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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.
Placebo
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Percentage change in ALT (relative to baseline) at the end of the treatment period (Day 90) for MitoQ compared with placebo.
Time frame: Baseline and 3 months
Absolute change in ALT level (relative to baseline) at end of treatment period for MitoQ compared with placebo
Time frame: Baseline and 3 months
The percentage of participants whose ALT levels are in the normal range at the end of the treatment period.
Time frame: 3 months
The difference in the percentage and absolute rates of change in ALT levels between MitoQ and placebo.
Time frame: 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.
Time frame: Baseline and 3 months
The change in HOMA-IR at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.
Time frame: Baseline and 3 months
The change in HbA1c at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.
Time frame: 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.
Time frame: Baseline and 3 months
Areas under the ALT, AST, GGT and alkaline phosphatase curves from baseline to the end of the treatment period.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months
The change in blood pressure at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.
Time frame: 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.
Time frame: Baseline and 3 months
Incidence of adverse events
Time frame: Baseline to Follow-up (total 4 months)
Clinically relevant deterioration in laboratory variables
Time frame: Baseline to Follow-up (total 4 months)
Clinically relevant deterioration in vital signs
Time frame: Baseline to Follow-up (total 4 months)
Clinically relevant deterioration in ECG parameters
Time frame: Baseline to Follow-up (total 4 months)