NCT07191873

Tirzepatide in Idiopathic Intracranial Hypertension Trial

A Phase IV Placebo-controlled Single Center Trial for Tirzepatide in Idiopathic Intracranial Hypertension Trial (TIIHT)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Idiopathic Intracranial Hypertension (IIH)

Interventions

Type	Name	Description
DRUG	Tirzepatide	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
DRUG	Tirzepatide Placebo	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

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2025-09-25
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study