| Trial ID: | L0733 |
| Source ID: | NCT04073407
|
| Associated Drug: |
AXA1957
|
| Title: |
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
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD
|
| Interventions: |
Dietary Supplement: AXA1957;Dietary Supplement: Placebo
|
| Outcome Measures: |
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)Percent change in liver fat as assessed by MRI-PDFF;Change in HOMA-IR;Change in plasma glucose;Change in plasma insulin;Change in alanine aminotransferase (ALT);Change in aspartate aminotransferase (AST)
|
| Sponsor/Collaborators: |
Axcella Health, Inc
|
| Gender: |
All
|
| Age: |
12 Years17 Years
|
| Phases: |
Not applicable
|
| Enrollment: |
9
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
|
| Start Date: |
27/08/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT04073407
|
