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Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT04073368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-07-06

Study results available
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Summary

This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated. Subjects have non-alcoholic fatty liver disease (NAFLD) and the study will also examine liver biology using blood tests and magnetic resonance imaging (MRI).

Conditions

  • NAFLD

Interventions

DIETARY_SUPPLEMENT

AXA1957

Amino acids, food study

DIETARY_SUPPLEMENT

AXA1125

Amino acids, food study

DIETARY_SUPPLEMENT

Placebo

Amino acids, food study

Sponsors & Collaborators

  • Axcella Health, Inc

    lead INDUSTRY

Principal Investigators

  • Stephen Harrison, MD · Pinnacle Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2020-03-31
Completion
2020-09-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073368 on ClinicalTrials.gov