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

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18 years and over
This study is NOT accepting healthy volunteers
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

Drug: AXA1125, Drug: Placebo

Non Alcoholic Steatohepatitis (NASH)

Steatosis, Lobular inflammation, Ballooning, Liver biopsy, Liver fat, Liver stiffness, NASH, Aminio Acids, Fibrosis

Margaret Koziel, MD - clinicaltrials@axcellahealth.com
Siddiqui, Mohammad, S
Phase 2
HM20022234
NCT04880187
See this study on ClinicalTrials.gov

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