Back to resultsThe Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure (IIH:DUAL)
Primary Purpose
Idiopathic Intracranial Hypertension, Intracranial Pressure, Obesity
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Semaglutide
Very Low Calorie Diet
Dietician counselling
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring Idiopathic Intracranial Hypertension, Papilledema, Weight loss, Obesity, Pseudotumor Cerebri Syndrome, Intracranial Pressure
Eligibility Criteria
Inclusion Criteria: Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria BMI ≥ 27 Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide Written, informed consent Exclusion Criteria: Unable to provide written informed consent or participate Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting Pregnancy or breastfeeding Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events 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 Multiple Endocrine Neoplasias (MEN1/MEN2) History of bariatric surgery Known hypersensitivity to any contents of Semaglutide® Other severe/uncontrolled mental or physical disease
Sites / Locations
- Danish Headache Center, Department of Neurology, RigshospitaletRecruiting
- Headache clinic, Department of Neurology, Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Semaglutide
Standard care (dietician)
Arm Description
Semaglutide up-titration to 2.4 mg for 10 months initially combined with a Very Low Calorie Diet (800 kcal/day) for 8 weeks. Counselling by dietician Standard medical treatment of intracranial hypertension
Standard weight loss intervention Counselling by dietician Standard medical treatment of intracranial hypertension
Outcomes
Primary Outcome Measures
Weight
Weight change (%)
Intracranial pressure
Change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry
Intracranial pressure
Change in lumbar opening pressure (%)
Secondary Outcome Measures
Weight
Weight change (%)
Intracranial Pressure
Change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry
Intracranial Pressure
Change in lumbar opening pressure (%)
Quality of Life
Change in total score of Quality of Life (psychological, social, physical, environmental) assessed by the World Health Organization Quality of Life Brief Version Questionnaire (0-100; 0 worst, 100 best)
Headache burden measured by HURT questionnaire
Change in summation of scores in the questionnaire "Headache Under Response to Treatment Questionnaire" (HURT); 0-24 points were higher numbers are worse outcome
Change in Papilledema
Change in Frisén Grade (0-5, 0 minimal, 5 worst)
Visual fields
Perimetric mean deviation (decibel) by Humphrey automated perimetry
EDI-OCT
Change in Papillary thickness (um) measured by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT)
Optic disc elevation
Optic disc elevation (mm) measured by transorbital ultrasonography, (average of 3 scans of each eye with papilledema)
Remission
Proportion of patients with abscence of papilledema with or without intracranial pressure <25 cm cerebrospinal fluid
Change in fat mass
Change in body fat percentage measured by Dual Energy X-ray Absorptiometry compared to baseline
Total fat mass
Body fat percentage measured by Dual Energy X-ray Absorptiometry
Feasibility
Drop-out rate (proportion of patients withdrawing from participation)
Need of intracranial pressure-lowering medication_1
Dose (mg) of intracranial pressure-lowering medication needed (Acetazolamide, Topiramate, diuretics)
Fatty liver prevalence
Prevalence of non-alcoholic fatty liver disease evaluated by ultrasonography (subjectively assessed density of liver parenchyma compared to hepatic perivascular density and renal density), assessed by an experienced radiologist with specialization in ultrasonography
Monthly headache days
Number of days with headache for the past 30 days preceding visit
Headche severity
Number of days with mild, moderate, and severy headache, respectively, in the past 30 days preceding visit
Headache medication - Acute analgesic use
Number of days with need of acute analgesic treatment for headache
Headache medication - preventive medication
Need of preventive medical treatment for headache
Optic nerve sheath diameter
Optic nerve sheath diameter (mm) measured by transorbital ultrasonography (average of 3 scans of each eye with papilledema)
Peripapillary capillary density
Change in peripapillary capillary density (ratio of pixels of perpapillary vessels and pixels in the foveal area evaluated by Optic Coherence Tomography Angiography
Peripapillary artery-to-venule ratio
Change in peripapillary artery-to-venule diameter ratio measured by confocal Scanning Laser Ophtalmoscopy
Truncal fat
Change in percentage of truncal adiposity measured by Dual Energy X-ray Absorptiometry
Android-gynoid-ratio
Change in ratio of Android versus gynoid fat percentage using Dual Energy X-ray Absorptiometry
Adverse events
Number of adverse events overall, and sub-categorized into adverse events (AE) (any event happening during attachment to the project) and severe adverse events (SAE) in case of the following conditions: Hospitalization or prolongation of hospitalization, death, life-threatening or significant disability/incapacity
Need of intracranial pressure-lowering medication_2
Number of patients in need of any intracranial pressure-lowering drug (Acetazolamide, Topiramate, diuretics)
Insulin like-Growth-Factor-1
Level of Insulin like-Growth-Factor-1 in serum (ug/L) in women not taking estrogen-containing contraceptives.
Insulinlike Growth Factor Binding Protein-3
Level of Insulinlike Growth Factor Binding Protein-3 in serum (ug/L) in women not taking estrogen-containing contraceptives.
Growth hormone
Level of growth hormone in serum ug(L) in women not taking estrogen-containing contraceptives.
Lutropin
Level of Lutropin in serum (IU/L) in women not taking estrogen-containing contraceptives.
Follitropin
Level of Follitropin in serum (IU/L) in women not taking estrogen-containing contraceptives.
Testosteron
Level of testosteron in serum (nmol/L) in women not taking estrogen-containing contraceptives.
Estradiol
Level of estradiol in serum (nmol/L) in women not taking estrogen-containing contraceptives.
Sex-Hormone Binding Globulin
Level of Sex-Hormone Binding Globulin in serum (nmol/L) in women not taking estrogen-containing contraceptives.
Anti-Müllerian Hormone
Level of Anti-Müllerian Hormone (pmol/L) in serum in women not taking estrogen-containing contraceptives.
Dehydroepiandrosterone
Level of Dehydroepiandrosterone (DHEAS) in serum (umol/L) in women not taking estrogen-containing contraceptives.
Androstenedion
Level of androstenedion (nmol/L) in serum in women not taking estrogen-containing contraceptives.
17-hydroxyprogesterone (mg/d)
Level of 17-hydroxyprogesterone (mg/d) in serum in women not taking estrogen-containing contraceptives.
Cortisol 0 min
Level of cortisol (nmol/L) in serum in women not taking estrogen-containing contraceptives.
Cortisol 30 min
Level of cortisol (nmol/L) in serum 30 minutes after stimulation with 0,25 mg SynACHTen in women not taking estrogen-containing contraceptives.
Pituitary adenylate cyclase-activating peptide (PACAP) Pituitary adenylate cyclase-activating peptide Pituitary adenylate cyclase-activating peptide
Level (picograms per milliliter in plasma and cerebrospinal fluid) of Pituitary adenylate cyclase-activating peptide (PACAP)
Calcitonin Gene Related Peptide
Calcitonin Gene Related Peptide (CGRP) level pg/mL (picograms per milliliter in plasma and cerebrospinal fluid)
Change in bone marker (CTX)
Change in carboxy-terminal collagen crosslinks (CTX) level (nanograms per liter)
Change in bone marker (PiNP)
Change in procollagen type I N-propeptide (PiNP) level (micrograms per liter) compared to baseline
Regional bone density
Change in regional bone density in grams/square cm (g/cm2) and T- and Z-scores of hip and spine measured by Dual Energy X-ray Absorptiometry compared to baseline
Androgen metabolism_1
Ratio between Etiocholanolone and Androsterone (ng/mg) in 24-hour urine
Androgen metabolism_2
Ratio between 5-alpha-tetrahydrocortisol (5a-THF) and tetrahydrocortisol (THF) in 24-hour urine
Androgen metabolism_3
Level of testosterone in 24-hour urine (ng/L)
Androgen metabolism_4
Level of 3-alpha-androstanediol in 24-hour urine (nmol/L)
Androgen metabolism_5
Level of 11-oxygenated androgens (11-OHA4) (pg/L) in 24-hour urine
Intrathecal Semaglutide
Level of semaglutide in cerebrospinal fluid (picomol/L)
Ammoniaemia_1
Levels of plasma ammonium (umol/L)
Ammoniaemia_2
Correlation between plasma ammonium (umol/L) and presence of fatty liver disease as indicated by liver ultrasonography
Ketosis
Proportion of patients in ketosis measured by urine stix
Change in metabolic parameters
Change in Homeostatic Model for Insulin Resistance (HOMA2IR) compared to baseline
Change in metabolic parameters
Change in glycated hemoglobin (mmol/mol) compared to baseline
Full Information
NCT ID
NCT06027567
First Posted
February 23, 2023
Last Updated
September 7, 2023
Sponsor
Rigmor Højland Jensen
Collaborators
Rigshospitalet, Denmark, Odense University Hospital, University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT06027567
Brief Title
The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure
Acronym
IIH:DUAL
Official Title
Glucagon-like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as Treatment of Idiopathic Intracranial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rigmor Højland Jensen
Collaborators
Rigshospitalet, Denmark, Odense University Hospital, University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
50 patients with verified new-onset Idiopathic Intracranial Hypertension are randomly allocated to standard weight management (dietician counselling) or trial intervention consisting of subcutaneous injections with Semaglutide for 10 months combined, in the initial 8 weeks following diagnosis, with a Very Low Calorie-Diet (max 800 kcal/day)
Detailed Description
Idiopathic Intracranial Hypertension is primarily observed in obese female and weight management promotes disease control by yet unsettled mechanisms. Effective, fast and lasting weight loss is crucial, however, hard to achieve. Current weight management strategy in IIH in Denmark is counselling by a dietician. This study investigates whether an initial Very Low Calorie Diet (max 800 kcal/day) for 8 weeks following the diagnosis combined with GLP1-RA treatment throughout 10 months is tolerated and more efficient in achieving substantial weight loss and reduction of intracranial pressure. Furthermore, a number of secondary outcomes are measured including headache burden, quality of life, structure and function of the optic nerve, non-invasive surrogate markers of intracranial pressure, body fat mass, bone health, fatty liver disease and a range of cerebrospinal-, blood- and urine markers of i.a. the hormonal, inflammatory, metabolic, and headache biomarker profile.
The intervention may candidate as a future first-line treatment regime.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension, Intracranial Pressure, Obesity, Pseudotumor Cerebri Syndrome, Papilledema, Weight Loss
Keywords
Idiopathic Intracranial Hypertension, Papilledema, Weight loss, Obesity, Pseudotumor Cerebri Syndrome, Intracranial Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized controlled clinical treatment trial Patients are randomly assigned 1:1 to standard-of-care or intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
Semaglutide up-titration to 2.4 mg for 10 months initially combined with a Very Low Calorie Diet (800 kcal/day) for 8 weeks.
Counselling by dietician Standard medical treatment of intracranial hypertension
Arm Title
Standard care (dietician)
Arm Type
Active Comparator
Arm Description
Standard weight loss intervention Counselling by dietician Standard medical treatment of intracranial hypertension
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
Ozempic, Wegovy
Intervention Description
Subcutaneous once-weekly injections of Semaglutide uptitrating to a maximum of 2.4 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Very Low Calorie Diet
Intervention Description
Very Low Calorie Diet (max 800 kcal/day) using Nupo Diet meal replacement products
Intervention Type
Behavioral
Intervention Name(s)
Dietician counselling
Intervention Description
Counselling by a dietician on weight loss through behavioural changes and life style intervention
Primary Outcome Measure Information:
Title
Weight
Description
Weight change (%)
Time Frame
8 weeks
Title
Intracranial pressure
Description
Change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry
Time Frame
8 weeks
Title
Intracranial pressure
Description
Change in lumbar opening pressure (%)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Weight
Description
Weight change (%)
Time Frame
10 months
Title
Intracranial Pressure
Description
Change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry
Time Frame
10 months
Title
Intracranial Pressure
Description
Change in lumbar opening pressure (%)
Time Frame
10 months
Title
Quality of Life
Description
Change in total score of Quality of Life (psychological, social, physical, environmental) assessed by the World Health Organization Quality of Life Brief Version Questionnaire (0-100; 0 worst, 100 best)
Time Frame
8 weeks + 10 months
Title
Headache burden measured by HURT questionnaire
Description
Change in summation of scores in the questionnaire "Headache Under Response to Treatment Questionnaire" (HURT); 0-24 points were higher numbers are worse outcome
Time Frame
8 weeks + 10 months
Title
Change in Papilledema
Description
Change in Frisén Grade (0-5, 0 minimal, 5 worst)
Time Frame
8 weeks + 10 months
Title
Visual fields
Description
Perimetric mean deviation (decibel) by Humphrey automated perimetry
Time Frame
8 weeks + 10 months
Title
EDI-OCT
Description
Change in Papillary thickness (um) measured by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT)
Time Frame
8 weeks + 10 months
Title
Optic disc elevation
Description
Optic disc elevation (mm) measured by transorbital ultrasonography, (average of 3 scans of each eye with papilledema)
Time Frame
Baseline + 8 weeks + 10 months
Title
Remission
Description
Proportion of patients with abscence of papilledema with or without intracranial pressure <25 cm cerebrospinal fluid
Time Frame
8 weeks + 10 months
Title
Change in fat mass
Description
Change in body fat percentage measured by Dual Energy X-ray Absorptiometry compared to baseline
Time Frame
8 weeks + 10 months
Title
Total fat mass
Description
Body fat percentage measured by Dual Energy X-ray Absorptiometry
Time Frame
Baseline + 8 weeks + 10 months
Title
Feasibility
Description
Drop-out rate (proportion of patients withdrawing from participation)
Time Frame
8 weeks + 10 months
Title
Need of intracranial pressure-lowering medication_1
Description
Dose (mg) of intracranial pressure-lowering medication needed (Acetazolamide, Topiramate, diuretics)
Time Frame
8 weeks + 10 months
Title
Fatty liver prevalence
Description
Prevalence of non-alcoholic fatty liver disease evaluated by ultrasonography (subjectively assessed density of liver parenchyma compared to hepatic perivascular density and renal density), assessed by an experienced radiologist with specialization in ultrasonography
Time Frame
Baseline + 8 weeks + 10 months
Title
Monthly headache days
Description
Number of days with headache for the past 30 days preceding visit
Time Frame
Baseline + 8 weeks + 10 months
Title
Headche severity
Description
Number of days with mild, moderate, and severy headache, respectively, in the past 30 days preceding visit
Time Frame
Baseline + 8 weeks + 10 months
Title
Headache medication - Acute analgesic use
Description
Number of days with need of acute analgesic treatment for headache
Time Frame
Baseline + 8 weeks + 10 months
Title
Headache medication - preventive medication
Description
Need of preventive medical treatment for headache
Time Frame
Baseline + 8 weeks + 10 months
Title
Optic nerve sheath diameter
Description
Optic nerve sheath diameter (mm) measured by transorbital ultrasonography (average of 3 scans of each eye with papilledema)
Time Frame
Baseline + 8 weeks + 10 months
Title
Peripapillary capillary density
Description
Change in peripapillary capillary density (ratio of pixels of perpapillary vessels and pixels in the foveal area evaluated by Optic Coherence Tomography Angiography
Time Frame
Baseline + 8 weeks + 10 months
Title
Peripapillary artery-to-venule ratio
Description
Change in peripapillary artery-to-venule diameter ratio measured by confocal Scanning Laser Ophtalmoscopy
Time Frame
Baseline + 8 weeks + 10 months
Title
Truncal fat
Description
Change in percentage of truncal adiposity measured by Dual Energy X-ray Absorptiometry
Time Frame
Baseline + 8 weeks + 10 months
Title
Android-gynoid-ratio
Description
Change in ratio of Android versus gynoid fat percentage using Dual Energy X-ray Absorptiometry
Time Frame
Baseline + 8 weeks and 10 months
Title
Adverse events
Description
Number of adverse events overall, and sub-categorized into adverse events (AE) (any event happening during attachment to the project) and severe adverse events (SAE) in case of the following conditions: Hospitalization or prolongation of hospitalization, death, life-threatening or significant disability/incapacity
Time Frame
8 weeks + 10 months
Title
Need of intracranial pressure-lowering medication_2
Description
Number of patients in need of any intracranial pressure-lowering drug (Acetazolamide, Topiramate, diuretics)
Time Frame
Baseline + 8 weeks + 10 months
Title
Insulin like-Growth-Factor-1
Description
Level of Insulin like-Growth-Factor-1 in serum (ug/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Insulinlike Growth Factor Binding Protein-3
Description
Level of Insulinlike Growth Factor Binding Protein-3 in serum (ug/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Growth hormone
Description
Level of growth hormone in serum ug(L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Lutropin
Description
Level of Lutropin in serum (IU/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Follitropin
Description
Level of Follitropin in serum (IU/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Testosteron
Description
Level of testosteron in serum (nmol/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Estradiol
Description
Level of estradiol in serum (nmol/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Sex-Hormone Binding Globulin
Description
Level of Sex-Hormone Binding Globulin in serum (nmol/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Anti-Müllerian Hormone
Description
Level of Anti-Müllerian Hormone (pmol/L) in serum in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Dehydroepiandrosterone
Description
Level of Dehydroepiandrosterone (DHEAS) in serum (umol/L) in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Androstenedion
Description
Level of androstenedion (nmol/L) in serum in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
17-hydroxyprogesterone (mg/d)
Description
Level of 17-hydroxyprogesterone (mg/d) in serum in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Cortisol 0 min
Description
Level of cortisol (nmol/L) in serum in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Cortisol 30 min
Description
Level of cortisol (nmol/L) in serum 30 minutes after stimulation with 0,25 mg SynACHTen in women not taking estrogen-containing contraceptives.
Time Frame
Baseline
Title
Pituitary adenylate cyclase-activating peptide (PACAP) Pituitary adenylate cyclase-activating peptide Pituitary adenylate cyclase-activating peptide
Description
Level (picograms per milliliter in plasma and cerebrospinal fluid) of Pituitary adenylate cyclase-activating peptide (PACAP)
Time Frame
Baseline + 8 weeks + 10 months
Title
Calcitonin Gene Related Peptide
Description
Calcitonin Gene Related Peptide (CGRP) level pg/mL (picograms per milliliter in plasma and cerebrospinal fluid)
Time Frame
Baseline + 8 weeks + 10 months
Title
Change in bone marker (CTX)
Description
Change in carboxy-terminal collagen crosslinks (CTX) level (nanograms per liter)
Time Frame
Baseline + 8 weeks + 10 months
Title
Change in bone marker (PiNP)
Description
Change in procollagen type I N-propeptide (PiNP) level (micrograms per liter) compared to baseline
Time Frame
baseline + 8 weeks + 10 months
Title
Regional bone density
Description
Change in regional bone density in grams/square cm (g/cm2) and T- and Z-scores of hip and spine measured by Dual Energy X-ray Absorptiometry compared to baseline
Time Frame
Baseline + 8 weeks + 10 months
Title
Androgen metabolism_1
Description
Ratio between Etiocholanolone and Androsterone (ng/mg) in 24-hour urine
Time Frame
Baseline + 8 weeks + 10 months
Title
Androgen metabolism_2
Description
Ratio between 5-alpha-tetrahydrocortisol (5a-THF) and tetrahydrocortisol (THF) in 24-hour urine
Time Frame
Baseline + 8 weeks + 10 months
Title
Androgen metabolism_3
Description
Level of testosterone in 24-hour urine (ng/L)
Time Frame
Baseline + 8 weeks + 10 months
Title
Androgen metabolism_4
Description
Level of 3-alpha-androstanediol in 24-hour urine (nmol/L)
Time Frame
Baseline + 8 weeks + 10 months
Title
Androgen metabolism_5
Description
Level of 11-oxygenated androgens (11-OHA4) (pg/L) in 24-hour urine
Time Frame
Baseline + 8 weeks + 10 months
Title
Intrathecal Semaglutide
Description
Level of semaglutide in cerebrospinal fluid (picomol/L)
Time Frame
10 months
Title
Ammoniaemia_1
Description
Levels of plasma ammonium (umol/L)
Time Frame
Baseline + 8 weeks + 10 months
Title
Ammoniaemia_2
Description
Correlation between plasma ammonium (umol/L) and presence of fatty liver disease as indicated by liver ultrasonography
Time Frame
Baseline + 8 weeks + 10 months
Title
Ketosis
Description
Proportion of patients in ketosis measured by urine stix
Time Frame
8 weeks + 10 months
Title
Change in metabolic parameters
Description
Change in Homeostatic Model for Insulin Resistance (HOMA2IR) compared to baseline
Time Frame
8 weeks + 10 months
Title
Change in metabolic parameters
Description
Change in glycated hemoglobin (mmol/mol) compared to baseline
Time Frame
8 weeks + 10 months
Other Pre-specified Outcome Measures:
Title
Omics
Description
Metabolomic and proteomic profile, exploratory analyses
Time Frame
Baseline + 8 weeks + 10 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria
BMI ≥ 27
Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide
Written, informed consent
Exclusion Criteria:
Unable to provide written informed consent or participate
Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting
Pregnancy or breastfeeding
Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
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 Multiple Endocrine Neoplasias (MEN1/MEN2)
History of bariatric surgery
Known hypersensitivity to any contents of Semaglutide®
Other severe/uncontrolled mental or physical disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rigmor H Jensen, Professor
Phone
0045-38633059
Email
rigmor.jensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Nadja Skadkær Hansen, MD
Phone
0045-38633553
Email
nadja.skadkaer.hansen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigmor H Jensen, Professor
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center, Department of Neurology, Rigshospitalet
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadja S Hansen, MD
Phone
0045-38633553
Email
nadja.skadkaer.hansen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Rigmor H Jensen, Professor
Phone
0045-38633059
Email
rigmor.jensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Nadja S Hansen, MD
Facility Name
Headache clinic, Department of Neurology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmar Beier, MD
Phone
0045-65415604
Email
dagmar.beier@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Dagmar Beier, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure
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