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

Primary Purpose

NAFLD

Status

Terminated

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

AXA1957

Placebo

About this trial

This is an interventional basic science trial for NAFLD

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

Royal London Children's Hospital
King's College Hospital
Royal Manchester Children's Hospital
Univeristy of Southhampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AXA1957

Placebo

Arm Description

AXA1957 20.4g

Placebo 24g

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04073407

First Posted

August 27, 2019

Last Updated

August 30, 2021

Sponsor

Axcella Health, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04073407

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Why Stopped

Sponsor has determined that information it would have collected would not inform future development of a therapy with AXA 1957 for NAFLD

Study Start Date

July 27, 2019 (Actual)

Primary Completion Date

April 15, 2020 (Actual)

Study Completion Date

September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Axcella Health, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NAFLD

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AXA1957

Arm Type

Active Comparator

Arm Description

AXA1957 20.4g

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 24g

Intervention Type

Dietary Supplement

Intervention Name(s)

AXA1957

Intervention Description

Amino acids, food study

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Number of Subjects With Adverse Events (AEs).

Description

Study food product emergent adverse events (AEs). Subjects reporting >or equal to 1 study food product-emergent AE.

Time Frame

AEs Baseline to week 13 - Part 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saul Faust, MBBS MRCPCH PhD

Organizational Affiliation

University of Southampton

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal London Children's Hospital

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

King's College Hospital

City

London

Country

United Kingdom

Facility Name

Royal Manchester Children's Hospital

City

Manchester

Country

United Kingdom

Facility Name

Univeristy of Southhampton

City

Southampton

ZIP/Postal Code

S016 6YD

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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