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

NCT04073407 | Terminated Results

• 1 other identifier: AXA1957-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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).

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AXA1957

ACTIVE COMPARATOR

AXA1957 20.4g

Dietary Supplement: AXA1957

Placebo

PLACEBO COMPARATOR

Placebo 24g

Dietary Supplement: Placebo

Interventions

AXA1957 DIETARY_SUPPLEMENT

Amino acids, food study

AXA1957

Placebo DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axcella Health, Inc: lead

Study Sites (4)

Royal London Children's Hospital

London, E1 1BB, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, United Kingdom

Location

Univeristy of Southhampton

Southampton, S016 6YD, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Margaret Koziel, MD
• Organization: Axcella Health, Inc

clinicaltrials@axcellahealth.com

8573202200

Study Officials

• Saul Faust, MBBS MRCPCH PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: July 27, 2019
• Primary Completion: April 15, 2020
• Study Completion: September 1, 2020
• Last Updated: September 23, 2021
• Results First Posted: September 23, 2021

Record last verified: 2021-08

Locations

GB (4)