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

Axcella Health

Status: Terminated

Conditions: NAFLD

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AXA1957

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073407

AXA1957-002

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups, including a placebo group

AXA1957

Active Comparator group

Description:

AXA1957 20.4g

Treatment:

Dietary Supplement: AXA1957

Placebo

Placebo Comparator group

Description:

Placebo 24g

Treatment:

Dietary Supplement: Placebo