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    Summary
    EudraCT Number:2021-004452-42
    Sponsor's Protocol Code Number:STABIL-NOR
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-11
    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 ConcernedNorway - NOMA
    A.2EudraCT number2021-004452-42
    A.3Full title of the trial
    An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study).
    A.3.2Name or abbreviated title of the trial where available
    STABIL-NOR
    A.4.1Sponsor's protocol code numberSTABIL-NOR
    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 SponsorHelse Bergen HF
    B.1.3.4CountryNorway
    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 A/S (provides study drug)
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelse Bergen HF
    B.5.2Functional name of contact pointCTU at Research and Innovation Dep
    B.5.3 Address:
    B.5.3.1Street AddressJonas Lies vei 65
    B.5.3.2Town/ cityBergen
    B.5.3.4CountryNorway
    B.5.6E-mailforskningsstotte@helse-bergen.no
    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
    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.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,24 to 2,4
    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 placeboInjection
    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
    Drug induced weight gain from anti-psychotic drug treatment in patients with schizophrenia.

    Treatment with semaglutide, a glucagon-like peptide receptor agonist used to treat diabetes and approved in USA and Europe for treating obesity, could be a way to combat weight gain and achieve glycemic and also metabolic control for people with schizophrenia treated with antipsychoti drugs, however patients with serious mental illness is commonly excluded from phase 3 studies.
    E.1.1.1Medical condition in easily understood language
    Treatment induced weight gain/obesity.
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo in patients with schizophrenia spectrum disorders and a BMI of equal to or above 30 kg/m2 or BMI equal to or above 27 kg/m2 in addition to prediabetes determined by fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/l and/or HbA1c between 39-47 mmol/mol (on two occasions at least 24 hours apart) on body weight.
    E.2.2Secondary objectives of the trial
    To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo in patients with schizophrenia spectrum disorders and a BMI of equal to or above 30 kg/m2 or BMI equal to or above 27 kg/m2 in addition to prediabetes determined by FPG between 5.6 and 6.9 mmol/l and/or HbA1c between 39-47 mmol/mol (on two occasions at least 24 hours apart) on
    • fasting blood glucose/ HbA1c/ triglycerides/ cholesterols
    • cognition
    • time until discontinuation of antipsychotic drug treatment
    • perceived body image
    • economic outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, also including activities to determine suitability for the trial as for example the screening for eligibility.

    2. Men or woman aged between 18 and 70 years, both years included, at the time of signing informed consent.

    3. BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of prediabetes determined with either fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/l and/or HbA1c between 39-47 mmol/mol measured on two occasions at least 24 hours apart.
    These measures will be done at the V1 and the V2 visit, or alternatively a measurement of FPG or HbA1c within the borders of prediabetes performed in the regular clinical treatment during last 2 weeks before screening can be used as the first of the two occasions.

    4. A diagnosis within the schizophrenia-spectrum according to International classification of diseases version - 10 (ICD-10): F 20, F 22, F 23, F 25, F 28, F 29.

    5. AP drug use for at least 3 weeks prior to starting study medication and a treatment plan/recommendation for further AP drug use for at least the next 6 months. Antipsychotic drug discontinuation during the trial will not result in exclusion from further participation in the study.
    E.4Principal exclusion criteria
    1. With relation to glycemic regulation:
    a. Type 1 or Type 2 diabetes present or in history.
    b. HbA1c >48 mmol/mol.
    c. Latent autoimmune diabetes in adults (LADA).
    d. Treatment with a GLP-1 receptor agonist last 6 months before screening.
    e. Treatment with insulin or other glucose-lowering drug(s) last 3 months before screening.

    2. Thyreoid stimulating hormone (TSH) within the normal range-Haukeland university hospital: 11-19 years: 0,51-4,30 mIU/L, >20 years: 0,40-4,50 mIU/L.

    3. Medical or surgical treatment to reduce weight last 6 months before screening, or planned surgical treatment to reduce weight.

    4. Safety criteria:
    a. A personal or family history of medullary thyreoid cancer or multippel endokrin neoplasi 2 (MEN 2).
    b. A history of pancreatitis during the last 12 months before inclusion.
    c. A history of myocardial infarction/instable angina/stroke during the last 12 months before inclusion.
    d. A prior serious hypersensitivity reaction to semaglutide or to any of the excipients or otherwise as specified in the SPC of Wegovy.
    e. A history of eating disorders defined: a specialist diagnosed eating disorder of ICD-10 F50 last ten years.
    f. Woman of childbearing potential (WOCBP) who are not using adequate contraceptive methods (ref. appendix 4, section 10.4.2). Contraception must be continued for 6 months after the stop of study medication.
    g. Breastfeeding.
    h. Disorders, unwillingness or inability which in the investigator’s opinion might jeopardize the subject’s safety or compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation after 26 weeks of treatment.
    E.5.2Secondary end point(s)
    The secondary endpoints addressing secondary objectives:
    • Change from baseline at week 0 to week 26 in:
    - HbA1c (%, mmol /mol)
    - FPG (mmol/l)
    - Fasting serum insulin (mIU/L) and insulin C peptid
    - Lipids (mg/dL) (total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, free fatty acids, triglycerides)

    • Change from baseline at week 0 to week 26 in cognition as assessed by the Brief Assessment of Cognition in Schizophrenia (BACS)

    • Time (in days) until discontinuation of AP drug treatment as evaluated through interviews and the measurement of serum levels of antipsychotic drugs

    • Change from baseline at week 0 to week 26 in the Stunkard scale

    • The economic outcomes will be assessed in the following way: Analysis of incremental cost-effectiveness ratio (ICER) and a cost-utility analysis based on an well-validated instrument to capture changes in quality of life during the intervention period. This outcomes will also use register-data collected during the 12 months after participation in the RCT. Change in quality of life from baseline at week 0 to week 26 will be assessed by the Manchester Short Assesment of quality of life (MANSA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation after 26 weeks of treatment.
    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 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 concerned4
    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
    End of trial is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the schedule of activities for the last participant in the study (estimated date 31-Aug-2026). However, data collection from registry continues until 12 months after the last administration of study treatment and database lock is therefore estimated to take place 31-Dec-2027.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days15
    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: 40
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients on anti-psychotic treatment suffering from schizophrenia, a serious psyciatric disorder.
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    Study participants will after conclusion of the study be followed up according to standard of care.
    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 Decision2022-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-04
    P. End of Trial
    P.End of Trial StatusOngoing
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