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

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ClinicalTrials.gov Identifier: NCT04880187
Recruitment Status : Recruiting
First Posted : May 10, 2021
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Axcella Health, Inc

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis (NASH) Drug: AXA1125 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AXA1125 22.6g
22.6 g AXA1125 administered orally BID with or without food
 Drug: AXA1125
AXA1125 administered BID with or without food
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline to week 48 ]
  4. Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™) [ Time Frame: Baseline to week 48 ]
  5. Change from baseline in hepatic fat as measured by MRI [ Time Frame: Baseline to week 48 ]
  6. Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c) [ Time Frame: Baseline to week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880187


Contacts
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Contact: Margaret Koziel, MD (857) 320-3200 clinicaltrials@axcellahealth.com

Locations
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Sponsors and Collaborators
Axcella Health, Inc
Investigators
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Principal Investigator: Stephen Harrison, MD Pinnacle Clinical Research
More Information
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Additional Information:

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Responsible Party: Axcella Health, Inc
ClinicalTrials.gov Identifier: NCT04880187    
Other Study ID Numbers: AXA1125-101
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axcella Health, Inc:
Steatosis
Lobular inflammation
Ballooning
Liver biopsy
Liver fat
 Liver stiffness
NASH
Aminio Acids
Fibrosis
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases