Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Non Alcoholic Steatohepatitis (NASH)
In brief
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.
Key facts
- Study ID
- NCT04880187
- Run by
- Axcella Health, Inc
- People needed
- 273
- Starts
- 2021-05-07
- Expected to finish
- 2023-10-01
- Last updated by the study team
- 2022-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History or presence of liver disease (other than NAFLD or NASH)
- History or presence of cirrhosis and/or history or presence of hepatic decompensation
Where it is running
- Adobe Clinical Research, LLC — Tucson, Arizona, United States (enrolling)
- Del Sol Research Management, LLC — Tucson, Arizona, United States (enrolling)
- San Fernando Valley Health Institute — Canoga Park, California, United States (enrolling)
- National Research Institute — Gardena, California, United States (enrolling)
- National Research Institute — Huntington Park, California, United States (enrolling)
- OM Research LLC — Lancaster, California, United States (enrolling)
- National Research Institute — Los Angeles, California, United States (enrolling)
- Inland Empire Liver Foundation — Rialto, California, United States (enrolling)
- Precision Research Institute, LLC — San Diego, California, United States (enrolling)
- Excel Medical Clinical Trials, LLC — Boca Raton, Florida, United States (enrolling)
- Synergy Healthcare — Bradenton, Florida, United States (enrolling)
- Tampa Bay Medical Research , Inc. — Clearwater, Florida, United States (enrolling)
- Evolution Clinical Trials, Inc. — Hialeah Gardens, Florida, United States (enrolling)
- Westside Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
- ENCORE Borland Groover Clinical Research — Jacksonville, Florida, United States (enrolling)
- ClinCloud LLC — Maitland, Florida, United States (enrolling)
- Clinical Pharmacology of Miami, LLC — Miami, Florida, United States (enrolling)
- La Salud Research — Miami, Florida, United States (enrolling)
- Genoma Research Group, Inc — Miami, Florida, United States (enrolling)
- Panax Clinical Research — Miami Lakes, Florida, United States (enrolling)
- Sensible Healthcare, LLC — Ocoee, Florida, United States (enrolling)
- Theia Clinical Research, LLC — Pinellas Park, Florida, United States (enrolling)
- Progressive Medical Research — Port Orange, Florida, United States (enrolling)
- ClinCloud, LLC — Viera, Florida, United States (enrolling)
- Cullman Clinical Trials — Cullman, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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