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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antipodean Pharmaceuticals, Inc.

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