Non-alcoholic Fatty Liver DiseasePhase 2MARVELNCT01167088
A Study to Compare MitoQ and Placebo to Treat Non-alcoholic Fatty Liver Disease (NAFLD)
A Phase 2 study testing Mitoquinone mesylate in people with Non-alcoholic Fatty Liver Disease, run by Antipodean Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Mitoquinone mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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.
- 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.
- Any changes to prescription medication in the 30 days prior to baseline
- A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
- Unable to swallow tablets whole
- Patients with histological or clinical evidence of established cirrhosis
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Mitoquinone mesylate, Placebo
- Keywords
- Double-blind, Placebo-controlled, Non-alcoholic fatty liver disease, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoquinone mesylateDrug
2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mitoquinone mesylate tablets (MitoQ) | Experimental | Not described Receives: Drug: Mitoquinone mesylate |
| Matching placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in ALT (relative to baseline) at the end of the treatment period (Day 90) for MitoQ compared with placebo.
Measured: 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
Measured: Baseline and 3 months
The percentage of participants whose ALT levels are in the normal range at the end of the treatment period.
Measured: 3 months
The difference in the percentage and absolute rates of change in ALT levels between MitoQ and placebo.
Measured: 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.
Measured: Baseline and 3 months
The change in HOMA-IR at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.
Measured: Baseline and 3 months
The change in HbA1c at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.
Measured: 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.
Measured: Baseline and 3 months
Areas under the ALT, AST, GGT and alkaline phosphatase curves from baseline to the end of the treatment period.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
The change in blood pressure at the end of the treatment period (relative to baseline) for MitoQ compared with placebo.
Measured: 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.
Measured: Baseline and 3 months
Incidence of adverse events
Measured: Baseline to Follow-up (total 4 months)
Clinically relevant deterioration in laboratory variables
Measured: Baseline to Follow-up (total 4 months)
Clinically relevant deterioration in vital signs
Measured: Baseline to Follow-up (total 4 months)
Clinically relevant deterioration in ECG parameters
Measured: Baseline to Follow-up (total 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: This study has been terminated due to poor participant recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antipodean Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chris Day, MD, PhD, Principal investigator, Newcastle University Medical School, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167088
- Sponsor's protocol ID
- MTQ-LD-001
- Other IDs
- 2010-021368-13
- Acronym
- MARVEL
- Status last verified
- May 2011
- First submitted
- 19 Jul 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01167088
- Acronym / sponsor ID
- MARVEL / MTQ-LD-001
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Double-blind, Placebo-controlled, Non-alcoholic fatty liver disease, NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated due to poor participant recruitment
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Antipodean Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitoquinone mesylate tablets (MitoQ) | Experimental | Drug: Mitoquinone mesylate |
| Matching placebo tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoquinone mesylate2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food. | Drug | Mitoquinone mesylate tablets (MitoQ) |
| PlaceboPlacebo | Drug | Matching placebo tablet |
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
16 secondary outcomes
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)
Results and safety
The study was stopped early (reason given: This study has been terminated due to poor participant recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Day, MD, PhD principal investigator
Newcastle University Medical School, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoquinone mesylate in people with Non-alcoholic Fatty Liver Disease, run by Antipodean Pharmaceuticals, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study has been terminated due to poor participant recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.