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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04880187
Study type Interventional
Source Axcella Health, Inc
Contact Margaret Koziel, MD
Phone (857) 320-3200
Email clinicaltrials@axcellahealth.com
Status Recruiting
Phase Phase 2
Start date May 7, 2021
Completion date October 2023

See also
  Status Clinical Trial Phase
Terminated NCT02548351 - Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment Phase 3
Completed NCT04052516 - A Phase 2b Study of Icosabutate in Fatty Liver Disease Phase 2
Completed NCT02098317 - DHA and Vitamin D in Children With Biopsy-proven NAFLD Phase 3
Terminated NCT04065841 - Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis. Phase 2