin M Anstee ,
Zachary Goodman ,
Pierre Bedossa ,
Andreas Geier ,
Susanne Beckebaum ,
Philip N Newsome ,
David Sheridan ,
Muhammad Y Sheikh ,
James Trotter ,
Whitfield Knapple ,
Eric Lawitz ,
Manal F Abdelmalek ,
Kris V Kowdley ,
Aldo J Montano-Loza ,
Jerome Boursier ,
Philippe Mathurin ,
Elisabetta Bugianesi ,
Giuseppe Mazzella ,
Antonio Olveira ,
Helena Cortez-Pinto ,
Isabel Graupera ,
David Orr ,
Lise Lotte Gluud ,
Jean-Francois Dufour ,
David Shapiro ,
Jason Campagna ,
Luna Zaru ,
Leigh MacConell ,
Reshma Shringarpure ,
Stephen Harrison ,
Arun J Sanyal ,
Manal Abdelmalek ,
Gary Abrams ,
Humberto Aguilar ,
Aijaz Ahmed ,
Elmar Aigner ,
Guruprasad Aithal ,
Aftab Ala ,
William Alazawi ,
Agustin Albillos ,
Michael Allison ,
Sfa Al-Shamma ,
Raul Andrade ,
Pietro Andreone ,
Mario Angelico ,
Victor Ankoma-Sey ,
Quentin Anstee ,
Rodolphe Anty ,
Victor Araya ,
Juan Ignacio Arenas Ruiz ,
Perttu Arkkila ,
Marty Arora ,
Tarik Asselah ,
Jennifer Au ,
Oyekoya Ayonrinde ,
Robert James Bailey ,
Maya Balakrishnan ,
Kiran Bambha ,
Meena Bansal ,
Sidney Barritt ,
John Bate ,
Jorge Beato ,
Susanne Beckebaum ,
Jaideep Behari ,
Pablo Bellot ,
Ziv Ben Ari ,
Michael Bennett ,
Marina Berenguer ,
Benedetta Terziroli Beretta-Piccoli ,
Thomas Berg ,
Maurizio Bonacini ,
Lucia Bonet ,
Brian Borg ,
Marc Bourliere ,
Jerome Boursier ,
William Bowman ,
David Bradley ,
Marija Brankovic ,
Marius Braun ,
Jean-Pierre Bronowicki ,
Savino Bruno ,
Elisabetta Bugianesi ,
Cindy Cai ,
José Luis Calleja Panero ,
Elizabeth Carey ,
Michal Carmiel ,
Jose Antonio Carrión ,
Matthew Cave ,
Cristina Chagas ,
Tawfik Chami ,
Alan Chang ,
Allan Coates ,
Jeremy Cobbold ,
Kathleen Corey ,
Lynsey Corless ,
Helena Cortez-Pinto ,
Javier Crespo ,
Oscar Cruz Pereira ,
Victor de Ledinghen ,
Andrew deLemos ,
Moises Diago ,
Jean-François Dufour ,
Predrag Dugalic ,
Winston Dunn ,
Magby Elkhashab ,
Michael Epstein ,
Maria Desamparados Escudero-Garcia ,
Ohad Etzion ,
Larry Evans ,
Robert Falcone ,
Conrado Fernandez ,
Jose Ferreira ,
Scott Fink ,
Kevin Finnegan ,
Roberto Firpi-Morell ,
Annarosa Floreani ,
Thierry Fontanges ,
Ryan Ford ,
Ewan Forrest ,
Andrew Fowell ,
Anna Ludovica Fracanzani ,
Sven Francque ,
Bradley Freilich ,
Juan Frias ,
Michael Fuchs ,
Javier Fuentes ,
Michael Galambos ,
Juan Gallegos ,
Anja Geerts ,
Andreas Geier ,
Jacob George ,
Maged Ghali ,
Reem Ghalib ,
Pierre Gholam ,
Pere Gines ,
Norman Gitlin ,
Lise Lotte Gluud ,
Tobias Goeser ,
John Goff ,
Stuart Gordon ,
Frederic Gordon ,
Odile Goria ,
Shaun Greer ,
Alla Grigorian ,
Henning Gronbaek ,
Maeva Guillaume ,
Naresh Gunaratnam ,
Dina Halegoua-De Marzio ,
Bilal Hameed ,
Stephanie Hametner ,
James Hamilton ,
Stephen Harrison ,
Marek Hartleb ,
Tarek Hassanein ,
Dieter Häussinger ,
Paul Hellstern ,
Robert Herring ,
Eva Heurich ,
Christophe Hezode ,
Holger Hinrichsen ,
Peter Holland Fischer ,
Yves Horsmans ,
Jonathan Huang ,
Antoine Jakiche ,
Lennox Jeffers ,
Blake Jones ,
Rosa Jorge ,
Francisco Jorquera ,
Alisan Kahraman ,
Kelly Kaita ,
Nicholas Karyotakis ,
Zeid Kayali ,
Stergios Kechagias ,
Thomas Kepczyk ,
Mandana Khalili ,
Hicham Khallafi ,
Johannes Kluwe ,
Whitfield Knapple ,
Anita Kohli ,
Kevin Korenblat ,
Kris Kowdley ,
Aleksander Krag ,
Richard Krause ,
Andreas Kremer ,
Karen Krok ,
Miodrag Krstic ,
Marcelo Kugelmas ,
Sonal Kumar ,
Damien Labarriere ,
Michelle Lai ,
Pietro Lampertico ,
Eric Lawitz ,
Alice Lee ,
Vincent Leroy ,
Steven Lidofsky ,
Tina Huey Lim ,
Joseph Lim ,
Donald Lipkis ,
Ester Little ,
Amadeo Lonardo ,
Michelle Long ,
Rohit Loomba ,
Yoav Lurie ,
Guilherme Macedo ,
Mihály Makara ,
Benedict Maliakkal ,
Michael Manns ,
Pinelopi Manousou ,
Parvez Mantry ,
Giulio Marchesini ,
Carla Marinho ,
Paul Marotta ,
Hanns-Ulrich Marschall ,
Philippe Mathurin ,
Marlyn Mayo ,
Giuseppe Mazzella ,
Mark McCullen ,
William McLaughlin ,
Raphael Merriman ,
Apurva Modi ,
Esther Molina ,
Aldo Montano-Loza ,
Carlos Monteverde ,
Sulleman Moreea ,
Christophe Moreno ,
Filomena Morisco ,
Abdullah Mubarak ,
Beat Muellhaupt ,
Sandeep Mukherjee ,
Tobias Müller ,
Aleksandar Nagorni ,
Jahnavi Naik ,
Guy Neff ,
Moises Nevah ,
Philip Newsome ,
Eric Nguyen-Khac ,
Mazen Noureddin ,
Jude Oben ,
Antonio Olveira ,
Hans Orlent ,
David Orr ,
James Orr ,
Grisell Ortiz-Lasanta ,
Violaine Ozenne ,
Prashant Pandya ,
Angelo Paredes ,
James Park ,
Joykumar Patel ,
Keyur Patel ,
Merle Uta ,
Heather Patton ,
Markus Peck-Radosavljevic ,
Salvatore Petta ,
Stephen Pianko ,
Anna Piekarska ,
Neville Pimstone ,
Paul Pockros ,
Stanislas Pol ,
Michael Porayko ,
John Poulos ,
David Pound ,
Joe Pouzar ,
Jose Presa Ramos ,
Nikolaos Pyrsopoulos ,
Nila Rafiq ,
Kate Muller ,
Alnoor Ramji ,
Vlad Ratziu ,
Ravi Ravinuthala ,
Chakradhar Reddy ,
Gautham Reddy K G ,
K. Rajender Reddy K R ,
Frederic Regenstein ,
Robert Reindollar ,
Andres Riera ,
Mary Rinella ,
Jose Rivera Acosta ,
Geert Robaeys ,
Stuart Roberts ,
Federico Rodriguez-Perez ,
Manuel Romero-Gomez ,
Raymond Rubin ,
Mariagrazia Rumi ,
Simon Rushbrook ,
Christian Rust ,
Michael Ryan ,
Rifaat Safadi ,
Adnan Said ,
Kimmo Salminen ,
Didier Samuel ,
John Santoro ,
Arun Sanyal ,
Souvik Sarkar ,
Cynthia Schaeffer ,
Jörn Schattenberg ,
Ingolf Schiefke ,
Eugene Schiff ,
Wolfgang Schmidt ,
Jeffrey Schneider ,
Jeoffrey Schouten ,
Michael Schultz ,
Giada Sebastiani ,
David Semela ,
Thomas Sepe ,
Aasim Sheikh ,
Muhammad Sheikh ,
David Sheridan ,
Kenneth Sherman ,
Oren Shibolet ,
Mitchell Shiffman ,
Asma Siddique ,
Cyril Sieberhagen ,
Samuel Sigal ,
Katarzyna Sikorska ,
Krzysztof Simon ,
Marie Sinclair ,
Richard Skoien ,
Joel Solis ,
Siddharth Sood ,
Bob Souder ,
James Spivey ,
Per Stal ,
Laura Stinton ,
Simone Strasser ,
Petar Svorcan ,
Gyongzi Szabo ,
Andrew Talal ,
Edward Tam ,
Brent Tetri ,
Paul Thuluvath ,
Hillel Tobias ,
Krzysztof Tomasiewicz ,
Dawn Torres ,
Michael Trauner ,
Christian Trautwein ,
James Trotter ,
Emanuel Tsochatzis ,
Esther Unitt ,
Victor Vargas ,
Istvan Varkonyi ,
Ella Veitsman ,
Umberto Vespasiani Gentilucci ,
David Victor ,
John Vierling ,
Catherine Vincent ,
Aron Vincze ,
Manfred von der Ohe ,
Natasha Von Roenn ,
Raj Vuppalanchi ,
Michael Waters ,
Kymberly Watt ,
Martin Weltman ,
Amanda Wieland ,
Gregory Wiener ,
Alonzo Williams A ,
Jeffrey Williams J ,
Jason Wilson ,
Maria Yataco ,
Eric Yoshida ,
Ziad Younes ,
Liyun Yuan ,
Adam Zivony ,
Donald Zogg ,
Heinz Zoller ,
Fabien Zoulim ,
Eli Zuckerman ,
Massimo Zuin
December 2019
December 2019
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Abstract
<p class="first" id="d4001751e570">Non-alcoholic steatohepatitis (NASH) is a common
type of chronic liver disease that
can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been
shown to improve the histological features of NASH. Here we report results from a
planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH.
</p>