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

NAFLD Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04073407
• Other study ID #: AXA1957-002
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2021
• Source: Axcella Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 1, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NAFLD

Intervention

Dietary Supplement:
• AXA1957
Amino acids, food study
• Placebo
placebo

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London
United Kingdom	Royal London Children's Hospital	London
United Kingdom	Royal Manchester Children's Hospital	Manchester
United Kingdom	Univeristy of Southhampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Axcella Health, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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