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

Phase 2
Conditions
Non Alcoholic Steatohepatitis (NASH)
Interventions
Drug: Placebo
Registration Number
NCT04880187
Lead Sponsor
Axcella Health, Inc
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
273
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AXA1125 22.6gAXA112522.6 g AXA1125 administered orally BID with or without food
AXA1125 33.9gAXA112533.9 g AXA1125 administered orally BID with or without food
PlaceboPlaceboMatching Placebo administered orally BID with or without food
Primary Outcome Measures
NameTimeMethod
Improvement in steatohepatitisBaseline to Week 48

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

Secondary Outcome Measures
NameTimeMethod
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)Baseline to week 48
Resolution of NASH without worsening of fibrosisBaseline to week 48

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.

Improvement of fibrosis by one stage without worsening of NASHBaseline to week 48

The proportion of subjects who have at least a 1-stage improvement in fibrosis and no worsening of NASH based on liver biopsy 0 being no fibrosis and 4 being the worse.

Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)Baseline to week 48
Change from baseline in hepatic fat as measured by MRIBaseline to week 48
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)Baseline to week 48

Trial Locations

Locations (69)

Cullman Clinical Trials

🇺🇸

Cullman, Alabama, United States

Adobe Clinical Research, LLC

🇺🇸

Tucson, Arizona, United States

Del Sol Research Management, LLC

🇺🇸

Tucson, Arizona, United States

San Fernando Valley Health Institute

🇺🇸

Canoga Park, California, United States

National Research Institute

🇺🇸

Los Angeles, California, United States

OM Research LLC

🇺🇸

Lancaster, California, United States

Inland Empire Liver Foundation

🇺🇸

Rialto, California, United States

Precision Research Institute, LLC

🇺🇸

San Diego, California, United States

Excel Medical Clinical Trials, LLC

🇺🇸

Boca Raton, Florida, United States

Synergy Healthcare

🇺🇸

Bradenton, Florida, United States

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Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States

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