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

Capital Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Idiopathic Intracranial Hypertension

Treatments: Drug: Semaglutide; Dietary Supplement: Low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06361823

IIH-Semaglutide

Details and patient eligibility

About

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

Full description

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 2 patient groups

Semaglutide

Experimental group

Description:

Expanding on the usual treatment regimen, Semaglutide is administered through a subcutaneous injection once weekly over a period of 3 months. Initially, the dose is 0.25 mg for the first month, then increased to 0.5 mg for patients who could tolerate it in the second month, and finally raised to 1.0 mg for patients who still tolerated it in the third month.

Treatment:

Dietary Supplement: Low calorie diet

Drug: Semaglutide

Usual treatment

Active Comparator group

Description:

Usual treatment refers to the 2018 consensus guidelines on the management of IIH.

Treatment:

Dietary Supplement: Low calorie diet