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

IIH:DUAL

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)

2022-09-02

2025-03-31

2025-12-31

Recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label randomized controlled clinical treatment trial Patients are randomly assigned 1:1 to standard-of-care or intervention', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-09-11