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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021368-13 | EudraCT Number |
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This study has been terminated due to poor participant recruitment
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The purpose of this study is to investigate whether a new medicine, called mitoquinone, will reduce raised liver enzymes due to NAFLD and to see if it is safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitoquinone mesylate tablets (MitoQ) | Experimental |
| |
| Matching placebo tablet | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoquinone mesylate | Drug | 2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in ALT (relative to baseline) at the end of the treatment period (Day 90) for MitoQ compared with placebo. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in ALT level (relative to baseline) at end of treatment period for MitoQ compared with placebo | Baseline and 3 months | |
| The percentage of participants whose ALT levels are in the normal range at the end of the treatment period. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Day, MD, PhD | Newcastle University Medical School, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freeman Hospital | Newcastle upon Tyne | NE2 4HH | United Kingdom |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C429014 | mitoquinone |
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| Placebo | Drug | Placebo |
|
| The difference in the percentage and absolute rates of change in ALT levels between MitoQ and placebo. | Baseline to 3 months |
| The percentage and absolute change in AST at the end of the treatment period (relative to baseline) for MitoQ compared with placebo. | Baseline and 3 months |
| The change in HOMA-IR at the end of the treatment period (relative to baseline) for MitoQ compared with placebo. | Baseline and 3 months |
| The change in HbA1c at the end of the treatment period (relative to baseline) for MitoQ compared with placebo. | Baseline and 3 months |
| 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. | Baseline and 3 months |
| Areas under the ALT, AST, GGT and alkaline phosphatase curves from baseline to the end of the treatment period. | Baseline to 3 months |
| 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. | Baseline and 3 months |
| 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. | Baseline and 3 months |
| The change in blood pressure at the end of the treatment period (relative to baseline) for MitoQ compared with placebo. | Baseline and 3 months |
| The change in blood lipid profile at the end of the treatment period (relative to baseline) for MitoQ compared with placebo. | Baseline and 3 months |
| Incidence of adverse events | Baseline to Follow-up (total 4 months) |
| Clinically relevant deterioration in laboratory variables | Baseline to Follow-up (total 4 months) |
| Clinically relevant deterioration in vital signs | Baseline to Follow-up (total 4 months) |
| Clinically relevant deterioration in ECG parameters | Baseline to Follow-up (total 4 months) |