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NCT04073368 · ClinicalTrials.gov registry record · NA
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
A NA study, sponsored by Axcella Health.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT04073368: Completed NA study, sponsored by Axcella Health.
NCT04073368 is a NA study that has completed, run by Axcella Health. The registered enrollment target is 112 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04073368, a NA study, has completed, sponsored by Axcella Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study 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).
Primary Outcome
Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT AXA1957
- DIETARY_SUPPLEMENT AXA1125
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2020-09-03 |
| Phase | NA |
What the finished NCT04073368 record still lists
NCT04073368 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04073368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04073368 about?
NCT04073368 is a clinical study titled "Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)". 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 (MR...
What is the current status of trial NCT04073368?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2018-12-03. Estimated completion is 2020-09-03.
What interventions are being tested in trial NCT04073368?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), AXA1957 (DIETARY_SUPPLEMENT), AXA1125 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04073368?
This trial is sponsored by Axcella Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04073368's enrollment target sits among peer trials
112 813th of 2000 higher than 1,185 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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