Exploration of Multiple Non‐Invasive Tests for Assessing Response to Treatment in a Semaglutide Phase 2b Trial in Patients with MASH

Sep 23, 2025Alimentary pharmacology & therapeutics

Non-Invasive Tests to Measure Treatment Response in a Semaglutide Trial for Fatty Liver Disease

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Abstract

Semaglutide treatment resulted in significant reductions in all non-invasive test scores compared to placebo by 28 weeks.

A total of 268 patients were analyzed, all of whom completed the trial with liver biopsy and non-invasive test results at baseline and week 72.
Patients receiving semaglutide showed improvements in metabolic dysfunction-associated steatohepatitis (MASH) status and less fibrosis progression compared to those on placebo.
A 20% response in non-invasive tests was observed in more patients treated with semaglutide, indicating potential effectiveness.
Among patients with higher baseline liver stiffness and enhanced liver fibrosis scores, a greater proportion achieved lower scores with semaglutide than with placebo.
Non-invasive tests may serve as biomarkers to assess treatment response in MASH, although further studies are needed to confirm these findings.

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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.

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Exploration of Multiple Non‐Invasive Tests for Assessing Response to Treatment in a Semaglutide Phase 2b Trial in Patients with MASH

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