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    Summary
    EudraCT Number:2021-006677-26
    Sponsor's Protocol Code Number:68797373
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-04-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-006677-26
    A.3Full title of the trial
    Metabolic effects of ketohexokinase inhibition in individuals with non-alcoholic fatty liver disease
    Metabole effecten van een ketohexokinase remmer in personen met niet-alcoholische leververvetting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metabolic effects of inhibition of fructose metabolism in individuals with a fatty liver
    Metabole effecten van remming van fructose metabolisme in personen met een vette lever
    A.3.2Name or abbreviated title of the trial where available
    KHKi in NAFLD
    KHK-remming in NAFLD
    A.4.1Sponsor's protocol code number68797373
    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 SponsorMaastricht University
    B.1.3.4CountryNetherlands
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointNutrition and Movement Sciences
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 50
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6200MD
    B.5.3.4CountryNetherlands
    B.5.6E-maile.koene@maastrichtuniversity.nl
    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 namePF-06835919
    D.3.2Product code PF-06835919
    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 INNPF-06835919
    D.3.9.2Current sponsor codePF-06835919
    D.3.9.3Other descriptive namePF-06835919
    D.3.9.4EV Substance CodeSUB203449
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Healthy volunteers (non-alcoholic fatty liver disease)
    Gezonde deelnemers (niet-alcoholische leververvetting)
    E.1.1.1Medical condition in easily understood language
    Fatty liver
    Vette lever
    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 25.0
    E.1.2Level PT
    E.1.2Classification code 10029530
    E.1.2Term Non-alcoholic fatty liver
    E.1.2System Organ Class 10024581 - Lipid metabolism and deposit disorders NEC
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.0
    E.1.2Level LLT
    E.1.2Classification code 10082249
    E.1.2Term Nonalcoholic fatty liver disease
    E.1.2System Organ Class 10024581 - Lipid metabolism and deposit disorders NEC
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determining the effect of the ketohexokinase inhibitor, PF-06835919, on hepatic insulin sensitivity in individuals with non-alcoholic fatty liver disease.
    Het bepalen van het effect van de ketohexokinase remmer, PF-06835919, op lever insulinegevoeligheid in mensen met niet-alcoholische leververvetting.
    E.2.2Secondary objectives of the trial
    -Determining the effect of the ketohexokinase inhibitor, PF-06835919, on fat distribution and adipose tissue function.
    -Determining the in vivo activity of ketohexokinase, gut microbiota composition and alternative metabolic pathways of fructose after treatment with PF-06835919.
    -Het bepalen van het effect van de ketohexokinase remmer, PF-06835919, op vetdistributie en vetweefselfunctie.
    -Het bepalen van in vivo activiteit van ketohexokinase, darmmicrobiota compositie en alternatieve metabolisatie wegen van fructose na behandeling met PF-06835919.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Men and (postmenopausal) woman
    -Age: ≥ 40 and ≤ 75 years
    -BMI: 27-38 kg/m2
    -Hepatic steatosis (i.e. IHL content ≥ 5.56%)
    -Stable dietary habits (no weight loss or gain >3 kg in the 3 months prior to inclusion)
    -Participants are able to provide signed and dated written informed consent prior to any study specific procedures
    -Mannen en postmenopauzale vrouwen
    -Leeftijd ≥ 40 en ≤ 75 jaar
    -BMI: 27-38 kg/m2
    -Leververvetting (i.e. levervetgehalte ≥ 5.56%)
    -Stabiele eetgewoontes (geen gewichtstoename of gewichtsafname >3 kg in de 3 maanden voorafgaand aan deelname)
    -Deelnemers zijn in staat om ondertekende en gedateerde geschreven geïnformeerde toestemming te verschaffen voorafgaand enige studie specifieke procedures
    E.4Principal exclusion criteria
    -Type 2 diabetes
    -Any contra-indication for MRI scanning
    -Patients with congestive heart failure and and/or severe renal and/or liver insufficiency
    -Uncontrolled hypertension
    -Alcohol consumption of >3 servings per day for man and >2 servings per day for woman
    -Smoking
    -Unstable body weight (weight loss or gain >3 kg in the 3 months prior to inclusion)
    -Engagement in structured exercise activities > 2 hours a week
    -Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results
    -Use of drugs that inhibit organic anion transporting polypeptide (OATP) transporters (e.g. rifampicin, gemfibrozil, cyclosporine, erythromcyin and clarithromycin)
    -Subjects who do not want to be informed about unexpected medical findings
    -Type 2 diabetes
    -Elke contra-indicatie voor MRI scans
    -Patiënten met congestief hartfalen en/of ernstige nierfalen en/of leverfalen
    -ongecontroleerde hypertensie
    -Alcoholgebruik van >3 porties per dag voor mannen en >2 porties per dag voor vrouwen
    -Onstabiel lichaamsgewicht (gewichtstoename of gewichtsafname >3 kg in de 3 maanden voorafgaand aan deelname)
    -Uitoefenen van gestructureerde sportactiviteiten >2 uur per week
    -Deelname aan een klinische studie met een onderzoeksproduct in de voorafgaande 3 maanden, of als zodanig beoordeeld door de onderzoeker, die onze resultaten kan beïnvloeden
    -Medicatie gebruik dat organisch anion transporterend polypeptide (OATP) transporters blokkeert (e.g. gemfibrozil, cyclosporine, erythromcyin en clarithromycin)
    -Deelnemers die niet willen worden geïnformeerd over onverwachte medische bevindingen
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is hepatic insulin sensitivity, measured during the hyperinsulinemic euglycemic clamp as insulin-mediated suppression of endogenous glucose production, after 6 weeks of taking PF-06835919 compared to placebo.
    De primaire uitkomstmaat is leverinsulinegevoeligheid, gemeten tijdens de hyperinsulinaemisch euglycemische clamp als insuline-gemedieerde onderdrukking van endogene glucose productie, na 6 weken inname van PF-06835919 vergeleken met placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated after participants have taken PF-06835919 daily for six weeks, and after participants have taken the placebo daily for six weeks.
    De primaire uitkomstmaat zal worden beoordeeld nadat deelnemers PF-06835919 dagelijks voor zes weken hebben geconsumeerd, en nadat deelnemers de placebo dagelijks voor zes weken hebben geconsumeerd.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    -Intrahepatic lipid content measured during H-MRS
    -Liver lipid composition measured during H-MRS'
    -Amount of subcutaneous and visceral fat measured during MRI
    -Insulin-mediated suppression of free fatty acids measured in blood plasma taken during the hyperinsulinemic euglycemic clamp
    -Inflammatory markers measured in blood serum taken during the hyperinsulinemic euglycemic clamp
    -Resting energy expenditure measured by indirect calorimetry during the hyperinsulinemic euglycemic clamp
    -Sleep metabolic rate measure during the overnight stay in the respiration chamber
    -Body composition measured by the Bod Pod
    -Liver phosphomonoester levels as indication for ketohexokinase activity in the liver measured during P-MRS
    -Peripheral insulin sensitivity measured during the hyperinsulinemic euglycemic clamp
    -Metabolic flexibility measured during the hyperinsulinemic euglycemic clamp
    -Intramyocellular lipid content measured in the muscle biopsy
    -Short-chain fatty acids measured in fecal samples
    De secundaire uitkomstmaten zijn:
    -Hoeveelheid levervet gemeten tijdens H-MRS
    -Levervetcompositie gemeten tijdens H-MRS
    -Hoeveelheid subcutaan en visceraal vet gemeten tijdens MRI
    -Insuline-gemedieerde onderdrukking van vrije vetzuren gemeten in bloedplasma afgenomen tijdens de hyperinsulinaemisch euglycemische clamp
    -Ontstekingsmarkers gemeten in bloedserum afgenomen tijdens de hyperinsulinaemisch euglycemische clamp
    -Energieverbruik in rust gemeten door indirecte calorimetrie tijdens de hyperinsulinaemisch euglycemische clamp
    -Slaapstofwisseling gemeten tijdens overnachting in respiratiekamer
    -Lichaamssamenstelling gemeten door de Bod Pod
    -Phosphomonoesters in de lever als indicatie voor ketohexokinase activiteit in de lever gemeten tijdens P-MRS
    -Perifere insulinegevoeligheid gemeten tijdens de hyperinsulinaemisch euglycemische clamp
    -Metabolische flexibiliteit gemeten tijdens de hyperinsulinaemisch euglycemische clamp
    -Hoeveelheid intramusculair vet gemeten in het spierbiopt
    -Korte-keten vetzuren gemeten in ontlasting
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated after participants have taken PF-06835919 daily for six weeks, and after participants have taken the placebo daily for six weeks.
    De secundaire uitkomstmaten zullen worden beoordeeld nadat deelnemers PF-06835919 dagelijks voor zes weken hebben geconsumeerd, en nadat deelnemers de placebo dagelijks voor zes weken hebben geconsumeerd.
    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 No
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    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
    Geen
    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 Decision2022-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-24
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