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Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04073407
Recruitment Status : Terminated (Sponsor has determined that information it would have collected would not inform future development of a therapy with AXA 1957 for NAFLD)
First Posted : August 29, 2019
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Axcella Health, Inc

Brief Summary:
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated. Subjects will be adolescents with non-alcoholic fatty liver disease (NAFLD), and it will also examine liver biology using blood tests and magnetic resonance imaging (MRI).

Condition or disease Intervention/treatment Phase
NAFLD Dietary Supplement: AXA1957 Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects With Fatty Liver
Actual Study Start Date : July 27, 2019
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : September 1, 2020


Arm Intervention/treatment
Active Comparator: AXA1957
AXA1957 20.4g
Dietary Supplement: AXA1957
Amino acids, food study

Placebo Comparator: Placebo
Placebo 24g
Dietary Supplement: Placebo
placebo




Primary Outcome Measures :
  1. Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline to week 13 ]
    AEs and SAEs


Secondary Outcome Measures :
  1. Percent change in liver fat as assessed by MRI-PDFF [ Time Frame: Baseline to week 13 ]
    MRI-PDFF

  2. Change in HOMA-IR [ Time Frame: Baseline to week 13 ]
    HOMA-IR

  3. Change in plasma glucose [ Time Frame: Baseline to week 13 ]
    Plasma Glucose

  4. Change in plasma insulin [ Time Frame: Baseline to week 13 ]
    Plasma insulin

  5. Change in alanine aminotransferase (ALT) [ Time Frame: Baseline to week 13 ]
    ALT

  6. Change in aspartate aminotransferase (AST) [ Time Frame: Baseline to week 13 ]
    AST



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Willing to participate in the study and provide written informed consent.
  • Male and female adolescent subjects aged 12 to 17 years
  • Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 30 days prior to Screening.
  • Non alcoholic fatty liver disease
  • Diabetes or prediabetes
  • A screening MRI consistent with liver inflammation and fibrosis

Key Exclusion Criteria:

  • Current or history of significant alcohol consumption
  • History or presence of liver disease (other than NAFLD/NASH)
  • History or presence of cirrhosis and/or history or presence of hepatic decompensation
  • Any diabetes other than Type 2
  • Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure > 100 mmHg)
  • Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.),
  • Unable or unwilling to adhere to contraception requirements
  • Any contraindications to a MRI scan
  • Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion

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): NCT04073407


Locations
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United Kingdom
Royal London Children's Hospital
London, United Kingdom, E1 1BB
King's College Hospital
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Univeristy of Southhampton
Southampton, United Kingdom, S016 6YD
Sponsors and Collaborators
Axcella Health, Inc
Investigators
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Principal Investigator: Saul Faust, MBBS MRCPCH PhD University of Southampton
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Responsible Party: Axcella Health, Inc
ClinicalTrials.gov Identifier: NCT04073407    
Other Study ID Numbers: AXA1957-002
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases