CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
AXA1957 +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04073368
NCT04073368N/ACompleted

A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

Axcella Health, Inc·interventional·Posted Aug 29, 2019·Updated Jul 6, 2021

In Brief

A clinical study evaluating AXA1957, AXA1125, and 1 other intervention for NAFLD. Completed, enrolled 112 participants across 18 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNAFLD
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 29, 2019
Enrollment StartDec 3, 2018
Primary CompletionMar 31, 2020
Study CompletionSep 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.8 years ago

Interventions

AXA1957dietary

Amino acids, food study

AXA1125dietary

Amino acids, food study

Placebodietary

Amino acids, food study