| Trial ID: | L0734 |
| Source ID: | NCT04073368
|
| Associated Drug: |
AXA1957
|
| Title: |
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)
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT04073368
|
| Conditions: |
NAFLD
|
| Interventions: |
Dietary Supplement: AXA1957;Dietary Supplement: AXA1125;Dietary Supplement: Placebo
|
| Outcome Measures: |
Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs)Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF);Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR);Change in Glucose Homeostasis;Relative Change in Alanine Aminotransferase (ALT);Change in Aspartate Aminotransferase (AST)
|
| Sponsor/Collaborators: |
Axcella Health, Inc
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Not applicable
|
| Enrollment: |
112
|
| 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: |
02/07/2021
|
| Last Update Posted: |
12 July 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04073368
|
