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

September 7, 2022 updated by: Axcella Health, Inc

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

273

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Bedford Park, Australia
        • Recruiting
        • Flinders Medical Centre
      • Brisbane, Australia
        • Recruiting
        • Royal Brisbane and Women'S Hospital
      • Clayton, Australia
        • Recruiting
        • Monash Medical Centre
      • Concord, Australia
        • Recruiting
        • Concord Repatriation General Hospital
      • Murdoch, Australia
        • Recruiting
        • Fiona Stanley Hospital
  • Canada
      • Halifax, Canada
        • Recruiting
        • Nova Scotia Health Authority
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • University of Calgary Liver Unit
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • LMC Diabetes & Endocrinology Ltd
      • Toronto, Ontario, Canada, M6H 3M1
        • Recruiting
        • Toronto Liver Centre
  • France
      • La Tronche, France
        • Recruiting
        • CHU Grenoble-Alpes - Hopital Michallon
      • Lyon, France
        • Recruiting
        • Hôpital de la Croix Rousse - HCL
      • Montpellier, France
        • Recruiting
        • CHU DE MONTPELLIER - Hopital Saint Eloi
      • Paris, France
        • Recruiting
        • AP-HP Hopital Saint Antoine
      • Pessac, France
        • Recruiting
        • CHU Bordeaux - Hopital Haut-Leveque
      • Villejuif, France
        • Recruiting
        • AP-HP Hopital Paul Brousse
  • Poland
    • CET
      • Myslowice, CET, Poland
        • Recruiting
        • ID Clinic
  • Puerto Rico
      • San Juan, Puerto Rico
        • Recruiting
        • Fundacion de Investigacion (FDI)
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • King's College Hospital
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Recruiting
        • Cullman Clinical Trials
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Adobe Clinical Research, LLC
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management, LLC
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • San Fernando Valley Health Institute
      • Gardena, California, United States, 90247
        • Recruiting
        • National Research Institute
      • Huntington Park, California, United States, 90255
        • Recruiting
        • National Research Institute
      • Lancaster, California, United States, 93534
        • Recruiting
        • Om Research LLC
      • Los Angeles, California, United States, 90057
        • Recruiting
        • National Research Institute
      • Rialto, California, United States, 92377
        • Recruiting
        • Inland Empire Liver Foundation
      • San Diego, California, United States, 92114
        • Recruiting
        • Precision Research Institute, LLC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Excel Medical Clinical Trials, LLC
      • Bradenton, Florida, United States, 34208
        • Recruiting
        • Synergy Healthcare
      • Clearwater, Florida, United States, 33761
        • Recruiting
        • Tampa Bay Medical Research , Inc.
      • Hialeah Gardens, Florida, United States, 33016
        • Recruiting
        • Evolution Clinical Trials, Inc.
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • ENCORE Borland Groover Clinical Research
      • Jacksonville, Florida, United States, 32205
        • Recruiting
        • Westside Center for Clinical Research
      • Maitland, Florida, United States, 32751
        • Recruiting
        • ClinCloud LLC
      • Miami, Florida, United States, 33014-3616
        • Recruiting
        • Clinical Pharmacology of Miami, LLC
      • Miami, Florida, United States, 33155
        • Recruiting
        • La Salud Research
      • Miami, Florida, United States, 33173
        • Recruiting
        • Genoma Research Group, Inc
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Panax Clinical Research
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Sensible Healthcare, LLC
      • Pinellas Park, Florida, United States, 33709
        • Recruiting
        • Theia Clinical Research, LLC
      • Port Orange, Florida, United States, 32124
        • Recruiting
        • Progressive Medical Research
      • Viera, Florida, United States, 32940
        • Recruiting
        • ClinCloud, LLC
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Metabolic Research Institute, Inc.
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
    • Indiana
      • Hammond, Indiana, United States, 46324
        • Recruiting
        • ASHA Clinical Research
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University (IU) School of Medicine
    • Louisiana
      • Bastrop, Louisiana, United States, 71201
        • Recruiting
        • Delta Research Partners
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Tandem Clinical Research GI
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Louisiana Research Center, LLC
    • Mississippi
      • Biloxi, Mississippi, United States, 39532
        • Recruiting
        • The National Diabetes & Obesity Research Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Sierra Clinical Research
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Jubilee Clinical Research, Inc.
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10033
        • Recruiting
        • Tandem Clinical Research GI
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research - Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Consultants for Clinical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Rapid City Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • ClinSearch LLC
    • Texas
      • Arlington, Texas, United States, 76012
        • Recruiting
        • Texas Clinical Research Institute
      • Austin, Texas, United States, 78757
        • Recruiting
        • Pinnacle Clinical Research
      • Austin, Texas, United States, 78757
        • Recruiting
        • American Research Corporation
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneer Research Solutions Inc.
      • Katy, Texas, United States, 77494
        • Recruiting
        • R & H Clinical Research
      • Red Oak, Texas, United States, 75154
        • Recruiting
        • Epic Medical Research
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Pinnacle Clinical Research
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Endeavor Clinical Trials
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation
      • Stafford, Texas, United States, 77477
        • Recruiting
        • R & H Clinical Research
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Simcare Medical Research, LLC
      • Waco, Texas, United States, 76710
        • Recruiting
        • Impact Clinical Research
    • Utah
      • Riverton, Utah, United States, 84065
        • Recruiting
        • Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Manassas Clinical Research Center
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University Medical College of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXA1125 33.9g
33.9 g AXA1125 administered orally BID with or without food
Drug: AXA1125
AXA1125 administered BID with or without food
Placebo Comparator: Placebo
Matching Placebo administered orally BID with or without food
Drug: Placebo
Matching Placebo administered BID with or without food
Experimental: AXA1125 22.6g
22.6 g AXA1125 administered orally BID with or without food
Drug: AXA1125
AXA1125 administered BID with or without food

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in steatohepatitis
Time Frame: Baseline to Week 48
2-point improvement from baseline to Week 48 in the non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) based on a scale from 0-8 with 0 being no NASH and 8 being the highest score
Baseline to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of NASH without worsening of fibrosis
Time Frame: Baseline to week 48
The proportion of subjects with resolution of NASH with no worsening of fibrosis defined as a post-treatment ballooning score of 0 and an inflammation score of 0 or 1 on liver biopsy.
Baseline to week 48
Improvement of fibrosis by one stage without worsening of NASH
Time Frame: Baseline to week 48
The proportion of subjects who have at least a 1-stage improvement in fibrosis and no worsening of NASH based on liver biopsy 0 being no fibrosis and 4 being the worse.
Baseline to week 48
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in hepatic fat as measured by MRI
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
Time Frame: Baseline to week 48
Baseline to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axcella Health, Inc

Investigators

  • Principal Investigator: Stephen Harrison, MD, Pinnacle Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXA1125-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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