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    Summary
    EudraCT Number:2020-000102-28
    Sponsor's Protocol Code Number:AFJ2020-1
    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:2020-03-13
    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 number2020-000102-28
    A.3Full title of the trial
    Does the glucagon-like peptide-1 receptor agonist semaglutide prevent deterioration in glycaemic control in prediabetic or diabetic patients with schizophrenia spectrum disorder treated with the antipsychotic compounds clozapine or olanzapine? A randomized placebo controlled clinical trial.
    Kan tillægsbehandling med glukagonlignende peptid-1 receptoragonisten semaglutid forebygge forværring af metaboliske forstyrrelser hos prediabetiske og diabtetiske skizofrene patienter, der er i behandling med olanzapin eller clozapin? Et randomiseret placebo kontrolleret klinisk studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does the glucagon-like peptide-1 receptor agonist semaglutide prevent deterioration of metabolic state in prediabetic or diabetic patients with schizophrenia treated with the antipsychotic compounds clozapine or olanzapine?
    Kan tillægsbehandling med glukagonlignende peptid-1 receptoragonisten semaglutid forebygge forværring af metaboliske forstyrrelser hos prediabetiske og diabtetiske skizofrene patienter, der er i behandling med olanzapin eller clozapin?
    A.4.1Sponsor's protocol code numberAFJ2020-1
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1232-3637
    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 SponsorMental Healt Center Copenhagen
    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 supportNovo Nordisk
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Hovedstaden Psykiatri
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPsychiatric Centre Copenhagen
    B.5.2Functional name of contact pointMette Kruse Klausen
    B.5.3 Address:
    B.5.3.1Street AddressHovedvejen 17, 1st floor
    B.5.3.2Town/ cityFrederiksberg
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004522649599
    B.5.5Fax number004538647077
    B.5.6E-mailmette.kruse.klausen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Ozempic
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Suspension 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 INNsemaglutid
    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 typeup to
    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 placeboSuspension 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
    Schizophrenia spectrum disorder
    F20-F29
    E.1.1.1Medical condition in easily understood language
    Mental Health
    Psykisk sygdom
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052792
    E.1.2Term Schizophrenia, undifferentiated type
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate long term (26 weeks) effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with a diagnose of schizophrenia, aged 18 years to 65 years who have initiated treatment with clozapine or olanzapine.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed oral and written consent.
    2. Diagnosed with a schizophrenia spectrum disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association.
    3. Initiating current daily treatment with clozapine or olanzapine, respectively, within 60 months.
    4. Age 18 years to 65 years (both included).
    5. Body mass index (BMI) ≥25 kg/m2.
    6. Diagnosed with prediabetes or type 2 diabetes, with the following plasma levels: Prediabetes: HbA1c 35-47 mmol/mol or fasting plasma glucose (FPG) 5.6-6.9 mM or 2-h during 75 mg OGGT 7.8-11.0 mM. The test result has to be confirmed on a different day. Type 2 diabetes: HbA1c 48-57 mmol/mol or fasting plasma glucose (FPG) 6.9-9.9 mM or 2h OGTT > 11 mM (although FPG and HbA1c might still be under the diagnostic range). The test result has to be confirmed on a different day.
    E.4Principal exclusion criteria
    1. Acute worsening of psychosis based on a clinical evaluation (score of 6 or 7 on the CGI-S scale).
    2. Coercive measures
    3. Females of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant.
    4. Women who are not willing to use an adequate contraceptive during the full length of the study.
    5. Patients treated with corticosteroids or other hormone therapy (except oestrogens).
    6. Any active substance abuse or dependence (except for nicotine).
    7. Impaired hepatic function (plasma liver transaminases >3 times upper normal limit).
    8. Impaired renal function (serum creatinine >150 μmol/l).
    9. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit).
    10. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months.
    11. Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg.
    12. Any condition that the investigator feels would interfere with trial participation.
    13. Receiving any experimental or pre-marketing drug within the last 3 months.
    14. Use of diabetes medication or weight-lowering pharmacotherapy within the preceding 3 months.
    15. Known type 1 diabetes.
    16. Suicidal behavior as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (except DXA scanning visits, please see Table 1) possible suicidality will be evaluated according to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action.
    17. Plasma HbA1c > 57 mmol/mol (tested twice) in which case the patient will be excluded from the study and transferred to general practitioner or hospital for diabetic treatment. No diabetic medication is allowed except for the trial medicine.
    18. Any known contraindication towards the treatment with semaglutide.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Glycaemic control is evaluated by the level of HbA1c on the day of inclusion (basal level) and after 26 weeks of treatment.
    E.5.2Secondary end point(s)
    Secondary endpoints include changes in body weight, hip and waist circumference, blood pressure, heart rate and plasma concentrations of insulin, C-peptide, glucagon and incretin hormones as well as plasma levels of glucose. Additionally, lipid profile, proteomics and bone markers will be evaluated in the fasting state. Insulin sensitivity and beta-cell function (evaluated by homeostatic model assessment (HOMA)). Additional endpoints include: body composition and bone density (evaluated by DXA-scanning), liver function (transaminases), liver fibrosis (fibrosis-4 (FIB-4) score), alcohol, tobacco and drug use, preference for sweet and fatty candy, psychopathology, activity and quality of life. In addition, blood samples for proteomic analyses and urine samples for measurement of oxidative stress will be collected. For patients enrolled in the study, all endpoints will initially be collected and several repeated during full study duration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will initially be collected and several repeated during full study duration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned3
    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
    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 months
    E.8.9.1In the Member State concerned days
    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: 100
    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 state104
    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)
    If relevant patients will be transferred to general practioner or hospital for diabetic treatment
    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 Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-19
    P. End of Trial
    P.End of Trial StatusOngoing
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