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

ID#: NCT04880187

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: May 07, 2021

End Date: October 01, 2023

Contact Information:
Margaret Koziel, MD
(857) 320-3200
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.

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