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    Summary
    EudraCT Number:2018-003119-22
    Sponsor's Protocol Code Number:EYP001-202
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-13
    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 number2018-003119-22
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating safety, tolerability and efficacy of the experimental drug EYP001a in patients with non-alcoholic steatohepatitis
    A.4.1Sponsor's protocol code numberEYP001-202
    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 SponsorENYO Pharma 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 supportENYO Pharma SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationENYO Pharma SA
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressBâtiment B - Bioserra, 60 Avenue Rockefeller
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69008
    B.5.3.4CountryFrance
    B.5.4Telephone number33437 700 219
    B.5.6E-mail202@enyopharma.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 nameN/A
    D.3.2Product code EYP001a
    D.3.4Pharmaceutical form 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 INNNot yet assigned
    D.3.9.1CAS number 1192171-69-9
    D.3.9.2Current sponsor codeEYP001a
    D.3.9.3Other descriptive nameEYP001A
    D.3.9.4EV Substance CodeSUB189131
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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 placeboTablet
    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
    Nonalcoholic steatohepatitis with likely stage F2 to F3 fibrosis
    E.1.1.1Medical condition in easily understood language
    Nonalcoholic steatohepatitis, a disease characterized by the presence of an abnormal accumulation of fat in the liver
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    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
    The primary objective is to determine the efficacy and safety profiles of
    EYP001a versus placebo on liver fat content (LFC) from baseline to Week
    12 in patients with NASH.
    E.2.2Secondary objectives of the trial
    • To explore the pharmacokinetics (PK) of EYP001a
    • To evaluate pharmacodynamic (PD) effects of EYP001a on bile acidrelated
    markers as appropriate
    • To assess the effects of EYP001a on lipid and metabolic profiles
    • To assess the safety of EYP001a with statin coadministration
    • To assess the effects of EYP001a on noninvasive biomarkers of liver fibrosis and inflammation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provides signed written informed consent and agrees to comply with the study protocol.
    2. Is a male or female aged 18 years or older.
    3. Has a suspected diagnosis of NASH during the Screening Period (up to 12 weeks before dosing), defined as follows:
    a. The average baseline serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values should be established by at least 2 samples obtained at least 4 weeks and no more than 12 weeks apart. One sample can be obtained from the patient's medical history and 1 sample can be obtained during the Screening Period, or both samples can be obtained during the Screening Period. If the values of ALT or AST in both samples
    are within normal ranges, the variability of the marker is assumed adequate for randomization. If the values of ALT or AST are higher than normal values, the patient will be eligible for enrollment provided the increase from the first to second sample is =< 40%. If the values from sample 1 are higher than those from sample 2 (ie. there is a decrease), the patient will be eligible despite a > 40% difference. A third sample can be collected if an increase from sample 1 to sample 2 exceeds the 40% limit. If sample 3 exceeds the 40% limit (compared to sample 1), this increase shall prompt to the search of clinical signs or symptoms of liver impairment, and the patient will not be eligible for enrollment. Baseline AST values should be > 20 U/L.
    b. Normal average baseline levels of alkaline phosphatase (ALP). Total bilirubin (TBL) levels should be =< 22.2 umol/L (1.3 mg/dL).
    c. Liver stiffness compatible with liver fibrosis stage F2 or F3 determined by FibroScan® vibration-controlled transient elastography assessment
    cut-off value >= 8.5 kPa.
    d. FibroScan controlled attenuation parameter (CAP) for steatosis with cut-off values >300 dB/m.
    e. LFC >=10% as measured by MRI PDFF.
    4. Is not of childbearing potential (as defined in Inclusion Criterion 5) or, if of childbearing potential, is not pregnant as confirmed by a negative
    serum human chorionic gonadotropin test at screening and is not planning a pregnancy during the course of the study.
    5. Women of childbearing potential and male patients with female partners must agree to use highly effective birth control throughout the duration of the study and for 90 days after stopping study drug. Patients who are using hormonal contraceptives or intrauterine devices should be instructed to use an additional contraceptive measure during the study such as a male or female condom with spermicide or diaphragm. Highly effective is defined as birth control methods that result in a failure rate of <1% per year when used consistently and correctly.
    E.4Principal exclusion criteria
    1. Is an employee of a clinical research organization, vendor, or Sponsor involved with this study
    2. Has known non-NASH liver disease, including, but not limited to, alcoholic liver disease, autoimmune disease, human immunodeficiency virus, hepatitis B virus, active hepatitis C virus (HCV), Wilson's disease, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, drug-induced liver injury, bile duct obstruction, or suspected or known liver cancer
    3. Has history of cirrhosis or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices
    4. Has known history of alcohol abuse or daily heavy alcohol consumption. Has an Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score of >=3 points for men and women AND a full Alcohol Use Disorders Identification Test (AUDIT) score of >=8 points at screening
    5. Has Gilbert's syndrome with direct bilirubin >1x ULN
    6. Is pregnant or breastfeeding
    7. Has clinically relevant immunosuppression, including, but not limited to, immunodeficiency conditions
    8. Has a known preexisting medical or psychiatric condition that could interfere with the patient's ability to provide informed consent or participate in study conduct, or that may confound study findings
    9. Has, in the opinion of the Investigator, clinically significant cardiovascular or cerebrovascular disease within 90 days prior to the first study drug administration
    10. Has participated in any drug study within 90 days prior to the first study drug administration in the current study
    11. Has had major surgery within 90 days prior to the first study drug administration in the current study
    12. Has a history of relevant drug and/or food allergies
    13. Has a history of hypersensitivity to the study drug or any of the
    excipients or placebo
    14. Unable to undergo an MRI PDFF due to:
    a. Contraindication to MRI examination
    b. Severe claustrophobia impacting ability to perform MRI during the study, despite mild sedation/treatment with a short half life (ie, <20
    hours) anxiolytic
    c. Body weight or girth exceeding the scanner capacities
    15. Is using any of the following disallowed medications:
    a. Anticancer drug(s), immunomodulator(s), or immunosuppressant(s) within 90 days or 5 half lives prior to screening, whichever is longer, or
    any drug historically associated with NAFLD with known liver toxicity for >2 weeks in the year prior to screening
    b. Vitamin E (>400 IU/day), glitazones, glucagon-like peptide 1 receptor agonists, ursodeoxycholic acid, or obeticholic acid within 90 days prior
    to screening
    c. Agents (including herbal over-the-counter weight loss preparations) or medications known to significantly impact body weight within 90 days
    prior to screening
    d. Statins other than rosuvastatin, atorvastatin, simvastatin, pravastatin, fluvastatin, or lovastatin
    e. Agents that are substrates for cytochrome P450 (CYP) 2C8 or CYP2C9 and have a narrow therapeutic index
    16. Has prior or planned (during the study period) bariatric surgery
    17. Has type 1 diabetes mellitus
    18. Has type 2 diabetes mellitus and hemoglobin A1c >9.5% or has not been on a stable dose of antidiabetic medication for at least 90 days
    prior to screening
    19. Has had total body weight loss of >5% within 6 months or since a liver biopsy, if applicable
    20. Has any of the following exclusionary laboratory results at screening:
    a. ALT >5x ULN, AST >5x ULN
    b. International normalized ratio >=1.3, unless on anticoagulant therapy
    c. Platelet count <lower limit of normal
    d. Estimated glomerular filtration rate <60 mL/min/1.73 m2 (the Modification of Diet in Renal Disease formula)
    e. Creatine kinase (CK) >ULN in patients on concomitant statin therapy and CK >3x ULN in all other patients
    f. Thyroid stimulating hormone >1.5x ULN or abnormal free triiodothyronine or free thyroxine
    21. Has history of clinically significant gastrointestinal disease
    (especially: cholecystectomy prior to age 25 years, peptic ulcerations,
    gastrointestinal bleeding, inflammatory bowel disease, or bariatric
    surgery); renal, hematologic, endocrine, oncologic, pulmonary,
    immunologic, or cardiovascular disease; neurologic or psychiatric
    disease (including any use of addictive substances such as regular opioid
    treatment and/or any use of illicit drugs); or any other condition, which,
    in the opinion of the Investigator, would jeopardize the safety of the
    patient or impact the validity of the study results.
    22. Has a body mass index >45 kg/m2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the efficacy of EYP001a, being the absolute change in Liver Fat Content as measured by MRI-PDFF from baseline to Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline to Week 12
    E.5.2Secondary end point(s)
    Efficacy:
    • Proportion of patients with >=5% absolute reduction in LFC as measured by MRI-PDFF from baseline to Week 12
    • Proportion of patients with >=10% absolute reduction in LFC as measured by MRI PDFF at Week 12
    • Proportion of patients with >=20% absolute reduction in LFC as measured by MRI PDFF at Week 12
    • Proportion of patients with a relative reduction in LFC >=20% as measured by MRI PDFF at Week 12
    • Proportion of patients with a relative reduction in LFC >=30% as measured by MRI PDFF at Week 12
    • Percent change (relative reduction) in LFC as measured by MRI-PDFF from baseline to Week 12
    • Change and percent change in imaging-derived mean cT1 from baseline to Week 12
    • Change and percent change in waist to hip ratio from baseline to Week 12 (Part B only)
    • Change and percent change in waist to height ratio from baseline to Week 12 (Part B only)
    • Change in the following biomarkers of liver fibrosis and inflammation: ALT, AST, AST/ALT ratio, adiponectin, high sensitivity C-reactive protein, interleukin 6, tumor necrosis factor alpha, cytokeratin-18, fibronectin, hyaluronic acid, procollagen type III N-terminal peptide, tissue inhibitor of metalloproteinases-1 (and derived enhanced liver fibrosis score), Pro C3, and chitinase 3 like protein 1 (also known as YKL-40) from baseline to Week 4, Week 8, and Week 14/ET, as applicable

    Pharmacokinetic (EYP001a concentrations) and Pharmacodynamic (C4 and FGF19 concentrations)

    Safety and tolerability : monitoring of adverse events, AESIs (ie, pruritus, [Part A only], drug induced liver injury, [Part A only], elevation of transaminases [Part B only], and all muscle related adverse events) and SAEs, and findings from physical examinations, vital signs, ECGs, and clinical laboratory parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: From baseline to Week 12

    PK:
    Part A: Day 1, Day 14 at 0 (predose), 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose, End of Study (EOS) and Early Termination (ET) Visits.
    Part B: predose and 2 hours postdose at : Days 1, 14, 28, 56, 84, EOS and ET Visits.

    PD:
    Part A: Day 1 and Day 14 at: 0 (predose), 4, 6, 10, 12, and 24 hours postdose, at the EOS and ET Visit . Sparse PD sampling will also occur predose and 2 hours postdose at Days 28, 56, and 84.
    Part B: predose and 2 hours postdose at Days 1, 14, 28, 56, and 84, EOS and ET Visits.

    Safety: throughout the study
    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 Yes
    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 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.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Puerto Rico
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days9
    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.1.2.1Number of subjects for this age range: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 114
    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 Decision2019-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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