Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

Phase 3Not Yet RecruitingNCT06361823

Capital Medical University74 enrolled

Overview

This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.

Idiopathic intracranial hypertension (IIH) is a condition characterized by elevated pressure within the skull for reasons that are not yet understood. This condition does not involve abnormalities in the cerebrospinal fluid or any structural brain damage. Individuals with this condition commonly experience persistent headaches, and some may face the potential of irreversible vision loss, significantly impacting their psychological well-being and overall quality of life. At present, the efficacy of medications like acetazolamide and topiramate in managing IIH is constrained by practical clinical constraints. Recent studies have indicated that glucagon-like peptide-1 receptor agonists show promise as a potential treatment option for IIH. Semaglutide, as a long-acting glucagon-like peptide-1 formulation, has a half-life of up to 160 hours and only needs to be injected once a week. It is easy to administer and has good safety and tolerability. Hence, the objective of this study is to investigate the effectiveness and safety of semaglutide in managing idiopathic intracranial hypertension, laying the groundwork for subsequent extensive, multicenter research endeavors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Intracranial Hypertension

Interventions

SemaglutideDRUG

Giving Semaglutide via subcutaneous injections on a weekly basis for a duration of 3 months. The dosage is 0.25 mg for the initial month, then upped to 0.5 mg for patients who could handle it in the second month, and eventually escalated to 1.0 mg for patients who continued to tolerate it in the third month.

Low calorie dietDIETARY_SUPPLEMENT

Low calorie diet (max 1200 kcal/day)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Intracranial pressure

The intracranial pressure is represented by the cerebrospinal fluid pressure measured by lumbar puncture in a lateral position.

Time frame: 12 weeks

Adverse reactions

Adverse reactions include gastrointestinal reactions (such as nausea, vomiting, diarrhea), hypoglycemia, allergic reactions (such as rapid allergic reactions, vascular edema).

Time frame: 12 weeks

Secondary Outcomes

Headache severity

It is measured by the questionnaire "Headache Impact Test-6" (HIT-6); score range is 36-78. The higher the score, the more severe the headache.