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Idiopathic Intracranial HypertensionPhase 4IIH:DUALNCT06027567

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

A Phase 4 study testing Semaglutide, Very Low Calorie Diet and Dietician counselling in people with Idiopathic Intracranial Hypertension and Intracranial Pressure, run by Rigmor Højland Jensen at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Semaglutide, Very Low Calorie Diet and Dietician counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesDenmark
Study dates
2 Sep 2022to 28 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • History of bariatric surgery
  • Known hypersensitivity to any contents of Semaglutide®
  • Other severe/uncontrolled mental or physical disease

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Danish Headache Center, Department of Neurology, Rigshospitalet

    Glostrup Municipality, 2600

  • Headache clinic, Department of Neurology, Odense University Hospital

    Odense, Odense, 5000

Other trials in Denmark

About this study

Official title: Glucagon-like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as Treatment of Idiopathic Intracranial Hypertension

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)

Read the 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.

Being tested
Semaglutide, Very Low Calorie Diet, Dietician counselling
Keywords
Idiopathic Intracranial Hypertension, Papilledema, Weight loss, Obesity, Pseudotumor Cerebri Syndrome, Intracranial Pressure
Medical subject headings
Pseudotumor Cerebri, Obesity, Papilledema, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Also called Ozempic, Wegovy

    Subcutaneous once-weekly injections of Semaglutide uptitrating to a maximum of 2.4 mg

  • Very Low Calorie DietDietary supplement

    Very Low Calorie Diet (max 800 kcal/day) using Nupo Diet meal replacement products

  • Dietician counsellingBehavioural

    Counselling by a dietician on weight loss through behavioural changes and life style intervention

Study groups in NCT06027567
Study groupRoleWhat they receive
SemaglutideExperimentalSemaglutide 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
Receives: Drug: Semaglutide; Dietary Supplement: Very Low Calorie Diet; Behavioral: Dietician counselling
Standard care (dietician)Active comparatorStandard weight loss intervention Counselling by dietician Standard medical treatment of intracranial hypertension
Receives: Behavioral: Dietician counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Weight change (%)

    Measured: 8 weeks

  2. Intracranial pressure

    Change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry

    Measured: 8 weeks

  3. Intracranial pressure

    Change in lumbar opening pressure (%)

    Measured: 8 weeks

Secondary outcomes (56)

  1. Weight

    Weight change (%)

    Measured: 10 months

  2. Intracranial Pressure

    Change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry

    Measured: 10 months

  3. Intracranial Pressure

    Change in lumbar opening pressure (%)

    Measured: 10 months

  4. 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)

    Measured: 8 weeks + 10 months

  5. 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

    Measured: 8 weeks + 10 months

  6. Change in Papilledema

    Change in Frisén Grade (0-5, 0 minimal, 5 worst)

    Measured: 8 weeks + 10 months

  7. Visual fields

    Perimetric mean deviation (decibel) by Humphrey automated perimetry

    Measured: 8 weeks + 10 months

  8. EDI-OCT

    Change in Papillary thickness (um) measured by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT)

    Measured: 8 weeks + 10 months

  9. Optic disc elevation

    Optic disc elevation (mm) measured by transorbital ultrasonography, (average of 3 scans of each eye with papilledema)

    Measured: Baseline + 8 weeks + 10 months

  10. Remission

    Proportion of patients with abscence of papilledema with or without intracranial pressure <25 cm cerebrospinal fluid

    Measured: 8 weeks + 10 months

  11. Change in fat mass

    Change in body fat percentage measured by Dual Energy X-ray Absorptiometry compared to baseline

    Measured: 8 weeks + 10 months

  12. Total fat mass

    Body fat percentage measured by Dual Energy X-ray Absorptiometry

    Measured: Baseline + 8 weeks + 10 months

  13. Feasibility

    Drop-out rate (proportion of patients withdrawing from participation)

    Measured: 8 weeks + 10 months

  14. Need of intracranial pressure-lowering medication_1

    Dose (mg) of intracranial pressure-lowering medication needed (Acetazolamide, Topiramate, diuretics)

    Measured: 8 weeks + 10 months

  15. 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

    Measured: Baseline + 8 weeks + 10 months

  16. Monthly headache days

    Number of days with headache for the past 30 days preceding visit

    Measured: Baseline + 8 weeks + 10 months

  17. Headche severity

    Number of days with mild, moderate, and severy headache, respectively, in the past 30 days preceding visit

    Measured: Baseline + 8 weeks + 10 months

  18. Headache medication - Acute analgesic use

    Number of days with need of acute analgesic treatment for headache

    Measured: Baseline + 8 weeks + 10 months

  19. Headache medication - preventive medication

    Need of preventive medical treatment for headache

    Measured: Baseline + 8 weeks + 10 months

  20. Optic nerve sheath diameter

    Optic nerve sheath diameter (mm) measured by transorbital ultrasonography (average of 3 scans of each eye with papilledema)

    Measured: Baseline + 8 weeks + 10 months

  21. 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

    Measured: Baseline + 8 weeks + 10 months

  22. Peripapillary artery-to-venule ratio

    Change in peripapillary artery-to-venule diameter ratio measured by confocal Scanning Laser Ophtalmoscopy

    Measured: Baseline + 8 weeks + 10 months

  23. Truncal fat

    Change in percentage of truncal adiposity measured by Dual Energy X-ray Absorptiometry

    Measured: Baseline + 8 weeks + 10 months

  24. Android-gynoid-ratio

    Change in ratio of Android versus gynoid fat percentage using Dual Energy X-ray Absorptiometry

    Measured: Baseline + 8 weeks and 10 months

  25. 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

    Measured: 8 weeks + 10 months

  26. Need of intracranial pressure-lowering medication_2

    Number of patients in need of any intracranial pressure-lowering drug (Acetazolamide, Topiramate, diuretics)

    Measured: Baseline + 8 weeks + 10 months

  27. Insulin like-Growth-Factor-1

    Level of Insulin like-Growth-Factor-1 in serum (ug/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  28. 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.

    Measured: Baseline

  29. Growth hormone

    Level of growth hormone in serum ug(L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  30. Lutropin

    Level of Lutropin in serum (IU/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  31. Follitropin

    Level of Follitropin in serum (IU/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  32. Testosteron

    Level of testosteron in serum (nmol/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  33. Estradiol

    Level of estradiol in serum (nmol/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  34. Sex-Hormone Binding Globulin

    Level of Sex-Hormone Binding Globulin in serum (nmol/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  35. Anti-Müllerian Hormone

    Level of Anti-Müllerian Hormone (pmol/L) in serum in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  36. Dehydroepiandrosterone

    Level of Dehydroepiandrosterone (DHEAS) in serum (umol/L) in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  37. Androstenedion

    Level of androstenedion (nmol/L) in serum in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  38. 17-hydroxyprogesterone (mg/d)

    Level of 17-hydroxyprogesterone (mg/d) in serum in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  39. Cortisol 0 min

    Level of cortisol (nmol/L) in serum in women not taking estrogen-containing contraceptives.

    Measured: Baseline

  40. 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.

    Measured: Baseline

  41. 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)

    Measured: Baseline + 8 weeks + 10 months

  42. Calcitonin Gene Related Peptide

    Calcitonin Gene Related Peptide (CGRP) level pg/mL (picograms per milliliter in plasma and cerebrospinal fluid)

    Measured: Baseline + 8 weeks + 10 months

  43. Change in bone marker (CTX)

    Change in carboxy-terminal collagen crosslinks (CTX) level (nanograms per liter)

    Measured: Baseline + 8 weeks + 10 months

  44. Change in bone marker (PiNP)

    Change in procollagen type I N-propeptide (PiNP) level (micrograms per liter) compared to baseline

    Measured: baseline + 8 weeks + 10 months

  45. 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

    Measured: Baseline + 8 weeks + 10 months

  46. Androgen metabolism_1

    Ratio between Etiocholanolone and Androsterone (ng/mg) in 24-hour urine

    Measured: Baseline + 8 weeks + 10 months

  47. Androgen metabolism_2

    Ratio between 5-alpha-tetrahydrocortisol (5a-THF) and tetrahydrocortisol (THF) in 24-hour urine

    Measured: Baseline + 8 weeks + 10 months

  48. Androgen metabolism_3

    Level of testosterone in 24-hour urine (ng/L)

    Measured: Baseline + 8 weeks + 10 months

  49. Androgen metabolism_4

    Level of 3-alpha-androstanediol in 24-hour urine (nmol/L)

    Measured: Baseline + 8 weeks + 10 months

  50. Androgen metabolism_5

    Level of 11-oxygenated androgens (11-OHA4) (pg/L) in 24-hour urine

    Measured: Baseline + 8 weeks + 10 months

  51. Intrathecal Semaglutide

    Level of semaglutide in cerebrospinal fluid (picomol/L)

    Measured: 10 months

  52. Ammoniaemia_1

    Levels of plasma ammonium (umol/L)

    Measured: Baseline + 8 weeks + 10 months

  53. Ammoniaemia_2

    Correlation between plasma ammonium (umol/L) and presence of fatty liver disease as indicated by liver ultrasonography

    Measured: Baseline + 8 weeks + 10 months

  54. Ketosis

    Proportion of patients in ketosis measured by urine stix

    Measured: 8 weeks + 10 months

  55. Change in metabolic parameters

    Change in Homeostatic Model for Insulin Resistance (HOMA2IR) compared to baseline

    Measured: 8 weeks + 10 months

  56. Change in metabolic parameters

    Change in glycated hemoglobin (mmol/mol) compared to baseline

    Measured: 8 weeks + 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start2 Sep 2022
  3. Primary completion28 Jan 2025
  4. Study completion28 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06027567
Sponsor's protocol ID
IIH:DUAL
Acronym
IIH:DUAL
Status last verified
Oct 2025
First submitted
23 Feb 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide, Very Low Calorie Diet and Dietician counselling in people with Idiopathic Intracranial Hypertension and Intracranial Pressure, run by Rigmor Højland Jensen at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06027567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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