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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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NAFLD

Intervention / Treatment
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* Dietary Supplement: AXA1957
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AXA1957<br>AXA1957 20.4g | Dietary Supplement: AXA1957<br>* Amino acids, food study<br>|
| Placebo Comparator: Placebo<br>Placebo 24g | Dietary Supplement: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events (AEs). | Study food product emergent adverse events (AEs). Subjects reporting >or equal to 1 study food product-emergent AE. | AEs Baseline to week 13 - Part 1 |