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

NCT01167088 | Terminated Phase 2

• 2 other identifiers: MTQ-LD-0012010-021368-13
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Double-blind; Placebo-controlled; Non-alcoholic fatty liver disease; NAFLD

Outcome Measures

Primary Outcomes (1)

• Percentage change in ALT (relative to baseline) at the end of the treatment period (Day 90) for MitoQ compared with placebo.

  Baseline and 3 months

Secondary Outcomes (16)

• Absolute change in ALT level (relative to baseline) at end of treatment period for MitoQ compared with placebo

  Baseline and 3 months

• The percentage of participants whose ALT levels are in the normal range at the end of the treatment period.

  3 months

• The difference in the percentage and absolute rates of change in ALT levels between MitoQ and placebo.

  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.

  Baseline and 3 months

• The change in HOMA-IR at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.

  Baseline and 3 months

Study Arms (2)

Mitoquinone mesylate tablets (MitoQ)

EXPERIMENTAL

Drug: Mitoquinone mesylate

Matching placebo tablet

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mitoquinone mesylate DRUG

2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.

Mitoquinone mesylate tablets (MitoQ)

Placebo DRUG

Placebo

Matching placebo tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the 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 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)

You may not qualify if:

• 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, 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.

Sponsors & Collaborators

• Antipodean Pharmaceuticals, Inc.: lead

Study Sites (1)

Freeman Hospital

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Chris Day, MD, PhD

  Newcastle University Medical School, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 22, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

GB (1)