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Design and rationale for a global novel non-invasive screening observational study using genetics and non-invasive methodologies to identify at-risk MASLD participants: The ALIGN study
Indexado
WoS WOS:001409707600001
Scopus SCOPUS_ID:85215827881
DOI 10.1016/J.CONCTC.2025.101437
Año 2025
Tipo artículo de investigación

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras


Abstract



Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common chronic liver disease that is heterogenous in nature with various drivers and modifiers such as metabolic dysfunction and genetic factors. MASLD and the progressive subtype, metabolic dysfunction-associated steatohepatitis (MASH) represent the most rapidly increasing cause of liver-related mortality. There are limited treatment options for patients living with MASLD and MASH, various treatments with an array of different targets are under investigation and one therapeutic has been approved since the initiation of this study. Clinical trials investigating treatments for MASLD and MASH are associated with a high screen failure rate, driven largely by the regulatory required histological inclusion criteria for clinical trial eligibility. Other available clinically utilized biomarkers, typically referred to as non-invasive tests (NITs), can assess both the presence of steatosis and the severity of liver fibrosis in patients with MASLD and MASH in the clinic but are not yet approved over histological changes as endpoints for pivotal trials. However, the use of NITs have been demonstrated to increase the likelihood of meeting clinical trial entry criteria. All-Liver Interventional Global Network (ALIGN) is the first described multi-centre global observational screening study aimed at identifying individuals with a high likelihood of MASLD/MASH interested in participating in therapeutic clinical trials using non-invasive methodologies and genetic testing. This study represents a valuable prototype for industry and academic groups looking to evaluate large populations for MASH eligibility and interest in clinical trial participation.

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Disciplinas de Investigación



WOS
Medicine, Research & Experimental
Scopus
Medicine (All)
Pharmacology
SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional



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Autores - Afiliación



Ord. Autor Género Institución - País
1 Daniels, Samuel J. - AstraZeneca - Reino Unido
2 Nelander, Karin - AstraZeneca - Suecia
AstraZeneca Sweden - Suecia
3 Eriksson, John - AstraZeneca - Suecia
AstraZeneca Sweden - Suecia
4 Jermutus, Lutz - AstraZeneca - Reino Unido
5 Saillard, Jelena - AstraZeneca - Estados Unidos
AstraZeneca - Reino Unido
6 Oyesola, Stephanie - AstraZeneca - Reino Unido
7 Tavaglione, Federica - Fdn Policlin Univ Campus Biomed - Italia
Univ Campus Biomed Roma - Italia
Fondazione Policlinico Universitario Campus Bio-Medico - Italia
8 Arrese, Marco - Pontificia Universidad Católica de Chile - Chile
Escuela de Medicina - Chile
9 de Guevara, Alma Laura Ladron - Ctr Invest & Gastroenterol SC - México
Centro de Investigacion y Gastroenterologia S. C. - México
9 Ladrón de Guevara, Alma Laura - Centro de Investigacion y Gastroenterologia S. C. - México
10 Vespasiani-Gentilucci, Umberto - Fdn Policlin Univ Campus Biomed - Italia
Univ Campus Biomed Roma - Italia
Fondazione Policlinico Universitario Campus Bio-Medico - Italia
11 Alkhouri, Naim - Arizona Liver Hlth - Estados Unidos
Arizona Liver Health - Estados Unidos
12 Blau, Jenny E. - AstraZeneca - Estados Unidos
AstraZeneca - Reino Unido

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Financiamiento



Fuente
AstraZeneca

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Agradecimientos



Agradecimiento
The ALIGN study was funded by AstraZeneca.
The ALIGN study was funded by AstraZeneca.

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