Tirzepatide in Idiopathic Intracranial Hypertension Trial

NCT07191873 · Not yet recruiting

Last updated 2026-05-28

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

Status Not yet recruiting Approved but enrollment has not started.

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 2026-02 · est. completion 2028-02

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

Tirzepatide Drug

Dosage Treatment time 2.5mg/0.5mL: 4 Weeks 5mg/0.5mL: 4 Weeks 7.5mg/0.5mL: 4 Weeks 10mg/0.5mL: 4 Weeks 12.5mg/0.5mL: 4 weeks 15mg/0.5 mL: 7 Months
Tirzepatide Placebo Drug

Dosage Treatment time 2.5mg/0.5mL: 4 Weeks 5mg/0.5mL: 4 Weeks 7.5mg/0.5mL: 4 Weeks 10mg/0.5mL: 4 Weeks 12.5mg/0.5mL: 4 weeks 15mg/0.5 mL: 7 Months

Main thing measured	Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Sponsor	Duke University
Conditions studied	Idiopathic Intracranial Hypertension (IIH)
GLP-1 drugs	tirzepatide

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