Trials / Terminated
TerminatedNCT04073407
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Axcella Health, Inc · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | AXA1957 | Amino acids, food study |
| DIETARY_SUPPLEMENT | Placebo | placebo |
Timeline
- Start date
- 2019-07-27
- Primary completion
- 2020-04-15
- Completion
- 2020-09-01
- First posted
- 2019-08-29
- Last updated
- 2021-09-23
- Results posted
- 2021-09-23
Locations
4 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04073407. Inclusion in this directory is not an endorsement.