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

NCT06027567 | Completed Phase 4 DMC

• 1 other identifier: IIH:DUAL
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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)

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Weight

  Weight change (%)

  8 weeks

• Intracranial pressure

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

  8 weeks

• Intracranial pressure

  Change in lumbar opening pressure (%)

  8 weeks

Secondary Outcomes (56)

• Weight

  10 months

• Intracranial Pressure

  10 months

• Intracranial Pressure

  10 months

• Quality of Life

  8 weeks + 10 months

• Headache burden measured by HURT questionnaire

  8 weeks + 10 months

Other Outcomes (1)

• Omics

  Baseline + 8 weeks + 10 months

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: Semaglutide; Dietary Supplement: Very Low Calorie Diet; Behavioral: Dietician counselling

Standard care (dietician)

ACTIVE COMPARATOR

Standard weight loss intervention Counselling by dietician Standard medical treatment of intracranial hypertension

Behavioral: Dietician counselling

Interventions

Semaglutide DRUG

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

Also known as: Ozempic, Wegovy

Semaglutide

Very Low Calorie Diet DIETARY_SUPPLEMENT

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

Semaglutide

Dietician counselling BEHAVIORAL

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

Semaglutide; Standard care (dietician)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigmor Højland Jensen: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Headache clinic, Department of Neurology, Odense University Hospital

Odense, Odense, 5000, Denmark

Location

Danish Headache Center, Department of Neurology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Pseudotumor Cerebri; Obesity; Papilledema; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Body Weight Changes

Study Officials

• Rigmor H Jensen, Professor

  Danish Headache Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Neurology

Model Details: Open label randomized controlled clinical treatment trial Patients are randomly assigned 1:1 to standard-of-care or intervention

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: September 7, 2023
• Study Start: September 2, 2022
• Primary Completion: January 28, 2025
• Study Completion: October 28, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)