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

NCT06361823 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IIH-Semaglutide
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Headache severity

  Baseline + 12 weeks

• Degree of papilledema

  Baseline + 12 weeks

• Perimetric mean deviation

  Baseline + 12 weeks

• Optic nerve sheath diameter

  Baseline + 12 weeks

• Body mass index

  Baseline + 12 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

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; Dietary Supplement: Low calorie diet

Usual treatment

ACTIVE COMPARATOR

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

Dietary Supplement: Low calorie diet

Interventions

Semaglutide 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.

Also known as: Ozempic

Semaglutide

Low calorie diet DIETARY_SUPPLEMENT

Low calorie diet (max 1200 kcal/day)

Semaglutide; Usual treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

semaglutide; Caloric Restriction

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Xunming Ji, MD PhD

CONTACT

+86-83198952; jixunming@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner.

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share