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

Last updated: September 7, 2022
Sponsor: Axcella Health, Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Liver Disease

Treatment

N/A

Clinical Study ID

NCT04880187
AXA1125-101
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 toScreening;
  • Subjects may have a diagnosis of T2DM

Exclusion

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

Study Design

Total Participants: 273
Study Start date:
May 07, 2021
Estimated Completion Date:
October 31, 2023

Connect with a study center

  • Flinders Medical Centre

    Bedford Park,
    Australia

    Active - Recruiting

  • Royal Brisbane and Women's Hospital

    Brisbane,
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton,
    Australia

    Active - Recruiting

  • Concord Repatriation General Hospital

    Concord,
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch,
    Australia

    Active - Recruiting

  • University of Calgary Liver Unit

    Calgary, Alberta
    Canada

    Active - Recruiting

  • LMC Diabetes & Endocrinology Ltd

    London, Ontario
    Canada

    Active - Recruiting

  • Toronto Liver Centre

    Toronto, Ontario M6H 3M1
    Canada

    Active - Recruiting

  • Nova Scotia Health Authority

    Halifax,
    Canada

    Active - Recruiting

  • CHU Grenoble-Alpes - Hopital Michallon

    La Tronche,
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse - HCL

    Lyon,
    France

    Active - Recruiting

  • CHU de Montpellier - Hopital Saint Eloi

    Montpellier,
    France

    Active - Recruiting

  • AP-HP Hopital Saint Antoine

    Paris,
    France

    Active - Recruiting

  • CHU Bordeaux - Hopital Haut-Leveque

    Pessac,
    France

    Active - Recruiting

  • AP-HP Hopital Paul Brousse

    Villejuif,
    France

    Active - Recruiting

  • ID Clinic

    Myslowice, CET
    Poland

    Active - Recruiting

  • Fundacion de Investigacion (FDI)

    San Juan,
    Puerto Rico

    Active - Recruiting

  • King's College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Cullman Clinical Trials

    Cullman, Alabama 35055
    United States

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  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

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  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

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  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

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  • National Research Institute

    Gardena, California 90247
    United States

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  • National Research Institute

    Huntington Park, California 90255
    United States

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  • OM Research LLC

    Lancaster, California 93534
    United States

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  • National Research Institute

    Los Angeles, California 90057
    United States

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  • Inland Empire Liver Foundation

    Rialto, California 92377
    United States

    Active - Recruiting

  • Precision Research Institute, LLC

    San Diego, California 92114
    United States

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    Boca Raton, Florida 33434
    United States

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    Bradenton, Florida 34208
    United States

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    Clearwater, Florida 33761
    United States

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    Hialeah Gardens, Florida 33016
    United States

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    Jacksonville, Florida 32256
    United States

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    Jacksonville, Florida 32205
    United States

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  • ClinCloud LLC

    Maitland, Florida 32751
    United States

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  • Clinical Pharmacology of Miami, LLC

    Miami, Florida 33014-3616
    United States

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  • Genoma Research Group, Inc

    Miami, Florida 33173
    United States

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  • La Salud Research

    Miami, Florida 33155
    United States

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  • Panax Clinical Research

    Miami Lakes, Florida 33014
    United States

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  • Sensible Healthcare, LLC

    Ocoee, Florida 34761
    United States

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  • Theia Clinical Research, LLC

    Pinellas Park, Florida 33709
    United States

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  • Progressive Medical Research

    Port Orange, Florida 32124
    United States

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  • ClinCloud, LLC

    Viera, Florida 32940
    United States

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  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida 33401
    United States

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  • Conquest Research

    Winter Park, Florida 32789
    United States

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  • ASHA Clinical Research

    Hammond, Indiana 46324
    United States

    Active - Recruiting

  • Indiana University (IU) School of Medicine

    Indianapolis, Indiana 46202
    United States

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  • Delta Research Partners

    Bastrop, Louisiana 71201
    United States

    Active - Recruiting

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

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  • Tandem Clinical Research GI

    Metairie, Louisiana 70006
    United States

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  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • The National Diabetes & Obesity Research Institute

    Biloxi, Mississippi 39532
    United States

    Active - Recruiting

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Sierra Clinical Research

    Las Vegas, Nevada 89106
    United States

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  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Tandem Clinical Research GI

    New York, New York 10033
    United States

    Active - Recruiting

  • Lucas Research - Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Rapid City Medical Center

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • ClinSearch LLC

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Texas Clinical Research Institute

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • American Research Corporation

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Pinnacle Clinical Research

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Pioneer Research Solutions Inc.

    Houston, Texas 77099
    United States

    Active - Recruiting

  • R & H Clinical Research

    Katy, Texas 77494
    United States

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  • EPIC Medical Research

    Red Oak, Texas 75154
    United States

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    San Antonio, Texas 78215
    United States

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    San Antonio, Texas 78229
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    San Antonio, Texas 78229
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    Stafford, Texas 77477
    United States

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  • Simcare Medical Research, LLC

    Sugar Land, Texas 77478
    United States

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  • Impact Clinical Research

    Waco, Texas 76710
    United States

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  • EPIC Medical Research

    Murray, Utah 75154
    United States

    Site Not Available

  • Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog

    Riverton, Utah 84065
    United States

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  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

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  • Virginia Commonwealth University Medical College of Virginia

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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