E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Raised Liver Enzymes due to Non-Alcoholic Fatty Liver Disease (NAFLD) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029530 |
E.1.2 | Term | Non-alcoholic fatty liver |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to measure the effect of MitoQ on raised ALT (liver enzyme) due to NAFLD
|
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to measure the effect of MitoQ on other indicators of liver disease and insulin sensitivity in this population.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Provide written informed consent - NAFLD as determined by raised ALT (> 1.5 x ULN [corresponding to >29U/L for females and >45U/L for males] in the screening period and on at least two other occasions in the previous 6 months) and ultrasound evidence of steatosis (in previous 12 months). - Be aged between 18 – 70 years on the day of consent - Expect to not require or make any changes in all their current concomitant medications (prescribed and over-the-counter) for the duration of their participation in the study - Female patients with reproductive potential must have a negative urine or serum pregnancy test within 14 days prior to start of trial and must agree to use a medically acceptable method of contraception throughout the treatment period and for 1 month after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary |
|
E.4 | Principal exclusion criteria |
Alcohol consumption > 14 units/week for females and 21 units/week for males Hepatocellular carcinoma (HCC) or suspicion of HCC Presence of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV) Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome Chronic pancreatitis Hospitalization for liver disease within 60 days of the baseline visit Previously diagnosed diabetes / treatment with insulin sensitizing agents Severe or morbid obesity (BMI>40kg/m2) ALT or AST > 10 times ULN Liver transplant recipients Corticosteroids in the past 30 days Any participant who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial A history of a malignancy other than treated basal cell or squamous cell carcinoma of the skin; those with a history of malignancy that has been treated with no recurrence within the last 2 years are not excluded Females who are pregnant or breastfeeding Use of Coenzyme Q10, either prescribed or purchased over-the-counter, is prohibited during the study, except for doses of up to 25mg/day which have been stable for 30 days prior to baseline. Higher doses require a 7 day washout prior to baseline. Use of Vitamin E, either prescribed or purchased over-the-counter, is prohibited during the study, except for doses of up to 200IU/day which have been stable for 30 days prior to baseline. Higher doses require a 90 day washout prior to baseline. Any changes to prescription medication in the 30 days prior or baseline. Participant with a history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone Unable to swallow tablets whole Patients with histological or clinical evidence of established cirrhosis Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the patient’s best interest to participate in this study’.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change in ALT level (relative to baseline) at end of treatment period for MitoQ compared with placebo |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |