| Trial ID: | L0011 |
| Source ID: | NCT01167088
|
| Associated Drug: |
Mitoquinone mesylate
|
| Title: |
A Study to Compare MitoQ and Placebo to Treat Non-alcoholic Fatty Liver Disease (NAFLD)
|
| Acronym: |
MARVEL
|
| Status: |
Terminated
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Mitoquinone mesylate|Drug: Placebo
|
| Outcome Measures: |
Percentage change in ALT (relative to baseline) at the end of the treatment period (Day 90) for MitoQ compared with placebo.|Absolute change in ALT level (relative to baseline) at end of treatment period for MitoQ compared with placebo|The percentage of participants whose ALT levels are in the normal range at the end of the treatment period.|The difference in the percentage and absolute rates of change in ALT levels between MitoQ and placebo.|The percentage and absolute change in AST at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|The change in HOMA-IR at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|The change in HbA1c at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|The percentage and absolute change in GGT and alkaline phosphatase at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|Areas under the ALT, AST, GGT and alkaline phosphatase curves from baseline to the end of the treatment period.|The change in markers of liver inflammation (leptin and adiponectin) at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|The change in biomarkers of mitochondrial function and oxidative damage (isoprostanes) at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|The change in blood pressure at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|The change in blood lipid profile at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.|Incidence of adverse events|Clinically relevant deterioration in laboratory variables|Clinically relevant deterioration in vital signs|Clinically relevant deterioration in ECG parameters
|
| Sponsor/Collaborators: |
Antipodean Pharmaceuticals, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
110
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
November 2010
|
| Completion Date: |
July 2011
|
| Results First Posted: |
--
|
| Last Update Posted: |
June 1, 2011
|
| Locations: |
Freeman Hospital, Newcastle-upon-Tyne, United Kingdom
|
| URL: |
https://ClinicalTrials.gov/show/NCT01167088
|
