Overview

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

Status:
Recruiting

Trial end date:
2023-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Axcella Health, Inc

Criteria

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