Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
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ClinicalTrials.gov Identifier: NCT04073407
Recruitment Status :
(Sponsor has determined that information it would have collected would not inform future development of a therapy with AXA 1957 for NAFLD)
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).
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
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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