A Study in Participants With Non-cirrhotic NASH With Fibrosis

Phase 2 Completed 112 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and a 4-week safety follow-up period Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.

Timeline

Start: 2022-10-26
Primary completion: 2024-04-04
Completion: 2024-04-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Mitiperstat (5mg) vs Placebo; p = 0.893; %-change in relative to base vs placebo 7.5 (95% CI -4.1 to 20.5) NCT05638737 ↗

paper At week 12, there were no significant changes versus placebo for ALT (+7.5%, p = 0.893) PMID 41108609 ↗

Publications

Armisen J, Flor A, Eriksson J, Nelander K, Bhattacharya CS, Sunnaker M, Carter D, Trebski M, Gardmark E, Aurell M, Whatling C, Challis B, Vespasiani-Gentilucci U; COSMOS Investigators. A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis. Liver Int. 2025 Nov;45(11):e70406. doi: 10.1111/liv.70406.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mitiperstat	Small molecule	5 mg	—