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    Summary
    EudraCT Number:2021-001247-27
    Sponsor's Protocol Code Number:202100166
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-09
    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 number2021-001247-27
    A.3Full title of the trial
    SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes
    SeMaglutide en Albuminurie Reductie Trial in individuen met (ernstig) overgewicht zonder diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to study the effect of semaglutide on reducing urinary albumin excretion in people with serious overweight without diabetes.
    Onderzoek naar het effect van semaglutide op het verlagen van albumine uitscheiding in de urine bij mensen met (ernstig) overgewicht zonder diabetes.
    A.3.2Name or abbreviated title of the trial where available
    SMART
    A.4.1Sponsor's protocol code number202100166
    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 SponsorUniversity Medical Center Groningen
    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 supportNovo Nordisk
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone numberNeder0503617859
    B.5.6E-mailh.j.lambers.heerspink@umcg.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 namesemaglutide 3 mg/ml
    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.3.9.3Other descriptive nameSEMAGLUTIDE
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overweight and obese individuals at high risk of chronic kidney disease progression.
    Mensen met overgewicht en obesitas en een hoog risico op CKD progressie.
    E.1.1.1Medical condition in easily understood language
    Overweight and obese individuals at high risk of progression of chronic kidney damage.
    Mensen met overgewicht en ernstig overgewicht en een hoog risico op verergering van chronische nierschade.
    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 PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001580
    E.1.2Term Albuminuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria.
    Het hoofddoel van de studie is om de albuminurie-verlagende effecten van semaglutide 2,4 mg s.c. eenmaal per week (Semaglutide 3 mg/ml) ten opzichte van placebo vast te stellen bij niet-diabetische personen met obesitas/overgewicht en verhoogde albuminurie.
    E.2.2Secondary objectives of the trial
    Assess the effect of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) on:
    - eGFR (all patients)
    - Iohexol measured GFR (46 patients),
    - change in UACR and eGFR during wash-out from week 24 to 28
    - body weight and hip circumference
    - systolic/diastolic blood pressure
    - extracellular fluid using bio-impedance spectroscopy (Impedimed FP7)
    - high sensitivity CRP.
    Onderzoeken van het effect van semaglutide 2.4 mg s.c. 1x/week (Semaglutide 3 mg/ml) op:
    - eGFR (alle deelnemers),
    - Iohexol gemeten GFR (46 proefpersonen),
    - verandering in UACR en eGFR tijdens wash-out van week 24 tot 28
    - lichaamsgewicht
    - heupomtrek,
    - systolische / diastolische bloeddruk,
    - extracellulaire vloeistof,
    - zeer gevoelige CRP
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    GFR substudy:
    In 46 patients, GFR measurements by plasma clearance of non-radioactive iohexol will be performed at the start and end of the treatment period and after 4 weeks of wash-out from the study drug.
    Liver stiffness measurement:
    In a subgroup of patients liver stiffness and liver fat will be measured at baseline and week 24 using a non-invasive device, the fibroscan.
    GFR substudie:
    Bij 46 patiënten zullen GFR-metingen door plasmaklaring van niet-radioactief iohexol worden uitgevoerd aan het begin en het einde van de behandelingsperiode en na 4 weken wash-out van het onderzoeksgeneesmiddel.
    Meting van leverstijfheid:
    In een subgroep van patiënten zullen leverstijfheid en leververvetting worden gemeten bij aanvang en in week 24 met behulp van een niet-invasief apparaat, de fibroscan.
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Body Mass index ≥ 27 kg/m2
    • Albuminuria ≥ 30 mg/g and ≤ 3500 mg/g
    • eGFR ≥ 25 ml/min/1.73m2
    • Stable renal function prior to entry into the study defined as no more than 30% eGFR change in 3
    months prior to enrolment
    • Signed Informed Consent
    • Leeftijd ≥ 18 jaar
    • Body Mass index ≥ 27 kg/m2
    • Albuminurie ≥ 30 mg/g en ≤ 3500 mg/g
    • eGFR ≥ 25 ml/min/1.73m2
    • Stabiele nierfunctie voor inclusie, gedefinieerd als niet meer dan 30% eGFR verandering in 3
    maanden voor inclusie
    • Getekend Informed Consent
    E.4Principal exclusion criteria
    • Diagnosis with type 1 or type 2 Diabetes
    • Hba1c ≥ 6.5% at screening
    • Cardiovascular disease event in 3 months prior to enrollment
    • Treatment with GLP-1 RA < 4 weeks prior to screening
    • Uncontrolled thyroid disease TSH>6.0 mIU/L or <0.4 mIU/L at screening
    • Acute pancreatitis < 180 days prior to screening
    • History or presence of chronic pancreatitis
    • Females of child-bearing potential who are pregnant, breast-feeding or have intention of
    becoming pregnant or are not using adequate contraceptive measures
    • Gediagnosticeerd met type 1 of type 2 Diabetes
    • Hba1c ≥ 6.5% ten tijde van screening
    • Cardiovasculaire gebeurtenis in 3 maanden voor inclusie
    • Behandeling met GLP-1 RA < 4 vooraf aan screening
    • Ongecontroleerde schildklieraandoening met TSH>6.0 mIU/L of <0.4 mIU/L ten tijde van
    screening
    • Acute pancreatitis < 180 dagen vooraf aan screening
    • Voorgeschiedenis met of actuele chronische pancreatitis
    • Vrouwen in vruchtbare leeftijd die zwanger zijn, borstvoeding geven, intentie hebben om
    zwanger te worden of geen adequate anticonceptie gebruiken
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR).
    Verandering van baseline tot week 24 in de eerste ochtend urine albumine: creatinine ratio (UACR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to week 24, ie from just before start of treatment untill the end of the treatment period.
    Verandering van baseline tot week 24, dus tussen start van behandeling en einde van behandelperiode.
    E.5.2Secondary end point(s)
    Changes from baseline to week 24 in the following parameters:
    - eGFR (all subjects)
    - Iohexol measured GFR (46 subjects)
    - Change in UACR and eGFR during wash-out from week 24 to 28
    - Body weight and hip circumference
    - Systolic/diastolic blood pressure
    - Extracellular fluid using bio-impedance spectroscopy (Impedimed FP7)
    - High sensitivity CRP
    Verandering ten opzichte van de basislijn in:
    - eGFR (alle deelnemers),
    - Iohexol gemeten GFR (46 proefpersonen),
    - verandering in UACR en eGFR tijdens wash-out van week 24 tot 28
    - lichaamsgewicht
    - heupomtrek,
    - systolische / diastolische bloeddruk,
    - extracellulaire vloeistof,
    - zeer gevoelige CRP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline to week 24, ie from just before start of treatment untill the end of the treatment period.
    Verandering van baseline tot week 24, dus tussen start van behandeling en einde van behandelperiode.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 EEA11
    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
    Canada
    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
    Laatste bezoek van laatste deelnemer.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 98
    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 Decision2021-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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