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

Axcella Health, Inc273 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

273

Conditions

Non Alcoholic Steatohepatitis (NASH)

Interventions

AXA1125DRUG

AXA1125 administered BID with or without food

PlaceboDRUG

Matching Placebo administered BID with or without food

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (75)

Outcomes

Primary Outcomes

Improvement in steatohepatitis

2-point improvement from baseline to Week 48 in the non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) based on a scale from 0-8 with 0 being no NASH and 8 being the highest score

Time frame: Baseline to Week 48

Secondary Outcomes

Resolution of NASH without worsening of fibrosis

The proportion of subjects with resolution of NASH with no worsening of fibrosis defined as a post-treatment ballooning score of 0 and an inflammation score of 0 or 1 on liver biopsy.