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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 - Hôpital Haut-Lévêque
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axcella Health, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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