| Trial ID: | L0017 |
| Source ID: | NCT05084404
|
| Associated Drug: |
Guanabenz
|
| Title: |
Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Experimental: 4 mg/day of WY-8678 (guanabenz acetate)|Drug: Experimental: 8 mg/day of WY-8678 (guanabenz acetate)
|
| Outcome Measures: |
Percentage of those where the liver fat content (%) measured by MRI-PDFF at 16 weeks decreased by ??? 3.46% from baseline (%)|Percentage of those where the liver fat content (%) measured by MRI-PDFF at 16 weeks decreased by 3.46% or more from baseline for 4 mg group and 8 mg group (%)|The absolute change in liver fat content measured by MRI-PDFF|Rate of change in ALT|Rate of change in AST|Rate of change in gamma-glutamyl transferase (??-GTP)|Rate of change in weight|Rate of change in blood lipids|Rate of change in insulin resistance (HOMA-IR)|Rate of change in liver stiffness|Rate of change in fibrosis markers (enhanced liver fibrosis [ELF] score)|Rate of change in fibrosis markers (enhanced liver fibrosis Fibrosis-4 [FIB-4])|Occurrence rate of adverse events
|
| Sponsor/Collaborators: |
Yokohama City University
|
| Gender: |
All
|
| Age: |
20 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
28
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
October 14, 2021
|
| Completion Date: |
June 30, 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 17, 2021
|
| Locations: |
Yokohama City University, Yokohama, Kanagawa, Japan
|
| URL: |
https://ClinicalTrials.gov/show/NCT05084404
|
