Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-003566-39
    Sponsor's Protocol Code Number:NN9500-4656
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003566-39
    A.3Full title of the trial
    Efficacy and safety investigation of NNC0194-0499 co-administered with
    semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging,
    placebo-controlled trial
    Studio di efficacia e sicurezza di NNC0194-0499 somministrato in combinazione con semaglutide in soggetti con steatoepatite non alcolica: sperimentazione dose-ranging, controllata verso placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study on whether a combination of 2 medicines (NNC0194-0499
    and semaglutide) works in people with non-alcoholic steatohepatitis
    (NASH)
    Studio clinico che valuta gli effetti di una combinazione di 2 medicinali (NNC0194-0499 e semaglutide) in persone affette da steatoepatite non alcolica (NASH).
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberNN9500-4656
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1255-5551
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Transparency (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 nameNNC0174-0833 A 10 mg/mL
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB90530
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 nameNNC0194-0499 B 50 mg/mL
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB185034 D.3.9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    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 nameSemaglutide B 3 mg/mL PDS290
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNSEMAGLUTIDE
    D.3.9.1CAS number 910463-68-2
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    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 pen
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in cartridge
    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
    Non-alcoholic steatohepatitis
    Steatoepatite non alcolica
    E.1.1.1Medical condition in easily understood language
    Non-alcoholic steatohepatitis (NASH)
    Steatoepatite non alcolica (NASH)
    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 confirm the effect of NNC0194-0499 30 mg once weekly in combination with semaglutide 2.4 mg once weekly versus placebo once weekly on fibrosis in subjects with NASH and fibrosis stage 2-4 (F2- F4).
    Confermare gli effetti di NNC0194-0499 30 mg una volta alla settimana in combinazione con semaglutide 2,4 mg una volta alla settimana rispetto al placebo una volta settimanalmente su fibrosi in soggetti con NASH e stadio di fibrosi 2-4 (F2-F4).
    E.2.2Secondary objectives of the trial
    In subjects with NASH and F2-F4:
    • To investigate the dose-response relationship of NNC0194-0499 (7.5 mg, 15 mg and 30 mg) once weekly in combination with semaglutide 2.4 mg once weekly on liver histology and tolerability.
    • To investigate the safety and tolerability of NNC0194-0499 30 mg once weekly alone, NC0194-0499 7.5 mg, 15 mg and 30 mg once weekly in combination with semaglutide 2.4 mg once weekly and NNC0174-0833 2.4 mg once weekly in combination with semaglutide 2.4 mg once weekly.
    Nei soggetti con NASH e F2 - F4:
    • indagare la relazione dose-risposta di NNC0194-0499 (7.5 mg, 15 mg e 30 mg) una volta alla settimana in combinazione con semaglutide 2.4 mg una volta alla settimana sull'istologia epatica e sulla tollerabilità.
    • Indagare la sicurezza e la tollerabilità di 1) NNC0194-0499 30 mg una volta alla settimana, 2) di NNC0194-0499 7,5 mg, 15 mg e 30 mg una volta alla settimana in combinazione con semaglutide 2,4 mg una volta alla settimana e 3) di NNC0174-0833 2,4 mg una volta alla settimana in combinazione con semaglutide 2,4 mg una volta alla settimana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged greater than or equal to 18 years at the time of signing informed consent.
    - Histological evidence of non-alcoholic steatohepatitis (NASH) based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to visit 1.
    - Histological evidence of fibrosis stage 2, 3 or 4 according to the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) classification based on a central pathologist evaluation of the baseline liver biopsy.
    - Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greater than or equal to 4 for subjects with F2/F3 or greater than or equal to 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.
    - Età superiore o uguale a 18 anni al momento della firma del consenso informato.
    - Evidenza istologica di steatoepatite non alcolica (NASH) basata sulla valutazione della biopsia basale da parte del patologo centrale. La biopsia epatica basale può essere una biopsia storica ottenuta entro 180 giorni prima della visita 1.
    - Evidenza istologica di fibrosi di grado 2, 3 o 4 secondo la classificazione NASH CRN (Nonalcoholic Steatoepatitis Clinical Research Network) basata sulla valutazione della biopsia epatica basale da parte del patologo centrale.
    - Punteggio istologico di attività della steatosi epatica non-alcolica (non-alcoholic fatty liver disease - NAFLD) (NAFLD activity score - NAS) maggiore o uguale a 4 per soggetti con F2 / F3 o maggiore o uguale a 3 per soggetti con F4 sulla base della valutazione della biopsia epatica basale da parte del patologo centrale. Tutti i soggetti devono avere un punteggio di 1 o più in steatosi, infiammazione lobulare e ballooning degli epatociti.
    E.4Principal exclusion criteria
    - Documented causes of chronic liver disease other than NAFLD.
    - Positive Hepatitis B surface antigen (HBsAg), positive anti-human immunodeficiency virus (HIV), positive hepatitis C virus ribonucleic acid (HCV RNA) at screening visit 2A (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
    - Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.
    - Presence or history of gastro-oesophageal varices greater than or equal to grade 2 at V2A. For subjects with F4, an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be available at V2A.
    - Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
    - Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
    - Treatment with glucagon-like peptide-1 receptor agonist (GLP-1 RAs) within 90 days prior to V2A. Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until V2A.
    - Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
    - Cause documentate di malattia epatica cronica diverse dalla NAFLD.
    - Positività all'antigene di superficie dell'epatite B (HBsAg), positività al virus dell'immunodeficienza umana (HIV), positività all'acido ribonucleico del virus dell'epatite C (HCV RNA) alla visita di screening 2A (V2A) o qualsiasi presenza nota di HCV RNA o HBsAg entro 2 anni dalla visita di screening (V2A).
    - Presenza o anamnesi di ascite superiore al grado 1, sanguinamento da varici, encefalopatia epatica, peritonite batterica spontanea o trapianto di fegato alla visita di screening V2A.
    - Presenza o anamnesi di varici gastro-esofagee di grado maggiore o uguale a 2 alla visita di screening V2A. Per i soggetti con F4, deve essere disponibile alla V2A un'esofagogastroduodenoscopia eseguita non più di 52 settimane prima della V2A.
    - Noto o sospetto consumo eccessivo di alcol (superiore a 20 g/giorno per le donne o superiore a 30 g/giorno per gli uomini) o dipendenza da alcol (valutata utilizzando il test di identificazione dei disturbi da uso di alcol (questionario AUDIT))
    - Trattamento con vitamina E (a dosi maggiori o uguali a 800 UI/die) o pioglitazone o farmaci approvati per il trattamento della NASH che non siano ad una dose stabile secondo l'opinione dello sperimentatore nei 90 giorni prima della visita di screening V2A. Inoltre, per i soggetti con una biopsia epatica storica eseguita più di 90 giorni prima della V2A, il trattamento deve essere a una dose stabile secondo l'opinione dello sperimentatore dal momento della biopsia fino alla V2A.
    - Trattamento con agonisti del recettore del peptide-1 simile al glucagone (GLP-1 RA) entro 90 giorni prima della V2A. Inoltre, per i soggetti con una biopsia epatica storica eseguita più di 90 giorni prima della V2A il trattamento con GLP-1 RA non deve essere stato ricevuto dal momento della biopsia fino al V2A.
    - Trattamento con uno o più agenti ipoglicemizzanti (diversi dai GLP-1 RA), farmaci ipolipemizzanti o farmaci per la perdita di peso che non siano ad una dose stabile secondo l'opinione dello sperimentatore nei 90 giorni prima della V2A. Inoltre, per i soggetti con una biopsia epatica storica eseguita più di 90 giorni prima della V2A, il trattamento deve essere a una dose stabile secondo l'opinione dello sperimentatore dal momento della biopsia fino alla V2A.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in liver fibrosis and no worsening of NASH (Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale. No worsening of NASH is defined as no increase from baseline in NAS score for ballooning, inflammation or steatosis.) (Yes/No).
    Miglioramento della fibrosi epatica e nessun peggioramento della NASH (il miglioramento della fibrosi è definito come un miglioramento di 1 grado o più sulla scala di fibrosi NASH CRN. Nessun peggioramento della NASH è definito come nessun aumento rispetto al basale del punteggio NAS per ballooning, infiammazione o steatosi degli epatociti.) (Sì / No).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (week 0) to week 52.
    Dal baseline (settimana 0) alla settimana 52.
    E.5.2Secondary end point(s)
    1. Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
    2. Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
    3. Change in histology-assessed liver collagen proportionate area
    4. Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
    5. Improvement in liver fibrosis (Yes/No)
    6. Progression of liver fibrosis (Yes/No)
    7. Worsening in steatohepatitis (Yes/No)
    8. Improvement in ballooning (Yes/No)
    9. Improvement in inflammation (Yes/No)
    10. Improvement in steatosis (Yes/No)
    11. Change in ALT (alanine aminotransferase)
    12. Change in AST (aspartate aminotransferase)
    13. Change in inflammation assessed by HsCRP (high sensitivity Creactive protein)
    14. Change in (Enhanced Liver Fibrosis) ELF score
    15. Change in (glycated haemoglobin) HbA1c
    16. Change in triglycerides
    17. Change in free fatty acids
    18. Change in low density lipoprotein (LDL) cholesterol
    19. Change in high density lipoprotein (HDL) cholesterol
    20. Relative change in body weight
    21. Change in (36-item Short Form Survey) SF-36 bodily pain
    22. Change in Patient reported outcome measure for non-alcoholic steatohepatitis (NASH-CHECK) pain
    23. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score
    24. Number of treatment emergent adverse events (TEAEs)
    1. Risoluzione della steatoepatite e nessun peggioramento della fibrosi epatica (Sì / No)
    2. Miglioramento della steatoepatite con una riduzione di almeno 2 punti nello score NAS e nessun peggioramento della fibrosi (Sì / No).
    3. Modifica dell'area proporzionale al collagene epatico valutata dall'istologia
    4. Risoluzione della steatoepatite e miglioramento della fibrosi epatica (Sì / No)
    5. Miglioramento della fibrosi epatica (Sì / No)
    6. Progressione della fibrosi epatica (Sì / No)
    7. Peggioramento della steatoepatite (Sì / No)
    8. Miglioramento del ballooning (Sì / No)
    9. Miglioramento dell'infiammazione (Sì / No)
    10. Miglioramento della steatosi (Sì / No)
    11. Variazione di ALT (alanina aminotransferasi)
    12. Variazione di AST (aspartato aminotransferasi)
    13. Variazione dell'infiammazione valutate in base ai livelli di HsCRP (proteina C- reattiva ad alta sensibilità)
    14. Variazione del punteggio ELF (Enhanced Liver Fibrosis)
    15. Variazione di HbA1c (emoglobina glicata)
    16. Variazione dei trigliceridi
    17. Variazione degli acidi grassi liberi
    18. Variazione del colesterolo LDL (lipoproteine ¿¿a bassa densità)
    19. Variazione del colesterolo HDL (lipoproteine ¿¿ad alta densità)
    20. Variazione relativa del peso corporeo
    21. Variazione nel SF-36 (36-item Short Form Survey) sul dolore corporeo
    22. Variazione nel questionario per il dolore da steatoepatite non alcolica (NASH-CHECK)
    23. Variazione nel questionario sul punteggio della fatica PROMIS (Patient-Reported Outcomes Measurement Information System)
    24. Numero di eventi avversi emergenti dal trattamento (TEAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-23. From baseline (week 0) to week 52
    24. From baseline (week 0) to week 59
    1-23: dal baseline (settimana 0) alla settimana 52.
    24: dal baseline (settimana 0) alla settimana 59.
    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 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
    Tolerability
    Tollerabilità
    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 trial10
    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 EEA55
    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
    Australia
    Canada
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Russian Federation
    Singapore
    United States
    European Union
    United Kingdom
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days13
    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: 504
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 672
    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
    nessuno
    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 Decision2021-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-29
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 20:51:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA