Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
- 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
- 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
- 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
Group Intervention Description AXA1125 22.6g AXA1125 22.6 g AXA1125 administered orally BID with or without food AXA1125 33.9g AXA1125 33.9 g AXA1125 administered orally BID with or without food Placebo Placebo Matching Placebo administered orally BID with or without food
- Primary Outcome Measures
Name Time Method Improvement in steatohepatitis Baseline 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
Name Time Method Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs) Baseline to week 48 Resolution of NASH without worsening of fibrosis Baseline 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 NASH Baseline 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 MRI Baseline 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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