| Trial ID: | L0034 |
| Source ID: | NCT04235205
|
| Associated Drug: |
Elobixibat
|
| Title: |
Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g)|Drug: Elobixibat 10mg + cholestyramine powder placebo|Drug: Elobixibat placebo + cholestyramine powder 9g (cholestyramine 4g)|Drug: Elobixibat placebo + cholestyramine powder placebo
|
| Outcome Measures: |
Absolute change from baseline in serum LDL-C at Week 16|Absolute change from baseline to Week 16 in the liver fat fraction (%) as measured by MRI-PDFF|Absolute change from baseline to Week 16 in hepatic fibrosis as measured by MRE|Change from baseline to Week 16 in ALT level|Change from baseline to Week 16 in AST level|Change from baseline to Week 16 in ??-GTP level|Absolute change from baseline to Week 16 in HDL-C level|Change from baseline to Week 16 in non HDL-C level|Change from baseline to Week 16 in LDL-C/HDL-C ratio|Change from baseline to Week 16 in TG level
|
| Sponsor/Collaborators: |
Yokohama City University|EA Pharma Co., Ltd.
|
| Gender: |
All
|
| Age: |
20 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
102
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
January 29, 2020
|
| Completion Date: |
September 30, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 16, 2021
|
| Locations: |
Yokohama City University, Yokohama, Kanagawa, Japan
|
| URL: |
https://ClinicalTrials.gov/show/NCT04235205
|
