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    Summary
    EudraCT Number:2019-000645-12
    Sponsor's Protocol Code Number:GFT505-219-8
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-000645-12
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) treatment administered once daily on hepatic lipid composition in subjects with Nonalcoholic Fatty Liver (NAFL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess the effect of a 6-week Elafibranor (120mg) treatment administered once daily on liver fat composition in subjects with Nonalcoholic Fatty Liver (NAFL).
    A.4.1Sponsor's protocol code numberGFT505-219-8
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03953456
    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 SponsorGENFIT SA
    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 supportGENFIT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGENFIT
    B.5.2Functional name of contact pointPascal Birman
    B.5.3 Address:
    B.5.3.1Street AddressParc Eurasanté - 885, avenue Eugène Avinée
    B.5.3.2Town/ cityLOOS
    B.5.3.3Post code59120
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320 16 4000
    B.5.6E-mailcontact@genfit.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 nameelafibranor
    D.3.2Product code GFT505
    D.3.4Pharmaceutical form Coated tablet
    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 INNELAFIBRANOR
    D.3.9.1CAS number 824932-88-9
    D.3.9.2Current sponsor codeGFT505
    D.3.9.4EV Substance CodeSUB187548
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) 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 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 placeboCoated tablet
    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 Nonalcoholic Fatty Liver (NAFL)
    E.1.1.1Medical condition in easily understood language
    Non-Alcoholic Fatty Liver (NAFL).
    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 22.0
    E.1.2Level LLT
    E.1.2Classification code 10029530
    E.1.2Term Non-alcoholic fatty liver
    E.1.2System Organ Class 100000004871
    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 effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    •To evaluate the between treatment difference (elafibranor 120 mg/d vs. placebo) in HGP (Hepatic Glucose Production) measured at the end of 6 weeks treatment periods.
    •To compare the changes from baseline, achieved after 6-week treatment with elafibranor 120mg/d versus placebo in:
    -Glucose homeostasis
    -Lipid metabolism
    -Inflammatory markers
    -Liver function

    Safety
    •To assess the safety and tolerability profile of 6-week elafibranor administration orally (120 mg/d) in NAFL subjects.
    -serious adverse events, adverse events, vital signs, medical history,
    -hematological parameters
    -liver markers
    -renal biomarkers
    -metabolic parameters
    -other biochemical safety markers.

    Exploratory Objectives
    •To explore whether there is an association between the decrease in SFA and improvement of hepatic insulin sensitivity after treatment with elafibranor vs. placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or post-menopausal females aged from 40-75 years inclusive at first Screening Visit. (Post-menopausal defined as: subject should be surgically sterilized at least 6 months or no spontaneous menses for at least 1 year prior to screening)
    2. Must provide signed written informed consent and agrees to comply with the study protocol.
    3. Liver fat percentage IHL ≥ 5% (as measured with 1H-MRS)
    4. 25.0 ≤ BMI ≤ 38.0 kg/m2
    5. Stable dietary habits and physical activity pattern (over 3 months prior to Screening Visit)
    6. Subject agrees not to change dietary habits and physical activity pattern, to follow diet and lifestyle recommendations and not to consume or use illicit drugs during the study up to end of treatment.
    E.4Principal exclusion criteria
    Medical history:
    1. Documented weight loss of more than 5% during the 6-month period prior to Screening Visit
    2. Contra-indications for MRI/MRS
    3. Known history of Type 1 and 2 diabetes
    4. Known chronic heart failure (Grade I to IV of New York Heart Association classification)
    5. History of clinically significant acute cardiac event within 6 months prior to Screening Visit such as: stroke, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures)
    6. Uncontrolled hypertension despite optimal antihypertensive therapy
    7. Other well documented causes of chronic liver disease according to standard diagnostic procedures.
    8. Symptoms of clinical depression
    9. Other concurrent medical (e.g., immunological, neoplastic, endocrine, hematological, gastrointestinal or neurological) or psychiatric condition, which, in the opinion of the Investigator, would place the subject at increased risk, preclude obtaining voluntary consent/assent or compliance with required study procedures, or would confound the objectives of study
    10. Known hypersensitivity to the investigation product or any of its formulation excipients

    Concomitant medications and lifestyle:
    11. Fibrates are not permitted from 8 weeks before Screening up to end of treatment. Subjects taking statins or ezetimibe prior to Screening Visit 1 may participate if the dose has been stable for 3 months prior to Screening Visit 1 and no dose adjustments are anticipated
    12. Currently taking drugs that can induce steatosis/steatohepatitis including, but not restricted to: corticosteroids (parenteral & oral chronic administration only), amiodarone (Cordarone), tamoxifen (Nolvadex), and methotrexate (Rheumatrex, Trexall), which are not permitted 30 days prior to Screening and up to end of treatment
    13. Subjects receiving thiazoledinediones (glitazones [pioglitazone, rosiglitazone])
    14. Currently taking any medication that could interfere with study medication absorption, distribution, metabolism, or excretion or could lead to induction or inhibition of microsomal enzymes, e.g., indomethacin, which are not permitted from Randomization until end of treatment
    15. Any medication use known to interfere with glucose homeostasis/metabolism
    16. Smoking
    17. Current or recent history (<5years) of significant alcohol consumption. For men, significant consumption is typically defined as higher than 30 g pure alcohol per day. For women, it is typically defined as higher than 20 g pure alcohol per day
    18. Subjects 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 month following the end of the study
    19. Is participating in any other study and have received any other investigational drug or device within 30 days prior to Screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments
    20. Subjects who cannot be contacted in case of emergency

    In addition to the above criteria, subject should not present any of the following biological exclusion criteria:
    21. Positive anti-human immunodeficiency virus (HIV) antibody
    22. Positive hepatitis B surface antigen
    23. Positive hepatitis C Virus (HCV) antibody
    24. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN)
    25. Conjugated bilirubin > 1.50mg/dL due to altered hepatic function Note: Gilbert Disease subjects are allowed into the study
    26. International normalized ratio >1.40 due to altered hepatic function
    27. Platelet count <100,000/mm3 due to portal hypertension
    28. Serum creatinine levels >1.53 mg/dL in males and >1.24 mg/dL in females
    29. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as subjects with markers of kidney damage or estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m2)
    30. Unexplained serum creatine phosphokinase (CPK) >2 x ULN. In case of explained elevated CPK >2 x ULN, the measurement can be repeated prior to Randomization. In this case, retest should be performed within 1 to 2 weeks after initial test. A CPK retest >2 x ULN leads to exclusion
    31. Hemoglobin A1c (HbA1C) > 6.4% and/or fasting plasma glucose (FGP) > 126 mg/dl
    E.5 End points
    E.5.1Primary end point(s)
    Relative amount of saturated fatty acids in the liver (%SFA) measured by 1H-MRS at the end of 6 weeks treatment periods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    •Hepatic insulin sensitivity measured by HGP (Hepatic Glucose Production) at the end of 6 weeks treatment periods.

    •Changes from baseline achieved after 6-week treatment in:
    - Glycaemic markers (Fasting glycaemia, HbA1C, Fasting insulinemia, c-peptide and HOMA-IR index, Fructosamine levels)
    - Lipid markers (Fasting TG, Total cholesterol, HDL-C, LDL-C and non-HDL-C levels, FFA)
    - Inflammatory markers (hs-CRP, fibrinogen, haptoglobin)
    - Liver function (ALT, AST, GGT, ALP, total and conjugated bilirubin)
    - Renal Function (creatinine, eGFR, urea (BUN), albumin, uric acid, total proteins)
    - Body weight, BMI, waist circumference

    Safety endpoints:
    •Incidence and severity of treatment emergent adverse events (TEAEs) and their relationship to study drug.

    •Incidence of clinically meaningful changes from baseline in safety laboratory parameters, and vital signs.

    Exploratory Endpoint
    •Correlation between the decrease in SFA and improvement of hepatic insulin sensitivity at the end of 6 weeks treatment periods.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks
    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 Yes
    E.6.13.1Other scope of the trial description
    Mechanistic
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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) No
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state16
    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)
    None
    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 Decision2019-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-07-14
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