Tirzepatide in Idiopathic Intracranial Hypertension Trial

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.

NCT Number	NCT07191873
Lead Sponsor	Duke University Collaborators: Eli Lilly and Company
Conditions	Idiopathic Intracranial Hypertension (IIH)
Enrollment	60 participants
Start Date	2026-08
Primary Completion	2027-08 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-28