Evidence map›Paper›PMID 34670042›Full record

Trial reportThe New England journal of medicine2021

A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH.

Sven M Francque, Pierre Bedossa, Vlad Ratziu, Quentin M Anstee, Elisabetta Bugianesi, Arun J Sanyal, Rohit Loomba, Stephen A Harrison, Rozalina Balabanska, Lyudmila Mateva and 18 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03008070 (A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis), which is not on this map. Cited by 403 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
403citing papers in PubMed, 6 pooled it
65.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03008070 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

TypeinterventionalSponsorInventiva PharmaRan2017 to 2020Enrolled247ConditionsNon-Alcoholic Steatohepatitis (NASH)ArmsIVA337, Placebo
3 · Its place in the literature

Who cites it

403 citing papers in PubMed, 6 syntheses or guidelines pooled it, 673 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Trial
  8. Review
  9. Review
  10. One drug, five targets.Cell research · 2026
    Article
  11. Review
  12. Article
  13. Subcutaneous Fat Density Is an Independent Predictor of Adverse Outcomes and Shows Early Improvement After Liver Transplantation.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  14. Review
  15. Review
  16. Article
  17. Review
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  19. Review
  20. MAFLD/MASLD: Past, Present, and Future.Journal of gastroenterology and hepatology · 2026
    Review

343 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 1 institution in 9 countries.

Sven M FrancqueFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).ORCID 0000-0002-7527-4714
Pierre BedossaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Vlad RatziuFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Quentin M AnsteeFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Elisabetta BugianesiFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Arun J SanyalFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Rohit LoombaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Stephen A HarrisonFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Rozalina BalabanskaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Lyudmila MatevaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Nicolas LanthierFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).ORCID 0000-0002-7651-9314
Naim AlkhouriFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Christophe MorenoFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Jörn M SchattenbergFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).ORCID 0000-0002-4224-4703
Diana Stefanova-PetrovaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Luisa VonghiaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Régine RouzierFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Maeva GuillaumeFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Alexander HodgeFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Manuel Romero-GómezFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Philippe Huot-MarchandFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Martine BaudinFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Marie-Paule RichardFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Jean-Louis AbitbolFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Pierre BroquaFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Jean-Louis JunienFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
Manal F AbdelmalekFrom Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital "St. Ivan Rilski," Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).
NATIVE Study Group
Cliniques Universitaires Saint-Luc · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManagement of nonalcoholic steatohepatitis (NASH) is an unmet clinical need. Lanifibranor is a pan-PPAR (peroxisome proliferator-activated receptor) agonist that modulates key metabolic, inflammatory, and fibrogenic pathways in the pathogenesis of NASH.

methodsIn this phase 2b, double-blind, randomized, placebo-controlled trial, patients with noncirrhotic, highly active NASH were randomly assigned in a 1:1:1 ratio to receive 1200 mg or 800 mg of lanifibranor or placebo once daily for 24 weeks. The primary end point was a decrease of at least 2 points in the SAF-A score (the activity part of the Steatosis, Activity, Fibrosis [SAF] scoring system that incorporates scores for ballooning and inflammation) without worsening of fibrosis; SAF-A scores range from 0 to 4, with higher scores indicating more-severe disease activity. Secondary end points included resolution of NASH and regression of fibrosis.

resultsA total of 247 patients underwent randomization, of whom 103 (42%) had type 2 diabetes mellitus and 188 (76%) had significant (moderate) or advanced fibrosis. The percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly higher among those who received the 1200-mg dose, but not among those who received the 800-mg dose, of lanifibranor than among those who received placebo (1200-mg dose vs. placebo, 55% vs. 33%, P = 0.007; 800-mg dose vs. placebo, 48% vs. 33%, P = 0.07). The results favored both the 1200-mg and 800-mg doses of lanifibranor over placebo for resolution of NASH without worsening of fibrosis (49% and 39%, respectively, vs. 22%), improvement in fibrosis stage of at least 1 without worsening of NASH (48% and 34%, respectively, vs. 29%), and resolution of NASH plus improvement in fibrosis stage of at least 1 (35% and 25%, respectively, vs. 9%). Liver enzyme levels decreased and the levels of the majority of lipid, inflammatory, and fibrosis biomarkers improved in the lanifibranor groups. The dropout rate for adverse events was less than 5% and was similar across the trial groups. Diarrhea, nausea, peripheral edema, anemia, and weight gain occurred more frequently with lanifibranor than with placebo.

conclusionsIn this phase 2b trial involving patients with active NASH, the percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly higher with the 1200-mg dose of lanifibranor than with placebo. These findings support further assessment of lanifibranor in phase 3 trials. (Funded by Inventiva Pharma; NATIVE ClinicalTrials.gov number, NCT03008070.).

Indexed as

BenzothiazolesBody Mass IndexDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLiver CirrhosisMaleMiddle AgedNon-alcoholic Fatty Liver DiseasePeroxisome Proliferator-Activated ReceptorsSeverity of Illness IndexSulfonamidesBenzothiazoleslanifibranorPeroxisome Proliferator-Activated ReceptorsSulfonamides

Identifiers

PMID34670042
OpenAlexW3207086349

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.