Status:
UNKNOWN
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Lead Sponsor:
Axcella Health, Inc
Conditions:
Non Alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 n...
Eligibility Criteria
Inclusion
- 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
- History or presence of liver disease (other than NAFLD or NASH)
- History or presence of cirrhosis and/or history or presence of hepatic decompensation
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT04880187
Start Date
May 7 2021
End Date
October 1 2023
Last Update
September 8 2022
Active Locations (75)
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1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
3
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
4
San Fernando Valley Health Institute
Canoga Park, California, United States, 91304