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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Intracranial Hypertension
• Intervention / Treatment: Drug: Semaglutide; Dietary supplement: Low calorie diet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xunming Ji, MD PhD; Phone Number: +86-83198952; Email: jixunming@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide; 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.	Drug: Semaglutide; 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.; Other Names: Ozempic; Dietary supplement: Low calorie diet; Low calorie diet (max 1200 kcal/day)
Active Comparator: Usual treatment; Usual treatment refers to the 2018 consensus guidelines on the management of IIH.	Dietary supplement: Low calorie diet; Low calorie diet (max 1200 kcal/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial pressure	The intracranial pressure is represented by the cerebrospinal fluid pressure measured by lumbar puncture in a lateral position.	12 weeks
Adverse reactions	Adverse reactions include gastrointestinal reactions (such as nausea, vomiting, diarrhea), hypoglycemia, allergic reactions (such as rapid allergic reactions, vascular edema).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline + 12 weeks
Degree of papilledema	It is represented by the Frisén Grade (0-5, 0 is the minimal, 5 is the worst) measured by fundoscope.	Baseline + 12 weeks
Perimetric mean deviation	It is measured by Humphrey automated perimetry.	Baseline + 12 weeks
Optic nerve sheath diameter	It is measured by optic nerve sheath ultrasound.	Baseline + 12 weeks
Body mass index	Change in body mass index.	Baseline + 12 weeks

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension; Pseudotumor Cerebri; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: IIH-Semaglutide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No