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 F. 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 M. Anstee; Rodolphe Anty; V Araya; Ruiz JI Arenas; P Arkkila; M Arora; T Asselah; J Au; O Ayonrinde; RJ Bailey; M Balakrishnan; K Bambha; M Bansal; S Barritt; J Bate; J Beato; Susanne Beckebaum; J Behari; P Bellot; Ari Z Ben; M Bennett; M Berenguer; BT Beretta-Piccoli; T Berg; M Bonacini; L Bonet; B Borg; M Bourliere; Jerome Boursier; W Bowman; D Bradley; M Brankovic; M Braun; J-P Bronowicki; S Bruno; Elisabetta Bugianesi; C Cai; Panero JL Calleja

doi:10.1016/s0140-6736(19)33041-7

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 F. 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 M. Anstee, Rodolphe Anty, V Araya, Ruiz JI Arenas, P Arkkila, M Arora, T Asselah, J Au, O Ayonrinde, RJ Bailey, M Balakrishnan, K Bambha, M Bansal, S Barritt, J Bate, J Beato, Susanne Beckebaum, J Behari, P Bellot, Ari Z Ben, M Bennett, M Berenguer, BT Beretta-Piccoli, T Berg, M Bonacini, L Bonet, B Borg, M Bourliere, Jerome Boursier, W Bowman, D Bradley, M Brankovic, M Braun, J-P Bronowicki, S Bruno, Elisabetta Bugianesi, C Cai, Panero JL Calleja

^*Corresponding author for this work

Peninsula Medical School

Inova Health System
Sorbonne Université
University of California at San Diego
Northwestern University
Newcastle University
Newcastle upon Tyne Hospitals NHS Foundation Trust
Assistance publique – Hôpitaux de Paris
University of Würzburg
St. Josef-Krankenhaus Kupferdreh
University Hospitals Birmingham NHS Foundation Trust
University of Birmingham
University Hospitals Plymouth NHS Trust
Fresno Clinical Research Center
Baylor Health Care System
Arkansas Gastroenterology
University of Texas Health Science Center at San Antonio
Duke University
Swedish Liver Center
University of Alberta
Université d'Angers
Université de Lille
University of Turin
University of Bologna
Universidad Autónoma de Madrid
University of Lisbon
August Pi i Sunyer Biomedical Research Institute
Centro de Investigación Biomédica en Red
University of Barcelona
Auckland District Health Board
University of Copenhagen
University of Bern
Intercept Pharmaceuticals
Pinnacle Clinical Research
Virginia Commonwealth University

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Original language	English
Number of pages	0
Journal	The Lancet
Volume	0
Issue number	0
Early online date	5 Dec 2019
DOIs	https://doi.org/10.1016/s0140-6736(19)33041-7
Publication status	Published - Dec 2019

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Younossi (Lancet 2019 Resub Appendix) REGENERATE IA (24Oct2019)FInal SubmittedOther version, 648 KB
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Younossi, Z. M., Ratziu, V., Loomba, R., Rinella, M., Anstee, Q. M., Goodman, Z., Bedossa, P., Geier, A., Beckebaum, S., Newsome, P. N., Sheridan, D., Sheikh, M. Y., Trotter, J., Knapple, W., Lawitz, E., Abdelmalek, M. F., Kowdley, K. V., Montano-Loza, A. J., Boursier, J., ... Calleja, P. JL. (2019). Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. The Lancet, 0(0). https://doi.org/10.1016/s0140-6736(19)33041-7

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title = "Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial",

author = "Younossi, \{Zobair M.\} and Vlad Ratziu and Rohit Loomba and Mary Rinella and Anstee, \{Quentin M.\} and Zachary Goodman and Pierre Bedossa and Andreas Geier and Susanne Beckebaum and Newsome, \{Philip N.\} and David Sheridan and Sheikh, \{Muhammad Y.\} and James Trotter and Whitfield Knapple and Eric Lawitz and Abdelmalek, \{Manal F.\} and Kowdley, \{Kris V.\} and Montano-Loza, \{Aldo J.\} and Jerome Boursier and Philippe Mathurin and Elisabetta Bugianesi and Giuseppe Mazzella and Antonio Olveira and Helena Cortez-Pinto and Isabel Graupera and David Orr and Gluud, \{Lise Lotte\} and Dufour, \{Jean Francois\} and David Shapiro and Jason Campagna and Luna Zaru and Leigh MacConell and Reshma Shringarpure and Stephen Harrison and Sanyal, \{Arun J.\} and Abdelmalek, \{Manal F.\} and Gary Abrams and Humberto Aguilar and Aijaz Ahmed and Elmar Aigner and Guruprasad Aithal and Aftab Ala and William Alazawi and Agustin Albillos and Michael Allison and Sfa Al-Shamma and Raul Andrade and Pietro Andreone and Mario Angelico and Victor Ankoma-Sey and Anstee, \{Quentin M.\} and Rodolphe Anty and V Araya and Arenas, \{Ruiz JI\} and P Arkkila and M Arora and T Asselah and J Au and O Ayonrinde and RJ Bailey and M Balakrishnan and K Bambha and M Bansal and S Barritt and J Bate and J Beato and Susanne Beckebaum and J Behari and P Bellot and Ben, \{Ari Z\} and M Bennett and M Berenguer and BT Beretta-Piccoli and T Berg and M Bonacini and L Bonet and B Borg and M Bourliere and Jerome Boursier and W Bowman and D Bradley and M Brankovic and M Braun and J-P Bronowicki and S Bruno and Elisabetta Bugianesi and C Cai and Calleja, \{Panero JL\}",

year = "2019",

month = dec,

doi = "10.1016/s0140-6736(19)33041-7",

language = "English",

volume = "0",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "0",

}

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, Abdelmalek, MF, Abrams, G, Aguilar, H, Ahmed, A, Aigner, E, Aithal, G, Ala, A, Alazawi, W, Albillos, A, Allison, M, Al-Shamma, S, Andrade, R, Andreone, P, Angelico, M, Ankoma-Sey, V, Anstee, QM, Anty, R, Araya, V, Arenas, RJI, Arkkila, P, Arora, M, Asselah, T, Au, J, Ayonrinde, O, Bailey, RJ, Balakrishnan, M, Bambha, K, Bansal, M, Barritt, S, Bate, J, Beato, J, Beckebaum, S, Behari, J, Bellot, P, Ben, AZ, Bennett, M, Berenguer, M, Beretta-Piccoli, BT, Berg, T, Bonacini, M, Bonet, L, Borg, B, Bourliere, M, Boursier, J, Bowman, W, Bradley, D, Brankovic, M, Braun, M, Bronowicki, J-P, Bruno, S, Bugianesi, E, Cai, C & Calleja, PJL 2019, 'Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial', The Lancet, vol. 0, no. 0. https://doi.org/10.1016/s0140-6736(19)33041-7

TY - JOUR

T1 - Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

AU - Younossi, Zobair M.

AU - Ratziu, Vlad

AU - Loomba, Rohit

AU - Rinella, Mary

AU - Anstee, Quentin M.

AU - Goodman, Zachary

AU - Bedossa, Pierre

AU - Geier, Andreas

AU - Beckebaum, Susanne

AU - Newsome, Philip N.

AU - Sheridan, David

AU - Sheikh, Muhammad Y.

AU - Trotter, James

AU - Knapple, Whitfield

AU - Lawitz, Eric

AU - Abdelmalek, Manal F.

AU - Kowdley, Kris V.

AU - Montano-Loza, Aldo J.

AU - Boursier, Jerome

AU - Mathurin, Philippe

AU - Bugianesi, Elisabetta

AU - Mazzella, Giuseppe

AU - Olveira, Antonio

AU - Cortez-Pinto, Helena

AU - Graupera, Isabel

AU - Orr, David

AU - Gluud, Lise Lotte

AU - Dufour, Jean Francois

AU - Shapiro, David

AU - Campagna, Jason

AU - Zaru, Luna

AU - MacConell, Leigh

AU - Shringarpure, Reshma

AU - Harrison, Stephen

AU - Sanyal, Arun J.

AU - Abdelmalek, Manal F.

AU - Abrams, Gary

AU - Aguilar, Humberto

AU - Ahmed, Aijaz

AU - Aigner, Elmar

AU - Aithal, Guruprasad

AU - Ala, Aftab

AU - Alazawi, William

AU - Albillos, Agustin

AU - Allison, Michael

AU - Al-Shamma, Sfa

AU - Andrade, Raul

AU - Andreone, Pietro

AU - Angelico, Mario

AU - Ankoma-Sey, Victor

AU - Anstee, Quentin M.

AU - Anty, Rodolphe

AU - Araya, V

AU - Arenas, Ruiz JI

AU - Arkkila, P

AU - Arora, M

AU - Asselah, T

AU - Au, J

AU - Ayonrinde, O

AU - Bailey, RJ

AU - Balakrishnan, M

AU - Bambha, K

AU - Bansal, M

AU - Barritt, S

AU - Bate, J

AU - Beato, J

AU - Beckebaum, Susanne

AU - Behari, J

AU - Bellot, P

AU - Ben, Ari Z

AU - Bennett, M

AU - Berenguer, M

AU - Beretta-Piccoli, BT

AU - Berg, T

AU - Bonacini, M

AU - Bonet, L

AU - Borg, B

AU - Bourliere, M

AU - Boursier, Jerome

AU - Bowman, W

AU - Bradley, D

AU - Brankovic, M

AU - Braun, M

AU - Bronowicki, J-P

AU - Bruno, S

AU - Bugianesi, Elisabetta

AU - Cai, C

AU - Calleja, Panero JL

PY - 2019/12

Y1 - 2019/12

UR - https://pearl.plymouth.ac.uk/pms-research/177/

U2 - 10.1016/s0140-6736(19)33041-7

DO - 10.1016/s0140-6736(19)33041-7

M3 - Article

SN - 0140-6736

VL - 0

JO - The Lancet

JF - The Lancet

IS - 0

ER -

Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

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