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Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)

NCT04880187•Axcella Health, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (75)

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

Gardena, California, United States

National Research Institute

Huntington Park, California, United States

OM Research LLC

Lancaster, California, United States

National Research Institute

Los Angeles, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Precision Research Institute, LLC

San Diego, California, United States

Key Dates

Start Date

May 7, 2021

Primary Completion Date

September 1, 2023

Completion Date

October 1, 2023

Last Updated

September 8, 2022

Enrollment

273

ESTIMATED participants

Conditions

Non Alcoholic Steatohepatitis (NASH)

Interventions

AXA1125

DRUG

Placebo

DRUG

Contacts

Margaret Koziel, MD

CONTACT

(857) 320-3200 clinicaltrials@axcellahealth.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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