← Back to cohort
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 E. Rinella, Quentin M. Anstee, Zachary Goodman, Pierre Bédossa, Andreas Geier, Susanne Beckebaum, Philip N. Newsome, David Sheridan, Muhammad Y. Sheikh, James F. Trotter, W Knapple, Eric Lawitz, Manal F. Abdelmalek, Kris V. Kowdley, Aldo J. Montaño‐Loza, Jérôme Boursier, Philippe Mathurin, Elisabetta Bugianesi, G. Mazzella, Antonio Olveira, Helena Cortez‐Pinto, Isabel Graupera, David Orr, Lise Lotte Gluud, Jean‐François Dufour, David E. Shapiro, Jason Campagna, Luna Zaru, Leigh MacConell, Reshma Shringarpure, Stephen A. Harrison, Arun J. Sanyal, Gary A. Abrams, Humberto Aguilar, Aijaz Ahmed, Elmar Aigner, Guruprasad P. Aithal, Aftab Ala, William Alazawi, Agustı́n Albillos, Michael Allison, Sfa Al-Shamma, Raúl J. Andrade, Pietro Andreoné, M. Angélico, Victor Ankoma‐Sey, Rodolphe Anty, Víctor Araya, Juan Ignacio Arenas Ruiz, Perttu Arkkila, Marty Arora, Tarik Asselah, Jennifer Au, Oyekoya T. Ayonrinde, Robert J. Bailey, Maya Balakrishnan, Kiran Bambha, Meena B. Bansal, Sidney Barritt, John Bate, Jorge Beato, Jaideep Behari, Pablo Bellot, Ziv Ben Ari, Michael Bennett, Marina Berenguer, Benedetta Terziroli Beretta‐Piccoli, Thomas Berg, Maurizio Bonacini, Lucía Bonet, Brian B. Borg, Marc Bourlière, William D. Bowman, David Bradley, Marija Branković, Marius Braun, Jean-Pierre Bronowicki, Savino Bruno, Cindy X. Cai, Amy Calderon, Elizabeth J. Carey, Michal Carmiel, J.A. Carrión, Matthew C. Cave, Cristina Chagas, Tawfik N. Chami, Alan K. Chang, Allan Coates, Jeremy Cobbold, Charlote Costentin, Kathleen E. Corey, Lynsey Corless, Javier Crespo, O. Pereira, Victor de Lédinghen, Andrew S. deLemos, M. Diago, Mamie Dong, Predrag Dugalić, Magby Elkhashab, Michael Epstein, Maria Desamparados Escudero-García, Ohad Etzion, Larry Evans, Robert E. Falcone, Conrado Fernández‐Rodríguez, José Carlos Ferreira, Scott Fink, Kevin T. Finnegan, Roberto Firpi-Morell, Annarosa Floreani, Thierry Fontanges, Ryan Ford, Ewan Forrest, Andrew Fowell, Anna Ludovica Fracanzani, Sven Francque, B. Freilich, Juan P. Frías, Michael Fuchs, Javier Fuentes, Michael Galambos, Juan Gallegos, Anja Geerts, Maged P. Ghali, Reem Ghalib, Pierre Gholam, Pere Ginès, Norman Gitlin, Tobias Goeser, John S. Goff, Stuart C. Gordon, Odile Goria, Shaun Greer, А В Григорян, Henning Grønbæk, Maéva Guillaume, Naresh T. Gunaratnam, Dina Halegoua‐De Marzio, Bilal Hameed, S 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, Hyder Hussaini, Antoine Jakiche, Lennox Jeffers, Blake Jones, Rosa Jorge, Francisco Jorquera, Shoba Joshi, Alişan Kahraman, Kelly Kaita, N C Karyotakis, Zeid Kayali, Stergios Kechagias, Thomas Kepczyk, Mandana Khalili, Hicham Khallafi, Johannes Kluwe, Anita Kohli, Kevin Korenblat, Aleksander Krag, Richard A. Krause, Andreas E. Kremer, Karen Krok, Miodrag Krstić, Marcelo Kugelmas, Sonal Kumar, Scott K. Kuwada, Damien Labarrière, Michelle Lai, Wim Laleman, Pietro Lampertico, Alice Lee, Vincent Leroy, Steven D. Lidofsky, Tina Huey Lim, Joseph K. Lim, Donald Lipkis, Ester C. Little, A. Di Lonardo, Michelle T. Long, Velimir A. Luketic, Yoav Lurie, Guilherme Macedo, Joana Magalhães, Mihály Makara, Benedict Maliakkal, Michael Manns, Pinelopi Manousou, Parvez Mantry, Giulio Marchesini, Carla Marinho, Paul Marotta, Hanns–Ulrich Marschall, Linda Sprague Martínez, Marlyn J. Mayo, M. McCullen, William McLaughlin, Uta Merle, Raphael B. Merriman, Apurva A. Modi, Esther Molina, Carlos Monteverde, A. Cardona, Sulleman Moreea, Christophe Moreno, Filomena Morisco, Abdullah Mubarak, Beat Muellhaupt, Sandeep Mukherjee, Tobias Müller, Aleksandar Nagorni, Jahnavi Naik, Guy Neff, Moises I. Nevah, Éric Nguyen-Khac, Mazen Noureddin, Jude A. Oben, Hans Orlent, James Orr, Grisell Ortiz‐Lasanta, Violaine Ozenne, Prashant Pandya, Angelo H. Paredes, James Park, Joykumar Patel, Keyur P. Patel, Sonali Paul, Heather Patton, Markus Peck‐Radosavljevic, Salvatore Petta, Stephen Pianko, Anna Piekarska, Neville R. Pimstone, Joseph R. Pisegna, Paul J. Pockros, Stanislas Pol, Michael K. Porayko, John Poulos, David Pound, Joe Pouzar, José Presa Ramos, Nikolaos Pyrsopoulos, Nila Rafiq, Kate Muller, Alnoor Ramji, Ravi Ravinuthala, Chakradhar Reddy, Gautham Reddy K G, K. Rajender Reddy K R, Frederic Regenstein, Robert Reindollar, Justin Reynolds, Andrés Ricardo Pérez‐Riera, Mary E. Rinella, Jose Rivera Acosta, Geert Robaeys, Stuart K. Roberts, Federico Rodríguez-Pérez, Sandor Romero, Manuel Romero‐Gómez, Raymond A. Rubin, Maria Grazia Rumi, Simon Rushbrook, Christian Rust, Michael Ryan, Rifaat Safadi, Adnan Said, Kimmo Salminen, Didier Samuel, J. Santoro, Souvik Sarkar, Cynthia Schaeffer, Jörn M. Schattenberg, Ingolf Schiefke, Eugene R. Schiff, Wolfgang E. Schmidt, Jeffrey Schneider, Jeoffrey Schouten, Michael Schultz, Giada Sebastiani, David Semela, Thomas Sepe, Aasim Sheikh, Muhammad Y. Sheikh, Kenneth E. Sherman, Oren Shibolet, Mitchell L. Shiffman, Asma Siddique, Cyril Sieberhagen, Samuel H. Sigal, Katarzyna Sikorska, Krzysztof Simon, Marie Sinclair, Richard Skoien, Joel Solis, Siddharth Sood, Bob Souder, James R. Spivey, Per Stål, Laura M. Stinton, Simone I. Strasser, Petar Svorcan, Gyongzi Szabo, Andrew H. Talal, Edward Tam, Brent A. Tetri, Paul J. Thuluvath, Hillel Tobias, Krzysztof Tomasiewicz, Dawn M. Torres, Albert Tran, Michael Trauner, Christian Trautwein, Esther Unitt, Vı́ctor Vargas, István Várkonyi, Ella Veitsman, Umberto Vespasiani‐Gentilucci, D. A. Victor, John M. Vierling, Catherine Vincent, Áron Vincze, Manfred von der Ohe, Natasha Von Roenn, Raj Vuppalanchi, Michael F. Waters, Kymberly D. Watt, Julia Wattacheril, Martin Weltman, Amanda Wieland, Gregory Wiener, Alonzo Williams A, Jeffrey Williams J, Jason Wilson, Maria Yataco, Eric M. Yoshida, Ziad Younes, Liyun Yuan, Adam Zivony, Donald L. Zogg, Heinz Zoller, Fabien Zoulim, Eli Zuckerman, Massimo Zuin
Bibliographic record
VenueThe Lancet · 2019
Typearticle
Languageen
FieldMedicine
TopicLiver Disease Diagnosis and Treatment
Canadian institutionsUniversity of Alberta
FundersAstraZenecaAllerganGilead SciencesServierNovartis PharmaNewcastle UniversityNovo NordiskAbbott LaboratoriesNational Institute for Health and Care ResearchGenentechArrowhead PharmaceuticalsCoherus BiosciencesIntercept PharmaceuticalsAlexion PharmaceuticalsMedpaceGlaxoSmithKlineNGM BiopharmaceuticalsBirmingham Biomedical Research CentrePfizerCelgeneEli Lilly and CompanyBristol-Myers SquibbChildren's Liver Disease FoundationSanofi
KeywordsObeticholic acidInterim analysisMedicinePlaceboSteatohepatitisInterimInternal medicineFatty liverClinical trialDiseaseAlternative medicinePolitical sciencePathology
Abstract
No abstract in any covered source. Its absence is recorded, not treated as a negative.
No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
metaresearch head score (Codex)0.005
metaresearch head score (Gemma)0.004
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.008
Threshold uncertainty score0.028
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.007 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
Opus teacher head0.034
GPT teacher head0.339
Teacher spread0.305 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".
Quick stats
Citations1,213
Published2019
Admission routes1
Has abstractno