Clinical trial design, biomarkers and end points in metabolic and alcohol-related liver disease

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dc.catalogadorgjm
dc.contributor.authorDíaz Piga, Luis Antonio
dc.contributor.authorThiele, Maja
dc.contributor.authorLouvet, Alexandre
dc.contributor.authorLee, Brian P.
dc.contributor.authorAjmera, Veeral
dc.contributor.authorTavaglione, Federica
dc.contributor.authorHsu, Cynthia L.
dc.contributor.authorHuang, Daniel Q.
dc.contributor.authorPose, Elisa
dc.contributor.authorBataller, Ramon
dc.contributor.authorMcClain, Craig
dc.contributor.authorMellinger, Jessica
dc.contributor.authorTincopa, Monica
dc.contributor.authorMitchell, Mack C.
dc.contributor.authorRatziu, Vlad
dc.contributor.authorRinella, Mary E.
dc.contributor.authorSarin, Shiv K.
dc.contributor.authorShah, Vijay H.
dc.contributor.authorSzabo, Gyongyi
dc.contributor.authorWong, Vincent Wai-Sun
dc.contributor.authorBansal, Meena B.
dc.contributor.authorLeggio, Lorenzo
dc.contributor.authorKamath, Patrick S.
dc.contributor.authorKrag, Aleksander
dc.contributor.authorSanyal, Arun J.
dc.contributor.authorArrese, Marco
dc.contributor.authorArab Verdugo, Juan Pablo
dc.contributor.authorAnstee, Quentin M.
dc.contributor.authorMathurin, Philippe
dc.contributor.authorLoomba, Rohit
dc.date.accessioned2025-10-02T16:36:16Z
dc.date.available2025-10-02T16:36:16Z
dc.date.issued2025
dc.description.abstractMetabolic and alcohol-related liver disease (MetALD) is a newly defined entity within the spectrum of steatotic liver disease, characterized by the interplay of cardiometabolic risk factors and alcohol consumption. The evolving epidemiology and complex pathophysiology of MetALD present unique challenges and opportunities for clinical trial design. Inclusion criteria should require simultaneous evidence of metabolic dysfunction (at least two cardiometabolic features) and verified quantifiable alcohol exposure recorded over the preceding 3–6 months. Traditional histological end points are limited by invasiveness, sampling error and interpretative variability. Thus, imaging modalities, serum-based fibrosis biomarkers and quantitative measures of alcohol intake are gaining relevance as non-invasive, reproducible and patient-centric end points aiming to improve trial feasibility. Furthermore, incorporating alcohol biomarkers, stratifying patients by metabolic risk factor burden, and using adaptive designs of trials might enhance the precision and generalizability of MetALD clinical trials. Although uncertainties remain regarding optimal patient selection criteria, event rates and the dynamic interplay between metabolic dysfunction and alcohol intake, ongoing research efforts aim to refine diagnostic criteria, standardize methodologies and validate novel end points. These advances will ultimately accelerate drug development, improve trial efficiency and foster interventions to treat MetALD.
dc.fuente.origenORCID
dc.identifier.urihttps://doi.org/10.1038/s41575-025-01120-5
dc.identifier.urihttps://www.nature.com/articles/s41575-025-01120-5
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/105875
dc.information.autorucEscuela de Medicina; Díaz Piga, Luis Antonio; 0000-0002-8540-4930; 179253
dc.information.autorucEscuela de Medicina; Arrese, Marco; 0000-0002-0499-4191; 76095
dc.information.autorucEscuela de Medicina; Arab Verdugo, Juan Pablo; 0000-0002-8561-396X; 132745
dc.language.isoen
dc.nota.accesocontenido parcial
dc.revistaNature Reviews Gastroenterology & Hepatology
dc.rightsacceso restringido
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.subject.ods03 Good health and well-being
dc.subject.odspa03 Salud y bienestar
dc.titleClinical trial design, biomarkers and end points in metabolic and alcohol-related liver disease
dc.typeartículo
sipa.codpersvinculados179253
sipa.codpersvinculados76095
sipa.codpersvinculados132745
sipa.trazabilidadORCID;2025-09-29
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