Evidence map›Paper›PMID 40985232›Full record

Trial reportAlimentary pharmacology & therapeutics2026

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

Louise Maymann Nitze, Vlad Ratziu, Arun J Sanyal, Vincent Wai-Sun Wong, Clare Balendran, Jan Fleckner, Mette Skalshøi Kjær, Niels Krarup, Quentin M Anstee

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02970942 (This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02970942 phase2completednot on this map

This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2020Enrolled320ConditionsHepatobiliary Disorders, Non-alcoholic SteatohepatitisArmsSemaglutide, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Louise Maymann NitzeNovo Nordisk A/S, Development, Søborg, Denmark.
Vlad RatziuSorbonne Université, Institute for Cardiometabolism and Nutrition, Hôpital Pitié-Salpêtrière, APHP, INSERM UMRS 1138 CRC, Paris, France.ORCID https://orcid.org/0000-0002-3051-0111
Arun J SanyalStravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.ORCID https://orcid.org/0000-0001-8682-5748
Vincent Wai-Sun WongDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.
Clare BalendranNovo Nordisk A/S, Development, Søborg, Denmark.
Jan FlecknerNovo Nordisk A/S, Research & Early Development, Måløv, Denmark.
Mette Skalshøi KjærNovo Nordisk A/S, Development, Søborg, Denmark.
Niels KrarupNovo Nordisk A/S, Development, Søborg, Denmark.
Quentin M AnsteeTranslational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0000-0002-9518-0088

Funding

Novo Nordisk
6 · The paper itself

Abstract

backgroundNon-invasive tests (NITs) are not currently approved as biomarkers of treatment response for patients with metabolic dysfunction-associated steatohepatitis (MASH).

aimThis retrospective study explored a panel of NITs for assessing response to semaglutide treatment in patients with MASH randomised in a phase 2b trial (NCT02970942).

methodsThe 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.

resultsSemaglutide 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.

conclusionNITs 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.

Indexed as

Fatty LiverGlucagon-Like PeptidesHypoglycemic AgentsNon-alcoholic Fatty Liver DiseaseAdultAgedBiomarkersFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeBiomarkersGlucagon-Like PeptidesHypoglycemic Agents

Identifiers

PMID40985232
PMCPMC12807327

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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 OpenQuestion graph.