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    Summary
    EudraCT Number:2009-017080-41
    Sponsor's Protocol Code Number:GWMD09112
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2009-017080-41
    A.3Full title of the trial
    A randomised, partially-blind, placebo-controlled, pilot, dose-ranging study to assess the effect of cannabidiol (CBD) on liver fat levels in subjects with fatty liver disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to asses the effects of cannabidiol (CBD) on liver fat levels with people who have fatty liver disease
    A.4.1Sponsor's protocol code numberGWMD09112
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGW Pharma Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGW Pharma Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Ltd.
    B.5.2Functional name of contact pointGW Pharma Ltd. Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressPorton Down Science Park
    B.5.3.2Town/ citySalisbury, Wiltshire
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980557000
    B.5.5Fax number+441980557111
    B.5.6E-mailinfo@gwpharm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGW42003 Capsule
    D.3.2Product code EN0017
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Applicable
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeGW42003
    D.3.9.3Other descriptive nameCannabidiol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePurified extract of botanical origin
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with fatty liver disease (≥ 5% liver fat levels).
    E.1.1.1Medical condition in easily understood language
    Subjects with liver fat ≥ 5%
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10029530
    E.1.2Term Non-alcoholic fatty liver
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of cannabidiol (CBD) on liver triglyceride levels (liver fat) in subjects with fatty liver disease.
    E.2.2Secondary objectives of the trial
    To assess the effect of CBD on:
    • Lipid profile (serum Total Cholesterol, serum High-density lipoprotein (HDL), Cholesterol levels, serum HDL / Low density lipoprotein (LDL) ratio, serum triglycerides)
    • Body weight & Body Mass Index (BMI)
    • Adipose tissue distribution (body fat content, visceral adiposity, waist circumference, waist-to-hip ratio, neck circumference and skin fold thickness)
    • Glucose control (fasting plasma glucose levels)
    • Insulin sensitivity (fasting serum insulin levels)
    •The variables for proof of exposure to CBD (the change from baseline to end of treatment in plasma CBD levels)
    To assess the safety and tolerability of CBD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subject is willing and able to give informed consent for participation in the study
    •Subject is aged 18 years or above
    •Subjects with a liver fat content of equal to or above 5% as measured by MRI/MRS or biopsy within two months of screening or willing to undergo an MRI/MRS scan at Visit 1to confirm a liver fat content of equal to or above 5%
    • In the opinion of the investigator, no changes in levels of exercise for four weeks and diet (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment and subject agrees to keep stable for the duration of the study
    • Subject is able (in the investigator’s opinion) and willing to comply with all study requirements
    • Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable
    • Subject is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study
    E.4Principal exclusion criteria
    • Clinical diagnosis or treatment for Type I / II diabetes
    • Subject has received an unapproved IMP within the 30 days prior to the screening visit
    • Currently receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study
    •Currently using or has used recreational cannabis, medicinal cannabis or cannabinoid medications (including Sativex®), within one month prior to study entry and unwilling to abstain for the duration for the study
    • Any known or suspected history of:
    - alcohol or substance abuse
    - epilepsy or recurrent seizures
    • Any known or suspected history of major depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression – in the opinion of the investigator)
    • Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator
    • Known history of Hepatitis B or C
    • Genetic dyslipidaemia in the opinion of the investigator
    • Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject’s ability to participate in the study
    • Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s)
    • Presence of any metal implants
    • Any known or suspected history of claustrophobia
    • Female subjects of child bearing potential not able or willing to use effective contraception for the duration of the study and for three months thereafter or male subjects whose partner is of child bearing potential, who are not willing to ensure that they or their partner use effective contraception during the study and for three months thereafter
    • Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
    • Weighing >150 kg
    • Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator would prevent the subject from safe participation in the study
    • Unwilling to abstain from donation of blood during the study
    • Travel outside the country of residence planned during the study
    Subject has previously enrolled into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Liver triglyceride levels (liver fat) after 8 weeks of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 57 (End of week 8)
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • Fasting lipid profile (serum Total Cholesterol, serum HDL Cholesterol levels, serum HDL / LDL ratio, serum triglycerides)
    • Body weight & BMI
    • Adipose tissue distribution (body fat content, visceral adiposity, waist
    circumference, waist-to-hip ratio, neck circumference and skin fold thickness)
    • Glucose control (fasting plasma glucose levels)
    • Insulin sensitivity (fasting serum insulin levels)
    Safety and tolerability assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 57 (End of week 8 for safety and tolerability, follow up at day 64 week 9)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Partially blind, pilot, dose-ranging study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal standard of care will resume as clinical evidence of the efficacy of these medicines in this population of participants has yet to be determined.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-13
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