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    Summary
    EudraCT Number:2019-001550-26
    Sponsor's Protocol Code Number:I8F-MC-GPHR
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-21
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001550-26
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing
    the Efficacy and Safety of Tirzepatide versus Placebo in Patients with
    Nonalcoholic Steatohepatitis (NASH)
    Estudio de fase 2, aleatorizado, con enmascaramiento doble, en el que se comparan la eficacia y la seguridad de tirzepatida con las de un placebo en pacientes con esteatohepatitis no alcohólica (EHNA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tirzepatide versus placebo in NASH
    Comparación de tirzepatida frente a un placebo en la EHNA
    A.3.2Name or abbreviated title of the trial where available
    SYNERGY-NASH
    SYNERGY-EHNA
    A.4.1Sponsor's protocol code numberI8F-MC-GPHR
    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 SponsorLilly S.A
    B.1.3.4CountrySpain
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly Cork Ltd
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, Eastgate Road, Eastgate Business Oark, Little Island
    B.5.3.2Town/ cityCo.Cork
    B.5.3.3Post codeT45KD39
    B.5.3.4CountryIreland
    B.5.6E-mailensayosclinicos@lilly.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 nameLY3298176 Injection
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirzepatide
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 nameLY3298176 Injection
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirzepatide
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    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 nameLY3298176 Injection
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirzepatide
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 4
    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 nameLY3298176 Injection
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirzepatide
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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.IMP: 5
    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 nameLY3298176 Injection
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirzepatide
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 6
    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 nameLY3298176 Injection
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirzepatide
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nonalcoholic Steatohepatitis (NASH)
    Esteatohepatitis no alcohólica (EHNA)
    E.1.1.1Medical condition in easily understood language
    Nonalcoholic Steatohepatitis (NASH)
    Esteatohepatitis no alcohólica (EHNA)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    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 demonstrate that Tirzepatide 5mg, 10mg or 15mg administered SC QW is superior to placebo for NASH resolution with no worsening of fibrosis at Week 52.
    Demostrar que tirzepatida 5 mg, 10 mg o 15 mg administrado por vía s.c. 1 v/s es superior al placebo desde el punto de vista de la resolución de la EHNA sin empeoramiento de la fibrosis en la semana 52.
    E.2.2Secondary objectives of the trial
    To demonstrate that Tirzepatide 5mg, 10mg or 15mg administered SC QW is superior to placebo at Week 52 for :
    - Regression of fibrosis with no worsening of NASH
    - Prevention of fibrosis progression
    - Decreasing NAS by ≥ 2 points
    - Decreasing liver fat content
    - Decreasing body weight
    Demostrar que tirzepatida 5 mg, 10 mg o 15 mg administrado por vía s.c. 1 v/s es superior al placebo en la semana 52 desde el punto de vista de:
    - La regresión de la fibrosis sin empeoramiento de la EHNA
    - La prevención de la progresión de la fibrosis
    - Una disminución ≥ 2 puntos en la NAS
    - La disminución de la cantidad de grasa hepática
    - La pérdida de peso
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum I8F-MC-GPHR (1.2) 25 Oct 2019 : A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (SYNERGY-NASH).
    The primary objective of this addendum is to demonstrate that tirzepatide administered SC QW is superior to placebo for the mean change from baseline in liver stiffness as measured by 2-dimensional MRE at 52 weeks in patients with NASH.
    Adenda al protocolo I8F-MC-GPHR (1.2) de 25 de octubre de 2019: Estudio de fase 2, aleatorizado, con enmascaramiento doble, en el que se comparan la eficacia y la seguridad de tirzepatida con las de un placebo en pacientes con esteatohepatitis no alcohólica (SYNERGY-NASH)
    El objetivo principal de esta adenda es demostrar que tirzepatida, administrado por vía s.c. 1 v/s, es superior al placebo en la semana 52 en relación con la media de la variación respecto al período inicial en la rigidez hepática, de acuerdo con los resultados de una ERM bidimensional, en pacientes con EHNA.
    E.3Principal inclusion criteria
    - Female or male 18 to 80 years of age (inclusive)
    - Body Mass Index (BMI) ≥ 27kg/m² and ≤50 kg/m2
    - Participants with T2DM (HbA1c ≤ 9.5% at screening, treated with diet and/or exercice, or treated with oral antihyperglycemic medication (as detailed in the protocol))
    - Participants without diagnosed T2DM (HbA1c < 6.5% at screening and fasting glucose < 7.0 mmol/L)
    - Diagnosis of NASH by liver biopsy
    - NAFLD Activity Score (NAS) ≥ 4 with ≥ 1 point for each component
    - Fibrosis stage 2 or 3 according to the NASH CRN scoring system
    - Stable body weight for at least 3 months. For participants entering the study with a liver biopsy done between 3 to 6 months from the screening visit, body weight must be stable (<5% body weight change) for the period of time between the biopsy and the screening visit.
    - Pacientes de ambos sexos, de entre 18 y 80 años (ambos incluidos).
    - Índice de masa corporal (IMC) ≥ 27kg/m² y ≤50 kg/m2
    - Participantes con DMT2 (HbA1c ≤ 9,5 % durante la selección; tratada con dieta o ejercicio, o con antihiperglucemiantes orales [según se detalla en el protocolo]).
    - Participantes a los que no se les haya diagnosticado DMT2 (HbA1c < 6,5 % durante la selección y glucosa en ayunas < 7,0 mmol/l).
    - Diagnóstico de EHNA de acuerdo con los resultados de una biopsia hepática.
    - Puntuación de la actividad de la EHNA (NAS) ≥ 4 con ≥ 1 punto para cada componente.
    - Fibrosis en estadio 2 o 3 de acuerdo con el sistema de puntuación de la NASH CRN.
    - Peso corporal estable al menos durante 3 meses. En relación con los participantes a los que se les hubiera realizado una biopsia hepática entre 3 y 6 meses antes de la visita de selección, deben presentar un peso estable (es decir, una variación en el peso corporal inferior al 5 %) en el período comprendido entre dicha biopsia y la visita de selección.
    E.4Principal exclusion criteria
    - Alcohol consumption > 14 units/week for women and > 21 units/week for men
    - Fibrosis stages 0 and 1 according to the NASH CRN scoring system
    - Cirrhosis (fibrosis stage 4)
    - Platelet count < 150,000/mm3
    - Evidence of other forms of chronic liver disease
    - Uncontrolled T2DM
    - Consumo de alcohol > 14 unidades/semana (mujeres) y > 21 unidades/semana (varones).
    - Fibrosis en estadio 0 o 1 de acuerdo con el sistema de puntuación de la NASH CRN.
    - Cirrosis (fibrosis en estadio 4).
    - Cifra de plaquetas < 150,000/mm3
    - Signos de otros tipos de hepatopatías crónicas.
    - DMT2 sin controlar.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants classified with absence of NASH with no worsening of fibrosis on liver histology
    Proporción de participantes que se considere que no presentan EHNA ni tampoco empeoramiento de la fibrosis, de acuerdo con las características histológicas del hígado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    E.5.2Secondary end point(s)
    From baseline :
    - Proportion of participants with ≥1 point decrease in fibrosis stage with no worsening of NASH on liver histology
    - Proportion of participants with ≥1 point increase in fibrosis stage on liver histology
    - Proportion of participants that achieve a ≥2 point decrease in NAS on liver histology, with ≥1 point reduction in at least 2 NAS components (steatosis, hepatocellular ballooning, lobular inflammation)
    - Mean absolute change in liver fat content by MRI-PDFF
    - Mean change in body weight
    Respecto al período inicial:
    - Proporción de participantes con una disminución ≥1 punto en el estadio de la fibrosis, sin empeoramiento de la EHNA, de acuerdo con las características histológicas del hígado.
    - Proporción de participantes con un aumento ≥1 punto en el estadio de la fibrosis, de acuerdo con las características histológicas del hígado.
    - Proporción de participantes que presenten una disminución ≥2 puntos en la NAS, de acuerdo con las características histológicas del hígado, y una disminución ≥1 punto al menos en 2 componentes de la NAS (esteatosis, degeneración vacuolar hepática, inflamación lobular).
    - Media de la variación absoluta en la cantidad de grasa hepática de acuerdo con los resultados de una RMN-DPFG.
    - Media de la variación en el peso corporal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Israel
    Italy
    Japan
    Mexico
    Spain
    United Kingdom
    United States
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 196
    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)
    There are not any approved medications for the treatment of Nonalcoholic Steatohepatitis (NASH). Patients will continue diet and physical exercise after the final study GPHR and associated procedures have been completed.
    En la actualidad no existe ningún medicamento aprobado para el tratamiento de la esteatohepatitis no alcohólica (EHNA). Una vez que el estudio GPHR y los procedimientos relacionados finalicen, los pacientes continuarán su dieta y realizando el grado de ejercicio habituales.
    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 Decision2020-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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