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

Sponsor
Capital Medical University
Study ID
NCT06361823
Phase
PHASE3
Status
Unknown

Conditions

  • Idiopathic Intracranial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • Low calorie diet — DIETARY_SUPPLEMENT
    Low calorie diet (max 1200 kcal/day)

Study Details

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

Key Dates

Start date
May 1, 2024
Status verified
Apr 2024
Primary completion
Dec 1, 2024
Completion
Jan 1, 2025

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Usual treatment
    Usual treatment refers to the 2018 consensus guidelines on the management of IIH.

Primary Outcome Measure

Intracranial pressure [ Time Frame: 12 weeks ]

Central Contacts