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Lookup NU author(s): Professor Arun Sanyal, Professor Quentin AnsteeORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 2025 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. Background: Non-invasive tests (NITs) are not currently approved as biomarkers of treatment response for patients with metabolic dysfunction-associated steatohepatitis (MASH). Aim: This retrospective study explored a panel of NITs for assessing response to semaglutide treatment in patients with MASH randomised in a phase 2b trial (NCT02970942). Methods: The present study was performed using the completer population (268 patients), defined as all patients who were randomised, remained on treatment throughout the trial, and had liver biopsy and NIT results at baseline and week 72. Semaglutide treatment arms were analysed as one semaglutide pooled group. Multiple NITs (alanine transaminase, aspartate transaminase [AST], controlled attenuation parameter, CK18-M30/M65, SomaSignal nonalcoholic steatohepatitis tests, FibroScan-AST, NIS-4, metabolomics advanced steatohepatitis fibrosis score, fibrosis-4 index, liver stiffness measure [LSM], enhanced liver fibrosis [ELF], PRO-C3 and ADAPT) were assessed. Treatment response was evaluated by NITs using either mean changes, responder groups, or risk categories from baseline to week 72. Results: Semaglutide treatment led to significant reductions versus placebo in all NIT scores from as early as 28 weeks. More patients had MASH improvement and fewer had fibrosis progression versus placebo when assessed by a 20% NIT response (0.5 U for ELF); among patients with baseline LSM > 8 kPa and ELF > 9.8 U, a larger proportion achieved LSM < 8 kPa and ELF < 9.8 kPa with semaglutide versus placebo. Conclusion: NITs may be used for assessing a treatment response in patients with MASH. Further studies should confirm the treatment effect of NITs and evaluate the association of NIT changes to outcomes.
Author(s): Nitze LM, Ratziu V, Sanyal AJ, Wong VW-S, Balendran C, Fleckner J, Skalshoi Kjaer M, Krarup N, Anstee QM
Publication type: Article
Publication status: Published
Journal: Alimentary Pharmacology and Therapeutics
Year: 2025
Pages: Epub ahead of print
Online publication date: 23/09/2025
Acceptance date: 07/09/2025
Date deposited: 06/10/2025
ISSN (print): 0269-2813
ISSN (electronic): 1365-2036
Publisher: John Wiley and Sons Inc.
URL: https://doi.org/10.1111/apt.70376
DOI: 10.1111/apt.70376
Data Access Statement: Information about data access request proposals can be found at novonordisk-trials.com.
PubMed id: 40985232
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