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

Not Applicable

Terminated

• Conditions: NAFLD
• Interventions: Dietary Supplement: AXA1957; Dietary Supplement: Placebo

• Registration Number: NCT04073407
• Lead Sponsor: Axcella Health, Inc

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-27
• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Primary Completion: 2020-04-15
• Study Completion: 2020-09-01
• Status Verified: 2021-08
• Results First Submitted: 2021-08-03
• Results First Submitted QC: 2021-08-30
• Last Update Submitted: 2021-08-30
• Results First Posted: 2021-09-23
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXA1957	AXA1957	AXA1957 20.4g
Placebo	Placebo	Placebo 24g

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events (AEs).	AEs Baseline to week 13 - Part 1	Study food product emergent adverse events (AEs). Subjects reporting \>or equal to 1 study food product-emergent AE.

Trial Locations

Locations (4)

Royal London Children's Hospital; 🇬🇧 London, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, United Kingdom

Univeristy of Southhampton; 🇬🇧 Southampton, United Kingdom