GLPwatch

Tirzepatide in Idiopathic Intracranial Hypertension Trial

NCT07191873 · Recruiting

Last updated 2026-09-22

This clinical trial is testing the drug tirzepatide in adults with idiopathic intracranial hypertension to see how it affects their intracranial pressure.

Status Recruiting Currently enrolling participants.
Phase Phase 4 Monitors a drug already on the market.
Type Interventional (clinical trial)
Design Randomized, quadruple-blind treatment study
Participants 60 people Planned (estimated).
Who can join Ages 18–60 · all sexes
Timeline Started 2026-08 · est. completion 2028-08
Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT07191873 ↗

Description as written by the study sponsor.

This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline ICP as a covariate. This primary endpoint will use a significance level of 0.05 to declare significance.

Treatments tested

Main thing measuredChange in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
SponsorDuke University
Conditions studiedIdiopathic Intracranial Hypertension (IIH)
GLP-1 drugs tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07191873 ↗