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 (IIH:DUAL)

Rigmor Højland Jensen

Status and phase: Active, not recruiting; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06027567

IIH:DUAL

Details and patient eligibility

About

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)

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Semaglutide

Experimental group

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

Treatment:

Dietary Supplement: Very Low Calorie Diet

Drug: Semaglutide

Behavioral: Dietician counselling

Standard care (dietician)

Active Comparator group

Description:

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

Treatment:

Behavioral: Dietician counselling