MitoQ from Antipodean in Raised Values of Enzymes of the Liver-MARVEL
Research type
Research Study
Full title
A Double-blind Randomised Placebo-controlled Multicentre Study of 40mg MitoQ and Placebo for the Treatment of Participants with Raised Liver Enzymes due to Non-Alcoholic Fatty Liver Disease (NAFLD)
IRAS ID
60411
Contact name
Christopher Paul Day
Sponsor organisation
Antipodean Pharmceuticals
Eudract number
2010-021368-13
Clinicaltrials.gov Identifier
Research summary
This is an early phase (2b) study of a novel drug, MitoQ, for the treatment of patients with raised liver enzymes (raised Alanine aminotransferase enzyme (ALT)) as the result of non-alcoholic fatty liver disease (NAFLD). The main aim of the study is to examine the effect of MitoQ on raised ALT; it is proposed that the drug will lead to a lowering in ALT. Secondary aims are to measure the effect of MitoQ on other indicators of liver disease and insulin sensitivity in people with NAFLD, and to check on how safe this drug is. In this study, approximately 110 patients with NAFLD will be randomised to receive MitoQ (40 mg per day for 90 days) or a matched placebo (a dummy tablet that looks like MitoQ, but has no active ingredients). They will take the study tablets for 90 days, and will be seen regularly over that period, with a final follow-up 30 days after finishing the study tablets. At each study visit, blood samples will be taken and analysed to measure ALT levels and other aspects of liver function, and patients will be asked about any symptoms or other health problems that might be side effects of MitoQ. The main analysis will be a comparison of the percentage change in MitoQ, from baseline to the end of the 90 day treatment period for patients taking MitoQ versus those taking placebo. Other analyses will focus on changes for the MitoQ group versus the placebo group in other measures of liver function and insulin sensitivity.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
10/H0904/52
Date of REC Opinion
28 Sep 2010
REC opinion
Favourable Opinion