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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    273
  • sponsor
    Axcella Health, Inc
Updated on 7 October 2022

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.

Details
Condition Non Alcoholic Steatohepatitis (NASH)
Treatment Placebo, AXA1125
Clinical Study IdentifierNCT04880187
SponsorAxcella Health, Inc
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing to participate in the study and provide written informed consent
Male and female adults aged > 18 years
Must have NASH and fibrosis on a liver biopsy sample
If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening
Subjects may have a diagnosis of T2DM

Exclusion Criteria

History or presence of liver disease (other than NAFLD or NASH)
History or presence of cirrhosis and/or history or presence of hepatic decompensation
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