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Study of the Safety and Tolerability of AXA1125 and AXA1957 in 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. Identifier: NCT04073368
Recruitment Status : Completed
First Posted : August 29, 2019
Last Update Posted : September 4, 2020
Information provided by (Responsible Party):
Axcella Health, Inc

Brief Summary:
This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated. Subjects have non-alcoholic fatty liver disease (NAFLD) and the study 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: AXA1125 Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : September 3, 2020

Arm Intervention/treatment
Active Comparator: AXA1957 high dose
AXA1957 20.3g
Dietary Supplement: AXA1957
Amino acids, food study

Active Comparator: AXA1957 low dose
AXA1957 13.5g
Dietary Supplement: AXA1957
Amino acids, food study

Active Comparator: AXA1125
AXA1125 24g
Dietary Supplement: AXA1125
Amino acids, food study

Placebo Comparator: Placebo
Placebo 24g
Dietary Supplement: Placebo
Amino acids, food study

Primary Outcome Measures :
  1. Incidence of study product emergent adverse events (AEs)and serious adverse events (SAEs) [ Time Frame: Baseline to week 16 ]
    AEs and SAEs

Secondary Outcome Measures :
  1. Percent change in liver fat as assessed by MRI-PDFF [ Time Frame: Baseline to week 16 ]

  2. Change in HOMA-IR [ Time Frame: Baseline to week 16 ]

  3. Change in plasma glucose [ Time Frame: Baseline to week 16 ]
    Primary glucose

  4. Change in plasma insulin [ Time Frame: Baseline to week 16 ]
    Plasma Insulin

  5. Change in alanine aminotransferase (ALT) [ Time Frame: Baseline to week 16 ]

  6. Change in aspartate aminotransferase (AST) [ Time Frame: Baseline to week 16 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Key Inclusion Criteria:

  • Willing to participate in the study and provide written informed consent.
  • Male and female adults aged > 18 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 3 months prior to Screening.
  • 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 identifier (NCT number): NCT04073368

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Sponsors and Collaborators
Axcella Health, Inc
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Principal Investigator: Stephen Harrison, MD Pinnacle Clinical Research
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Responsible Party: Axcella Health, Inc Identifier: NCT04073368    
Other Study ID Numbers: AXA1125-003
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: September 4, 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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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases