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

NCT ID: NCT06361823

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-01-01

Brief Summary

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

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.

Conditions

Idiopathic Intracranial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

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 diet

Intervention Type: DIETARY_SUPPLEMENT

Low calorie diet (max 1200 kcal/day)

Usual treatment

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

Group Type: ACTIVE_COMPARATOR

Low calorie diet

Intervention Type: DIETARY_SUPPLEMENT

Low calorie diet (max 1200 kcal/day)

Interventions

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.

Intervention Type: DRUG

Low calorie diet

Low calorie diet (max 1200 kcal/day)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ozempic

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xunming Ji, MD PhD

Role: CONTACT

jixunming@vip.163.com

+86-83198952

Other Identifiers

IIH-Semaglutide

Identifier Type: -

Identifier Source: org_study_id