| Trial ID: | L0140 |
| Source ID: | NCT02681055
|
| Associated Drug: |
MN-001
|
| Title: |
Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis|Hypertriglyceridemia|Non-alcoholic Fatty Liver Disease|Hypercholesterolemia
|
| Interventions: |
Drug: MN-001
|
| Outcome Measures: |
To measure the change from baseline at 12 weeks of MN-001 on Cholesterol Efflux Capacity in NASH subjects with hypertriglyceridemia|To measure the change from baseline at 12 weeks of MN-001 on serum triglyceride levels in NASH subjects with hypertriglyceridemia|To measure the safety and tolerability of MN-001 by assessing the number of treatment-related adverse events.|To measure blood the concentration of MN-001/MN-002 (metabolite) change from pre-dose after 24 hours|To measure the effect of MN-001 on serum lipid panel|To measure the effect of MN-001/002 on liver enzymes|To measure the effect of MN-001/002 on percentage of fat in the liver by MRI from baseline to Week 12
|
| Sponsor/Collaborators: |
MediciNova
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
19
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
March 2016
|
| Completion Date: |
October 1, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 22, 2020
|
| Locations: |
Southern California Research Center, Coronado, California, United States|Scripps Research, La Jolla, California, United States|Harborview Medical Center, Seattle, Washington, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02681055
|