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    Summary
    EudraCT Number:2010-023219-32
    Sponsor's Protocol Code Number:GFT505-210-6
    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:2010-11-05
    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 number2010-023219-32
    A.3Full title of the trial
    A Pilot study to evaluate the Efficacy of GFT505 (80mg) orally administered once daily for 8 weeks on insulin sensitivity and hepatic glucose production using a glucose clamp technique and Safety in patients with insulin resistance and abdominal obesity.
    A Multicentre, Randomised, Single Blind, Placebo-Controlled, cross over study.
    A.4.1Sponsor's protocol code numberGFT505-210-6
    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
    Patients with insulin resistance and abdominal obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10036481
    E.1.2Term Pre-diabetes
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10059179
    E.1.2Term Abdominal obesity
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10022489
    E.1.2Term Insulin resistance
    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 in each patient the differences in GIR (Glucose Infusion Rate) & HGP (Hepatic Glucose Production), measured at the end of 8 weeks treatment periods with GFT505 (80 mg/d per os) or placebo according to a cross-over design.
    - To compare the changes from baseline to endpoint in GIR (Glucose Infusion Rate) & HGP (Hepatic Glucose Production). The same baseline will be used for the 2 periods.
    E.2.2Secondary objectives of the trial
    - To compare the changes from baseline, achieved after 8-week treatment with GFT505 80mg/d versus placebo in:
    - Glucose homeostasis
    - Lipid metabolism
    - Inflammatory markers and others parameters
    - Liver function (Non-Alcoholic Fatty Liver Disease markers)
    - To compare the changes from baseline in parameters associated with the glucose clamp procedures (GIR, HGP…) achieved at the end of the first 8-week treatment period in the two groups.
    - To compare gene expression (insulin signaling, lipid and glucose metabolism) in muscular tissue biopsy collected at the end of the first treatment period in the two groups.
    - To assess the safety of once-a-day administrations of oral doses of GFT505 80mg during 8 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent prior to enrolment.
    2. Male.
    3. Aged from 18 to 75 years.
    4. Waist circumference ≥94cm.
    5. BMI ≤ 45kg/m2
    6. HOMA-IR > 3
    7. Patients with diet and physical exercise stable within 3 months prior to screening.
    8. 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).
    E.4Principal exclusion criteria
    1. Blood Pressure > 160 / 95 mmHg.
    2. Known Heart Failure (Grade I to IV of NYHA classification).
    3. Patients who had an acute cardiovascular episode within 6 months prior to the start of the trial, or with a history of coronary angioplasty, stroke, TIA (Transient Ischemic Attack)], Coronary Heart Disease (Angina pectoris, history of myocardial infarction, revascularisation procedures)
    4. Diabetes mellitus type 1 or 2.
    5. Historical of bariatric surgery
    6. Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease.
    7. 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
    8. Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose monohydrate, Titanium dioxide, Red Iron Oxide, Magnesium Stearate).
    9. 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.
    10. Patients who smoke more than 10 cigarettes per day
    11. 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.
    12. Patient not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.
    13. Patient who cannot be contacted in case of emergency.
    14. 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.
    15. Patient who has taken any non-permitted medication.
    16. Patient treated with a lipid-decreasing medication (apart from statins and ezetimibe) - Note that : Patients using statins (except fluvastatin) and/or ezetimibe before the inclusion may participate if the dose is constant and stable at least for 3 months prior screening and remains constant during the study.
    17. Currently taking other investigational drugs or who have taken part in a clinical trial within the previous month prior to screening.
    18. A fasting plasma triglycerides concentration>400mg/dL or a plasma LDL-c concentration>220mg/dL
    19. Uncontrolled hypothyroidism defined as TSH > 2X the upper limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to screening is permitted.
    20. Significant renal disease, including nephritic syndrome, chronic renal failure (defined as creatinine clearance < 60 mL/mn according to MDRD formula and/or serum creatinine >180 μmol/L).
    21. Active liver disease or hepatic dysfunction as defined by elevations in liver enzymes: [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT)>3X the upper limit of normal (ULN).
    22. Unexplained serum creatine phosphokinase (CPK) > 2X the upper limit of normal (ULN). Patients with a reason for CPK elevation may continue in screening and have the measurement repeated prior to randomisation; a repeat CPK > 2X ULN is exclusionary.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    - To evaluate in each patient the differences in GIR (Glucose Infusion Rate) & HGP (Hepatic Glucose Production), measured at the end of 8 weeks treatment periods with GFT505 (80 mg/d per os) or placebo according to a cross-over design.
    - To compare the changes from baseline to endpoint in GIR (Glucose Infusion Rate) & HGP (Hepatic Glucose Production). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.

    Secondary Endpoints:
    - To evaluate in each patient the differences in other parameters measured during the glucose clamp procedures performed at the end of 8 weeks treatment periods with GFT505 (80 mg/d per os) or placebo according to a cross over design.
    - O2 consumption and CO2 production (indirect calorimetry)
    - Percentage of lean mass and fat mass (impedancemetry)
    - Free fatty acid and triglycerides response following insulin infusion during clamps
    - To compare in each patient the changes from baseline, achieved after 8-week treatment with GFT505 80mg/d versus placebo in:
    - Fasting glycaemia, HbA1C, insulinemia, c-peptide and HOMA-IR index, Fructosamine levels;
    - Fasting TG, Total cholesterol, HDL-C, LDL-C and non-HDL-C levels;
    - Inflammatory markers (fibrinogen, haptoglobin);
    - Liver functions: ALT, AST, GGT.
    - To compare the changes from baseline in parameters associated with the glucose clamp procedures (GIR, HGP…) achieved at the end of the first 8-week treatment period in the two groups : GIR, HGP, FFA and TG response during clamps.
    - To compare gene expression (insulin signalling, lipid and glucose metabolism) in muscular tissue biopsy collected at the end of the first treatment period in the two groups.
    - To evaluate the safety of once-a-day administrations of oral doses of GFT505 80mg during 8 weeks, SAE, AE, physical examination, vital signs, medical history, ECG, haematology, biochemical markers.
    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 No
    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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned2
    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 Information not present in EudraCT
    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 months8
    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 months8
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    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 state20
    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 Decision2010-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-21
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