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    EudraCT Number:2021-006752-14
    Sponsor's Protocol Code Number:DualActionWeightLossinIIH1
    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:2022-01-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2021-006752-14
    A.3Full title of the trial
    Glucagone Like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as treatment of Idiopathic Intracranial Hypertension
    Glukagonlignende peptid-receptor (GLP-1R) agonist-assisteret program med hurtigt vægttab som behandling ved Idiopatisk intrakraniel hypertension (IIH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Program with Medically assisted Rapid Weight Loss as treatment of Idiopathic Intracranial Hypertension
    Hurtigt vægttab assisteret med medicin som behandling for idiopatisk intrkraniel hypertension
    A.3.2Name or abbreviated title of the trial where available
    Dual Action Weight loss in IIH
    Dual Action Vægttab ved IIH
    A.4.1Sponsor's protocol code numberDualActionWeightLossinIIH1
    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 SponsorRigshospitalet, Neurologisk afdeling
    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 Foundation
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Neurologisk afdeling
    B.5.2Functional name of contact pointDansk Hovedpinecenter
    B.5.3 Address:
    B.5.3.1Street AddressValdemar Hansens Vej 5
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.4Telephone numberDK4538 63 20 62
    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 Yes
    D. name Ozempic
    D. of the Marketing Authorisation holderNovo Nordisk A/S
    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.3.1Product nameOzempic
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    Rectal use
    Subcutaneous 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 milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 2.25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Intracranial Hypertension (IIH) is a disease in which the intracranial pressure is pathologically elevated. This can cause blindness, chronic, severe headache, and cognitive dysfunction. IIH is associated with obesity, and the only treatment which controls the disease is weight loss.
    Idiopatisk intrakraniel hypertension er en relativt sjælden tilstand, hvor væsketrykket i hjernen er forhøjet. Patienter med IIH risikerer synsstab, kronisk hovedpine og koncentrationsbesvær. IIH behandles med vægttab og vanddrivende medicin. Den eneste kendte behandling, der reelt ændrer på sygdommens aktivitet, er vægttab.
    E.1.1.1Medical condition in easily understood language
    Idiopathic Intracranial Hypertension (IIH) is a disease in which the brain pressure is elevated. This can cause blindness, chronic, severe headache, and cognitive dysfunction.
    Idiopatisk intrakraniel hypertension er en relativt sjælden tilstand, hvor væsketrykket i hjernen er forhøjet. Patienter med IIH risikerer synsstab, kronisk hovedpine og koncentrationsbesvær.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10004277
    E.1.2Term Benign intracranial hypertension
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We wish to investigate whether a dual-action weight loss program combining the benefits of a very low calorie diet (VLCD) at the time of diagnosis with a GLP1R analogue for long term weight maintenance is a better treatment option than our regular calorie restricted diet, which is the current standard of care.
    First, we want to investigate the use of a weight loss program for the treatment of IIH in which a 10-15 % weight loss is chieved in a very short time. We will use a randomized controlled study design with 2 treatment groups (A and B).

    We hypothesize that an initial VLCD (group A) would,

    1. Reduce opening pressure in new-onset IIH significantly more than our standard of care (Group B). The primary outcome is ICP after 8 weeks and weight loss (% of body weight) compared to baseline values in the two groups A and B respectively.
    E.2.2Secondary objectives of the trial
    Second, we want to investigate whether the use of a GLP-1R analogue (Semaglutide®) can sustain a long-term weight loss after an initial VLCD in patients with new-onset IIH. A sustained weight loss of 10-20 % is the only known disease modifying treatment(19). We hypothesize that,

    2. 8 months follow-up treatment with Semaglutide® after 8 weeks on a VLCD will result in a sustained, total weight loss of 10-20 % of total baseline body weight after 10 months in group A and a significant reduction in opening pressure after 10 months in comparison with group B.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1) Transorbital Ultrasonography of the Optic Nerve as a marker of Intracranial Pressure in Idiopathic Intracranial Hypertension: A Longitudinal study
    Objective: To investigate the usefullness of transorbital sonography as a non-invasive marker of intracranial pressure in IIH.

    2) Nonalcoholic fatty liver disease in Idiopathic Intracranial Hypertension
    Objective: To map the prevalence of comorbid fatty liver disease in IIH and to investigate any correlation to ammoniemia and cognitive function
    1) Transorbital ultralyd af synsnerven som en markør ofr øget intrakranielt tryk i Iidopatisk Intrakraniel Hypertension: Et longitudinelt studie.
    Formål: At undersøge anvendeligheden af transorbital ultralydsundersøgelse af synsnerven som en non.invasig markør for øget intrakranielt tryk i IIH.

    2) Nonalkoholisk fedtlever sygdom i Idiopatisk Intrakraniel Hypertension
    Formål: At undersøge prævalensen af NAFLD i patienter med IIH og undersøg eom der er korrelation med ammoniæmi og kognitiv dysfunktion.
    E.3Principal inclusion criteria
    • Part 1: Suspected, new onset IIH with papilledema. Part 2: Confirmed new onset IIH with papilledema according to Friedmann et al.
    • Female, 18-65 years
    • BMI ≥ 27
    • Written, informed consent
    • Use of anticontraceptives with a failure rate of <1%
    • Del 1: Mistanke om nyopstået IIH. Del 2: Bekræftet nyopstået IIH med papilødem jf. Friedmann kriterierne
    • Kvinde, 18-65 år
    • BMI ≥ 27
    • Skriftligt informeret samtykke
    • Prævention med <1 fejlprocent
    E.4Principal exclusion criteria
    • Unable to provide written informed consent or participate
    • Malignant IIH with visual threat that requires VP-shunting, optic nerve sheet fenestration or other surgical CSF diversion
    • Pregnancy or breastfeeding
    • Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events or affect appetite (other than topiramate or acetazolamid)
    • Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy)
    • History or family history of thyroid carcinomas or other MEN1/MEN2 carcinomas
    • History of bariatric surgery
    • Other severe/uncontrolled mental or physical disease

    • Malign IIH med kirurgisk indikation
    • Graviditet eller amning
    • behandling med antidiabetika, blodfortyndende eller medicin, der øger risikoen for alvorlige bivirkninger eller påvirker appetitten fraset Topiramate eller Acetazolamid
    • Diabetes, hjertesvigt, alvorlig vaskulær sygdom, pankreatitis, alvorlig ophthalmologisk sygdom udover IIH (fx retinopati)
    • Anamnese eller familiær disposition til thyreoidea carcinomas /MEN1/MEN2 karcinomer
    • Tdiligere bariatrisk kirurgi
    • Andne alvorlig fysisk eller psykisk sygdom
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is ICP after 8 weeks and total weight lost (% of body weight).
    Primære effektmål er intrakranielt tryk og vægttab (% af kropsvægt)
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 uger
    E.5.2Secondary end point(s)
    • Neuroophthalmological outcome (8 weeks, 4 and 10 months)
    o Degree of papilledema (Frisén grade)
    o Visual field perimetric mean deviation (MD) by automated perimetry
    o Optical coherence tomography (OCT) changes including enhanced depth imaging (EDI) OCT, confocal scanning laser ophthalmoscopy (cSLO) and OCT angiography (OCTA)
    • Improvement in optic disc elevation and optic nerve sheath diameter assessed with ultrasonography of the optic nerves.
    • Headache outcome (8 weeks, 4 and 10 months)
    • Headache days per month
    • Headache disability (HURT questionnaire)
    • Headache intensity (8 weeks, 4 and 10 months)
    • Use of headache medication
    • Improvement in non-alcoholic fatty liver disease
    • Percentage in remission after 10 months (absence of papilledema with or withou ICP < 25 mmH2O)
    • Reduction in body fat percentage and truncal adiposity (10 months DEXA scan)
    • Quality of life ( WHO QoL questionnaire (short version), 8 weeks and 10 months)
    • Feasibility
    • Drop-out before 8 weeks and 10-month follow-up
    • Percentage of patients in ketosis (ketones in urine and blood) after 4 weeks and 8 weeks
    • Difficulty following diet and patient satisfaction (scale of 0-10) at 8 weeks and after 10 months
    • Use of ICP regulating medication (daily dose and length of treatment)
    • Biomarkers in CSF, blood and saliva (at baseline, 8 weeks and 10 months)
    • Change in cardiometabolic parameters (HOMA2IR, HbA1c, glucose, serum lipids, urine sample, etc.), samples collected with patients fasting (at baseline, 8 weeks and 10 months)
    • Adverse effects including biochemical assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Eight weeks and 10 months after inclusion, respectively
    Efter hhv. 8 uger og 10 måneder efter inklusion
    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. 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E. description
    Patients are randomized for intervention (very low calorie diet and semaglutide) or no intervention.
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 50
    F.1.3Elderly (>=65 years) No
    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 No
    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 Information not present in EudraCT
    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 state50
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Neurologisk Afdeling, Odense Universitetshospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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