ReviewHepatology international2026
Noninvasive surrogate endpoints in MASH trials: current perspectives and challenges.
Review in Hepatology international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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.
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Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
backgroundMetabolic dysfunction-associated steatohepatitis (MASH) is a leading cause of cirrhosis and liver-related morbidity. Current regulatory pathways rely on histology and long-term clinical outcomes, but repeated liver biopsy is noninvasive and poorly reproducible; regulators have signaled interest in noninvasive tests (NITs) as surrogate endpoints.
methodsThis review synthesizes contemporary regulatory perspectives, the evidentiary framework for biomarker qualification, and the published performance of leading noninvasive tests (vibration-controlled transient elastography [VCTE], magnetic resonance elastography [MRE], and the enhanced liver fibrosis [ELF] test). We summarize diagnostic, prognostic, monitoring and response assessment data from cohort studies, meta-analyses and trial datasets, and outline the analytical and clinical validation steps required for reasonably likely surrogate endpoint (RLSE) qualification.
resultsEvidence shows that baseline values and longitudinal changes in liver stiffness measurement (LSM by VCTE and MRE) and ELF correlate with histological stage and predict liver-related events. VCTE offers broad accessibility and a mature outcome linkage; MRE provides superior accuracy and repeatability; ELF supplies a scalable prognostic blood signal. However, variability in measurement, limited trial-level surrogacy data, and low-event rates in pre-cirrhotic cohorts constrain definitive qualification. Composite or tiered strategies and prospective trial datasets linking on-treatment NIT changes to major adverse liver outcomes are needed.
conclusionsNITs show promise as surrogate endpoints for MASH trials, but full qualification as RLSE requires standardized assays, robust prospective evidence that treatment‑induced biomarker changes predict hard clinical outcomes, and close collaboration among academia, industry, and regulators.
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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 Socratic graph.