Clinical Trial: A Study to Compare MitoQ and Placebo to Treat Non-alcoholic Fatty Liver Disease (NAFLD)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official 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 Li

Brief Summary: 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.

Detailed Summary:
Sponsor: Antipodean Pharmaceuticals, Inc.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. [ 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) ]


Original Secondary Outcome: Same as current

Information By: Antipodean Pharmaceuticals, Inc.

Dates:
Date Received: July 19, 2010
Date Started: November 2010
Date Completion: July 2011
Last Updated: May 28, 2011
Last Verified: May 2011