Evidence map›Paper›PMID 41108609›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2025

A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis.

Javier Armisen, Armando Flor, John Eriksson, Karin Nelander, Chandrali S Bhattacharya, Mikael Sunnåker, Debra Carter, Monika Trebski, Emma Gårdmark, Malin Aurell and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05638737 (A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05638737 phase2completednot on this map

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 (Mitiperstat) in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis

TypeinterventionalSponsorAstraZenecaRan2022 to 2024Enrolled112ConditionsNon-Cirrhotic Non-alcoholic Steatohepatitis With FibrosisArmsAZD4831, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Trial
  2. Article
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

14 authors.

Javier ArmisenResearch and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Armando FlorResearch and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.ORCID 0009-0007-3919-4235
John ErikssonCardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Karin NelanderCardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Chandrali S BhattacharyaClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Mikael SunnåkerClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0009-0003-5881-4998
Debra CarterGlobal Patient Safety, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Monika TrebskiGlobal Patient Safety, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Emma GårdmarkClinical Operations, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Malin AurellClinical Operations, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Carl WhatlingTranslational Science and Experimental Medicine, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Benjamin ChallisTranslational Science and Experimental Medicine, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Umberto Vespasiani-GentilucciResearch Unit of Clinical Medicine and Hepatology, Department of Medicine and Surgery, Università Campus bio-Medico di Roma, Rome, Italy.
COSMOS Investigators

Funding

AstraZeneca
6 · The paper itself

Abstract

BACKGROUND AND

aimsNeutrophil myeloperoxidase is involved in different inflammatory diseases, including metabolic dysfunction-associated steatohepatitis (MASH). Mitiperstat is a highly potent myeloperoxidase inhibitor. This phase 2a clinical trial evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of mitiperstat in patients with non-cirrhotic MASH.

methodsThe study enrolled 112 adult participants with histological MASH F1-3 fibrosis and increased alanine aminotransferase (ALT) levels. Participants were randomised 1:1 to once-daily mitiperstat 5 mg or placebo. Primary and secondary endpoints were absolute and placebo-adjusted changes from baseline to week 12 in ALT and N-terminal type-III collagen propeptide (Pro-C3) levels. Exploratory endpoints included other MASH-related biomarkers.

resultsAt week 12, there were no significant changes versus placebo for ALT (+7.5%, p = 0.893) and Pro-C3 (-0.9%, p = 0.396), or any other MASH-related biomarkers. Mitiperstat was safe and well tolerated.

conclusionThis study does not provide proof of concept that mitiperstat 5 mg exerts an anti-inflammatory/anti-fibrotic effect in MASH.

trial registrationClincalTrials.gov identifier: NCT05638737.

Indexed as

Fatty LiverNon-alcoholic Fatty Liver DiseasePeroxidaseAdultAgedAlanine TransaminaseBiomarkersDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAlanine TransaminaseBiomarkersPeroxidasemetabolic dysfunction‐associated steatohepatitis (MASH)metabolic dysfunction‐associated steatotic liver disease (MASLD)mitiperstatmyeloperoxidase inhibitor

Identifiers

PMID41108609
PMCPMC12535277

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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.