drugset / Trial / NCT04880187

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

NCT04880187 ↗

Phase 2 Unknown 273 enrolled Axcella Health, Inc
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.

Timeline

Start
2021-05-07
Primary completion
2023-09
Completion
2023-10

Drugs

EvaluationDrugModalityDoseRoute
Subject AXA1125 Other / unclassified 22.6 g Oral
Subject AXA1125 Other / unclassified 33.9 g Oral