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

This study has been terminated.
(This study has been terminated due to poor participant recruitment)
Sponsor:
Information provided by:
Antipodean Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01167088
First received: July 19, 2010
Last updated: May 28, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-alcoholic Fatty Liver Disease
 Drug: Mitoquinone mesylate
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Liver Disease (NAFLD)

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Antipodean Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in ALT level (relative to baseline) at end of treatment period for MitoQ compared with placebo [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • The percentage of participants whose ALT levels are in the normal range at the end of the treatment period. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The difference in the percentage and absolute rates of change in ALT levels between MitoQ and placebo. [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Baseline to Follow-up (total 4 months) ] [ Designated as safety issue: Yes ]
  • Clinically relevant deterioration in laboratory variables [ Time Frame: Baseline to Follow-up (total 4 months) ] [ Designated as safety issue: Yes ]
  • Clinically relevant deterioration in vital signs [ Time Frame: Baseline to Follow-up (total 4 months) ] [ Designated as safety issue: Yes ]
  • Clinically relevant deterioration in ECG parameters [ Time Frame: Baseline to Follow-up (total 4 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: November 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mitoquinone mesylate tablets (MitoQ) Drug: Mitoquinone mesylate
2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.
Placebo Comparator: Matching placebo tablet Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent
  2. 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 the previous 12 months).
  3. Be aged between 18 - 70 years on the day of consent
  4. 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
  5. Female patients with reproductive potential must have a negative 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)

Exclusion Criteria:

  1. Alcohol consumption > 14 units/week for females and 21 units/week for males
  2. Hepatocellular carcinoma (HCC) or suspicion of HCC
  3. Presence of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV)
  4. Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome
  5. Chronic pancreatitis
  6. Hospitalization for liver disease within 60 days of the baseline visit
  7. Previously diagnosed diabetes / treatment with insulin sensitizing agents
  8. Severe or morbid obesity (BMI>40kg/m2)
  9. ALT or AST > 10 times ULN
  10. Liver transplant recipients
  11. Corticosteroids in the past 30 days
  12. 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
  13. 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
  14. Females who are pregnant or breastfeeding
  15. Use of Coenzyme Q10, either prescribed or purchased over-the-counter, are 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.
  16. Use of Vitamin E, either prescribed or purchased over-the-counter, are 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.
  17. Any changes to prescription medication in the 30 days prior to baseline
  18. A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
  19. Unable to swallow tablets whole
  20. Patients with histological or clinical evidence of established cirrhosis
  21. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167088

Locations
United Kingdom
Freeman Hospital
Newcastle-upon-Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Antipodean Pharmaceuticals, Inc.
Investigators
Principal Investigator: Chris Day, MD, PhD Newcastle University Medical School, UK
  More Information

No publications provided

Responsible Party: Dr Ken Taylor, CEO, Antipodean Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01167088     History of Changes
Other Study ID Numbers: MTQ-LD-001, 2010-021368-13
Study First Received: July 19, 2010
Last Updated: May 28, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Antipodean Pharmaceuticals, Inc.:
Double-blind
Placebo-controlled
Non-alcoholic fatty liver disease
NAFLD

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013