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    Summary
    EudraCT Number:2020-004373-50
    Sponsor's Protocol Code Number:369852
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004373-50
    A.3Full title of the trial
    Effect of treatment with Semaglutide on cognitive function, neuroinflammation and hepatic nitrogen metabolism in patients with non-alcoholic steatohepatitis: A randomized placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of treatment with Semaglutide on cognitive function, brain inflammation and nitrogen-conversion in the liver in patients with non-alcoholic steatohepatitis: A randomized placebo-controlled trial
    A.4.1Sponsor's protocol code number369852
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Foundation of Manufacturer Vilhelm Pedersen and Wife
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointKristoffer Kjærgaard
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99, C117
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number4550906217
    B.5.6E-mailkrikje@clin.au.dk
    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 nameSemaglutide B 3.0 mg/ml PDS290
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.3Other descriptive nameSEMAGLUTIDE
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    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
    Non-alkoholisk steatohepatitis
    E.1.1.1Medical condition in easily understood language
    Non-alcoholic fatty liver disease
    Non-alkoholisk fedtleversygdom
    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 investigate the effect of treatment with Semaglutide on cognitive function in patients with non-alcoholic steatohepatitis.
    At undersøge effekten af behandling med Semaglutid på kognitiv funktion hos patienter med non-alkoholisk steatohepatitis.
    E.2.2Secondary objectives of the trial
    To investigate how treatment with Semaglutide affects known factors involved in cognitive problems in patients with liver disease, here brain inflammation and impaired nitrogen conversion in the liver.
    At undersøge hvordan behandling med Semaglutid påvirker kendte faktorer involveret i kognitive problemer hos patienter med leversygdom, herunder inflammation i hjernen og nedsat nitrogen-omsætning i leveren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 - 69 years.
    2. Biopsy-proven NASH
    3. Understands and speaks Danish
    4. Alcohol consumption < 40g/day
    5. Exclusion of other liver pathology
    1. Alder 18 - 69 år
    2. Forstår og taler dansk
    3. Klinisk mistanke om NASH (steatose sammen med metabolisk syndrom og/eller forhøjede transaminaser (40))
    4. Alkoholindtag < 40g/dag (sv.t. 3.5 DK genstande)
    5. Udelukkelse af anden leverpatologi
    E.4Principal exclusion criteria
    1. Known chronic inflammatory disease
    2. Contraindication for liver biopsy: Anamnestic, clinical or laboratory signs of hemorrhagic diatesis, infection at the insertion area or focal changes in the liver
    3. Diabetes Mellitus type 1 or 2 (HbA1c > 48 mmol/mol)
    4. Bacterial infection
    5. Known cancer
    6. Known neurolodegenerative disease
    7. Known severe impairment of hearing or eye sight
    8. Known allergy towards one or more ingredients in the Ozempic® formula
    9. Treatment with antipsychotics or other psychotropic drugs with sedative effects
    10. Treatment with corticosteroids within the past 8 weeks
    11. Breastfeeding
    12. Pregnancy demonstrated by a positive pregnancy test or desire to become pregnant and no use of safe anti-conception (p-pills, intrauterine device, sterilised)
    1. Kendt kronisk inflammatorisk sygdom
    2. Kontraindikation for leverbiopsi: Anamnestiske, kliniske eller laboratoriemæssige tegn på hæmoragisk diatese, infektion i indstiksområdet eller fokale forandringer i leveren
    3. Diabetes mellitus type 1 eller 2 (HbA1c > 48 mmol/mol)
    4. Bakteriel infektion (sepsis, pneumoni, urinvejsinfektion mv.)
    5. Kendt cancersygdom
    6. Kendt neurodegenerativ sygdom
    7. Kendt svær syns- eller hørenedsættelse
    8. Kendt allergi over for et eller flere af indholdsstofferne i Semaglutid
    9. Behandling med antipsykotika og anden psykofarmaka med sederende virkning
    10. Behandling med kortikosteroider inden for de sidste 8 uger
    11. Amning
    12. Graviditet påvist ved positiv graviditetstest el. ønske om at blive gravid og manglende anvendelse af sikker anti-konception (p-piller, intrauterin device, steriliseret)
    E.5 End points
    E.5.1Primary end point(s)
    Change in cognitive function assessed by the Portosystemic Encephalopathy (PSE) test – measured as Portosystemic Hepatic Encephalopathy Score (PHES).
    Ændring i samlet kognitiv funktion vurderet ved Portosystemic Encephalopathy (PSE) test – målt som Portosystemic Hepatic Encephalopathy Score (PHES).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months (28 weeks).
    6 måneder (28 uger).
    E.5.2Secondary end point(s)
    • Change in attention and psychomotor speed assessed by continuous reaction time (CRT) – measured as Index score.
    • Change in function of separate cognitive domains assessed by a neuropsychological test battery – measured as test scores in individual neuropsychological tests.
    • Change in neuroinflammation assessed by PET/MRI of the brain – measured as 11C-PK11195 binding potential in brain regions.
    • Change in systemic inflammation assessed by levels of proinflammatory cytokines in blood.
    • Change in hepatic urea synthesis function assessed by the Functional Hepatic Nitrogen Clearance (FHNC) method – measured as FHNC.
    • Change in NASH severity assessed by histological examination of tissue from liver biopsy – measured as NAS-score and Kleiner fibrosis grade.
    • Ændring i opmærksomhedsfunktion vurderet ved reaktionstidsmåling – målt som Index score, CRT.
    • Ændring i funktion af enkelte kognitive domæner vurderet ved neuropsykologisk testbatteri – målt som testscore i individuelle neuropsykologiske tests.
    • Ændring i hjernens funktionelle konnektivitet vurderet ved EEG og SEP – målt som phase-lag index.
    • Ændring i niveau af systemisk inflammation vurderet ved mængde af proinflammatoriske cytokiner i blodet – målt som koncentration af cytokiner i venøs blodprøve.
    • Ændring i neuroinflammation vurderet ved PET/MR skanning af hjernen – målt som 11C-PK11195 aktivitet på PET billederne.
    • Ændring i urinstofsyntesefunktion i leveren vurderet ved Functional Hepatic Nitrogen Clearance (FHNC) metoden – målt som FHNC.
    • Ændring i NASH sværhedsgrad vurderet ved histologisk undersøgelse af væv fra leverbiopsi – målt som NAS-score og fibrosegrad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month (4 weeks) and 6 months (28 weeks).
    1 måned (4 uger) og 6 måneder (28 uger).
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 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 or 1. of July 2030 at the latest.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state24
    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 Decision2021-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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