Liver international : official journal of the International Association for the Study of the Liver · 2025
A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Armisen Javier, Flor Armando, Eriksson John, Nelander Karin, Bhattacharya Chandrali S, Sunnåker Mikael, Carter Debra, Trebski Monika, Gårdmark Emma, Aurell Malin, Whatling Carl, Challis Benjamin, Vespasiani-Gentilucci Umberto, COSMOS Investigators
Аннотация
BACKGROUND AND AIMS: Neutrophil 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.
METHODS: The 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.
RESULTS: At 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.
CONCLUSION: This study does not provide proof of concept that mitiperstat 5 mg exerts an anti-inflammatory/anti-fibrotic effect in MASH.
TRIAL REGISTRATION: ClincalTrials.gov identifier: NCT05638737.
METHODS: The 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.
RESULTS: At 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.
CONCLUSION: This study does not provide proof of concept that mitiperstat 5 mg exerts an anti-inflammatory/anti-fibrotic effect in MASH.
TRIAL REGISTRATION: ClincalTrials.gov identifier: NCT05638737.