Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: cardiovascular, other_emerging
- Who it enrolls
- age 18 Years to 75 Years; excludes diabetes; no BMI minimum stated; conditions: Idiopathic Intracranial Hypertension
- Interventions
- Semaglutide; Low calorie diet
- Conditions
- Idiopathic Intracranial Hypertension
- Phase and size
- Phase 3 · 74 participants
- Dates
- Start 2024-05-01
Primary completion 2024-12-01 - Sponsor
- Capital Medical University (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Intracranial pressure12 weeks
- Adverse reactions12 weeks
02Eligibility
Who can take part
Inclusion Criteria: * Age range from 18 to 75 years old, both male and female. * Confirmed definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria. * Voluntarily sign a written informed consent form. Exclusion Criteria: * Pregnant or breastfeeding women. * Currently using any hypoglycemic drugs, including glucagon like peptide-1 receptor agonists. * Known to be allergic to the active ingredients or any excipients in Semaglutide. * History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasias (MEN1/MEN2). * Diabetes, ketoacidosis, severe gastrointestinal diseases, pancreatitis, severe heart failure. * Vision loss caused by other diseases, such as diabetes retinopathy, iritis, cataract, etc. * Malignant IIH with vision at risk necessitating surgical intervention. * Unable to cooperate in completing imaging examinations. * History of bariatric surgery or cerebrospinal fluid diversion. * Have used any drugs known to increase intracranial pressure within the past 3 months (including vitamin A, tetracycline drugs, lithium, etc). * Have participated in other clinical trials within the past 3 months, or did not withdraw from other clinical trials at the time of signing the informed consent form. * Other situations determined by the researcher that may pose a threat to the patients' life safety or may have an impact on the study.
03Change log
Registry changes
No changes recorded since the trial was added.