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    Summary
    EudraCT Number:2008-005779-86
    Sponsor's Protocol Code Number:GFT505-208-3
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-005779-86
    A.3Full title of the trial
    A Pilot study to evaluate the Efficacy and Safety of GFT505 (80 mg) orally administered once daily for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.
    A.4.1Sponsor's protocol code numberGFT505-208-3
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGENFIT
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGFT505 20mg lactose - magnesium stearate
    D.3.2Product code GFT505
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 824932-88-9
    D.3.9.2Current sponsor codeGFT505
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    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
    Atherogenic dyslipidaemic patients with abdominal obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058108
    E.1.2Term Dyslipidaemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059179
    E.1.2Term Abdominal obesity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of GFT505 80mg in reducing serum TG and increasing HDL-C levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity.
    To assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of GFT505 80mg in reducing LDL-C and non-HDL-C levels compared with placebo.
    To describe the changes in TG, HDL-C, LDL-C and non-HDL-C levels in the two groups.
    To describe the changes in other lipid parameters in the two groups.
    To describe the changes in inflammatory, oxidative stress and renal function markers in the two groups.
    To assess the plasma exposure of GFT505 after repeated once daily administrations of GFT505.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
    1) Provide written informed consent prior to enrolment.
    2) Male or post-menopausal female (defined as >12 months since last menstrual period and with stable (at least 6 months prior to screening) and continuous Hormonal Replacement Therapy if any- surgical removal of ovaries can be considered as “surgical menopause”)).
    3) Aged from 18 to 75 years.
    4) Waist circumference ≥102cm for male, ≥ 88cm for female.
    5) Atherogenic dislipidaemia* inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise). * (documented or highly probable at V1)
    6) Patients without previous experience of CVD**.
    ** Cardiovascular disease will be defined as:
    1) Peripheral Artery Disease
    a) Lower limb [history of acute leg ischemia or clinical symptoms of arteriopathy (intermittent claudication)]
    b) Peripheral carotid artery disease [history of stroke, TIA (Transient Ischemic Attack)]
    c) Abdominal aortic aneurysm
    2) Coronary Heart Disease (Angina pectoris, history of myocardial infarction, revascularisation procedures)

    7) Non-hypertensive or patient taking antihypertensive medication (except non-permitted medication) maintained at a stable dose for 2 months at least prior to screening (and the stable dose can be maintained throughout the study).

    In addition to the above criteria, all of the following inclusion criteria must be fulfillled at V2 (or results of V2 labs):
    8) 150≤ fasting TG ≤ 600 mg/dL (1.69 ≤ fasting TG ≤ 6.78 mmol/L) at V2
    9) Fasting HDL-C ≤ 40 mg/dL (≤ 1.03 mmol/L) for male, HDL-C ≤ 45 mg/dL (≤ 1.16 mmol/L) for female at V2

    In addition to the above criteria, the following inclusion criterion must be fulfillled at V3:
    10) Patient agrees to come to following visits and it is possible to schedule V4 and V5 inside the protocol specified range (14 days +/- 2 days between V3 and V4; 14 days +/- 2 days between V4 and V5).
    E.4Principal exclusion criteria
    1) Body Mass Index (BMI) ≥ 40 kg/m².
    2) Weight change (variation >5%) within 6 months at least prior to screening.
    3) Known Heart Failure (Grade I to IV of NYHA classification).
    4) Blood Pressure > 160 / 95 mmHg.
    5) Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer.
    6) Type I or type II Diabetes Mellitus.
    7) Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease.
    8) Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
    9) Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
    10) Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study
    11) The Patient is a female of childbearing potential, is pregnant or lactating
    12) Any medication that may interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomial enzymes within 3 months prior to the screening day.
    13) Currently taking other investigational drugs or who have taken part in a clinical trial within the previous month prior to screening.
    14) Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose monohydrate, Titanium dioxide, Red Iron Oxide, Magnesium Stearate).
    15) Patient not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.
    16) Patient who cannot be contacted in case of emergency.

    In addition to the above criteria, the patient should not present any of the following exclusion criteria at V2 (or results of V2 labs):
    17) Uncontrolled hypothyroidism defined as TSH > 2 x the upper limit of normal (ULN) at V2 (thyroid dysfunction controlled for at least 6 months prior to screening is permitted).
    18) Significant renal disease, including nephritic syndrome, chronic renal failure (defined as creatinine clearance < 60 mL/mn according to Cockroft-Gault formula and serum creatinine >180 µmol/L at V2).
    19) Active liver disease or hepatic dysfunction***** as defined by elevations in liver enzymes: [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] >3 x the upper limit of normal (ULN) at V2, or [gamma glutamyltransferase (GGT) and alkaline phosphatases (ALP)] > 2 x the upper limit of normal (ULN) at V2.
    ***** Patients with NonAlcoholic SteatoHepatitis (NASH) will be allowed to participate in the study.
    20) Unexplained serum creatine phosphokinase (CPK) > 3 x the upper limit of normal (ULN) at V2. Patients with a reason for CPK elevation may continue in screening and have the measurement repeated prior to randomization; a repeat CPK > 3 x ULN is exclusionary.

    In addition to the above criteria, the patient should not present any of the following exclusion criteria at V3:
    21) Patient for whom the wash-out period of lipid-regulating drugs (fibrates, statins and other classes of lipid-regulating drugs) has not been respected or who has taken any non-permitted medication.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    - Decrease in serum TG level from baseline to D28 (V5).
    - Increase in serum HDL-C level from baseline to D28 (V5).

    Secondary Endpoints:
    - Decrease in serum non-HDL-C and LDL-C levels from baseline to D28 (V5).
    - Changes from baseline to all study visits for other lipids (TG, HDL-C, Total Cholesterol, calculated VLDL-C) and special lipids (Apo AI, Apo AII, Apo B, Apo CIII, Apo CIII/B, Apo CIII-nonB, small dense LDL, remnants, FFA, Lp(a)).
    - Changes from baseline to D28 (V5) for inflammatory markers (hsCRP, TNF-alpha, IL-6, PAI-1, gene expression in leukocytes, amyloïd A serum, Lp-PLA2, ICAM, VCAM, adiponectin, leptin), for renal function markers (alpha-1 microglobulin, beta-NAG, N-Gal, albumin, creatinin, microscopic analysis and cystatin C), for oxidative stress markers [oxysterols, Vitamin E, HODE (hydroxyoctadecadienoic acid), isoprostans, trans isomers of arachidonic acid, oxidized LDL, paraoxanase].
    - SAE, AE, physical examination, vital signs, medical history, ECG.
    - Haematology (haemoglobin, haematocrit, RBC, WBC and differential count, platelet counts, haptoglobin, prothrombin, reticulocytes count) and biochemical markers [insulin, fasting plasma glucose, creatinine, creatinine clearance, total proteins, albumin, electrolytes (sodium, potassium, chloride, calcium), uric acid, urea, AST, ALT, GGT, alkaline phosphatases, CPK, total and conjugated bilirubin, troponin I, fibrinogen, homocystein,TSH, HbA1c, fructosamin] and urinalysis.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the trial corresponds to the last patient last visit
    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 months6
    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 months6
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 90
    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 Decision2008-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-24
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