Learnings From the Graveyard of Phase 2 and 3 Nonalcoholic Steatohepatitis Trials
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Robust anti-fibrotic effects observed in murine models have frequently failed to translate into significant clinical benefit.
“where robust anti-fibrotic effects observed in murine models (e.g. CCl4, bile duct ligation, or diet-induced MASH models) have frequently failed to translate into significant clinical benefit (193–199).”
From Targeting macrophages in liver fibrosis (2026) · cites this paper as [193]
Cites
Younossi, Z. M., Ratziu, V., Loomba, R., Rinella, M., Anstee, Q. M., Goodman, Z., Bedossa, P., Geier, A., Beckebaum, S., Newsome, P. N., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)33041-7 · Cited by 1,277 · see citing works
Self-citationBrunt, E. M., Kleiner, D. E., Wilson, L. A., Sanyal, A. J., Neuschwander‐Tetri, B. A., & for the Nonalcoholic Steatohepatitis Clinical Research Network (2019) · Hepatology · doi:10.1002/hep.30418 · Cited by 154 · see citing works
Glass, O., Filozof, C., Noureddin, M., Berner-Hansen, M., Schabel, E., Omokaro, S. O., Schattenberg, J. M., Barradas, K., Miller, V., Francque, S., et al. (2020) · Journal of Hepatology · doi:10.1016/j.jhep.2020.04.030 · Cited by 89 · see citing works
Self-citationA critical review of endpoints for non-cirrhotic NASH therapeutic trials
Ratziu, V. (2018) · Journal of Hepatology · doi:10.1016/j.jhep.2017.12.001 · Cited by 74 · see citing works
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Geervliet, E., Karkdijk, E., & Bansal, R. (2024) · Scientific Reports · doi:10.1038/s41598-024-67926-6 · Cited by 15 · see citing works
Targeting macrophages in liver fibrosis
González del Barrio, L., Ipsen, D. H., Pfister, D. R., Hancz, D., & Scott, C. L. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1835489 · Cited by 3 · see citing works
“…and clinical outcomes across the different therapeutic approaches discussed above, where robust anti-fi brotic effects observed in murine models (e.g. CCl 4 , bile duct ligation, or diet-induced MASH models) have frequently failed to translate into signi fi cant clinical bene fi t (193 – 199).”
- Authors
- Francque, S. M., Noureddin, M., & Krag, A.
- Affiliations
- University of Antwerp (BE)
- Houston Methodist (US)
- University of Southern Denmark (DK)
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2024-01
- Volume
- 22
- Issue
- 1
- Pages
- 16-19
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W4385336015
- Cited by
- 9
- References
- 4
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 4
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- nonalcoholic steatohepatitis, clinical trial failure, obeticholic acid, conditional approval, cenicriviroc, liver fibrosis, surrogate endpoints, fibrosis regression, compensated cirrhosis
- MeSH terms
- Humans, Risk Factors, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Non-alcoholic Fatty Liver Disease
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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