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

NCT ID: NCT06027567

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2025-10-30

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.

Conditions

Idiopathic Intracranial Hypertension; Intracranial Pressure; Obesity; Pseudotumor Cerebri Syndrome; Papilledema; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Semaglutide

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

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

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

Very Low Calorie Diet

Intervention Type: DIETARY_SUPPLEMENT

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

Dietician counselling

Intervention Type: BEHAVIORAL

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

Standard care (dietician)

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

Group Type: ACTIVE_COMPARATOR

Dietician counselling

Intervention Type: BEHAVIORAL

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

Interventions

Semaglutide

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

Intervention Type: DRUG

Very Low Calorie Diet

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

Intervention Type: DIETARY_SUPPLEMENT

Dietician counselling

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Ozempic, Wegovy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigmor Højland Jensen

OTHER

Sponsor Role: lead

Responsible Party

Rigmor Højland Jensen

Professor in Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rigmor H Jensen, Professor

Role: STUDY_DIRECTOR

Danish Headache Center

Locations

Headache clinic, Department of Neurology, Odense University Hospital

Odense, Odense, Denmark

Danish Headache Center, Department of Neurology, Rigshospitalet

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

IIH:DUAL

Identifier Type: -

Identifier Source: org_study_id