| Trial ID: | L0601 |
| Source ID: | NCT02605616
|
| Associated Drug: |
AstraZeneca
|
| Title: |
A Randomized, Double-Blinded, Placebo-controlled Phase IIa Study to Assess the Efficacy and Safety of a Novel AstraZeneca Compound in Subjects With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease (NAFLD);Non-alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: AZ compound;Other: Placebo
|
| Outcome Measures: |
AZD4017 changes hepatic fat as compared to placebo.;AZD4017 changes hepatic conversion of [13C] cortisone to [13C] cortisol as compared to placebo.Liver fibrosis measured with MRE will be changed in subjects treated with AZD4017 as compared to placebo.;Total insulin sensitivity (Si) and hepatic insulin sensitivity (Si liver) will be changed after treatment with AZD4017 than at baseline.;Total insulin sensitivity (Si) and hepatic insulin sensitivity (Si liver) will be changed in subjects treated with AZD4017 as compared to placebo.
|
| Sponsor/Collaborators: |
University of Virginia
|
| Gender: |
All
|
| Age: |
21 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
100
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
18/09/2015
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02605616
|
