Research and clinical trial design in patients with metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD): a narrative review

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dc.catalogadorgjm
dc.contributor.authorAcuña Valenzuela, Pedro Pablo
dc.contributor.authorAlbhaisi, Omar
dc.contributor.authorIdalsoaga Ferrer, Francisco Javier
dc.contributor.authorAlkhouri, Naim
dc.contributor.authorNoureddin, Mazen
dc.contributor.authorDiaz Piga, Luis Antonio
dc.contributor.authorArab Verdugo, Juan Pablo
dc.date.accessioned2025-11-27T13:50:11Z
dc.date.available2025-11-27T13:50:11Z
dc.date.issued2025
dc.description.abstractThis narrative review examines current trial design strategies and highlights the limitations of traditional models in capturing the heterogeneity and dynamic nature of metabolic dysfunction and alcohol-associated liver disease (MetALD). MetALD represents an increasingly prevalent and clinically distinct phenotype that reflects the convergence of metabolic risk factors and alcohol-related liver injury. Designing effective clinical and translational research in MetALD presents unique challenges as its burden continues to rise. Novel frameworks, such as adaptive and enrichment designs, offer improved pathways for patient stratification and intervention testing. The integration of molecular and translational biomarkers to inform diagnosis, prognosis, and therapeutic responsiveness is central to this evolution. This review also addresses critical methodological issues, including the need for harmonized definitions, careful endpoint selection, and real-world applicability of findings. Emerging therapies targeting steatosis, inflammation, fibrosis, gut-liver axis dysfunction, and metabolic pathways are now entering clinical development and require trial designs tailored to the multifaceted biology of MetALD. In this context, the article also discusses the importance of early-phase proof-of-concept studies and innovative approaches for combination therapies. Ethical and operational considerations, such as alcohol use thresholds, stigma, and disparities in access to care, further influence trial feasibility and generalizability. Finally, multidisciplinary collaboration across hepatology, addiction medicine, endocrinology, and trial methodology is essential to advance this field.
dc.fechaingreso.objetodigital2025-11-27
dc.format.extent17 páginas
dc.fuente.origenORCID
dc.identifier.doi10.20517/mtod.2025.61
dc.identifier.urihttps://doi.org/10.20517/mtod.2025.61
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/107150
dc.information.autorucEscuela de Medicina; Acuña Valenzuela, Pedro Pablo; S/I; 1211228
dc.information.autorucEscuela de Medicina; Idalsoaga Ferrer, Francisco Javier; S/I; 1017394
dc.information.autorucEscuela de Medicina; Diaz Piga, Luis Antonio; 0000-0002-8540-4930; 179253
dc.information.autorucEscuela de Medicina; Arab Verdugo, Juan Pablo; 0000-0002-8561-396X; 132745
dc.issue.numero52
dc.language.isoen
dc.nota.accesocontenido completo
dc.revistaMetabolism and Target Organ Damage
dc.rightsacceso abierto
dc.rights.licenseCC BY 4.0 Attribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectMASLD
dc.subjectNAFLD
dc.subjectNon-alcoholic fatty liver disease
dc.subjectMetabolic dysfunction-associated steatotic liver disease
dc.subjectAlcohol-related liver disease
dc.subjectAlcoholic cirrhosis
dc.subjectCirrhosis
dc.subject.ddc610
dc.subject.ods03 Good health and well-being
dc.subject.odspa03 Salud y bienestar
dc.titleResearch and clinical trial design in patients with metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD): a narrative review
dc.typeartículo
dc.volumen5
sipa.codpersvinculados1211228
sipa.codpersvinculados1017394
sipa.codpersvinculados179253
sipa.codpersvinculados132745
sipa.trazabilidadORCID;2025-11-24
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