UnknownPhase 2

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

United States273 participantsStarted 2021-05-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Improvement in steatohepatitis

Timeframe: Baseline to Week 48

Trial details

NCT IDNCT04880187

SponsorAxcella Health, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09

Contact for this trial

Margaret Koziel, MD

(857) 320-3200 clinicaltrials@axcellahealth.com

View on ClinicalTrials.gov More Non Alcoholic Steatohepatitis (NASH) trials