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Tirzepatide in Idiopathic Intracranial Hypertension Trial

Study acronym: TIIHT
StatusRecruiting
PhasePhase 4
Started2026-08-25
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Feb 2027 → Aug 2027
See other at-risk trials from Duke University

Amendment history

2026-08-26
Study Status, Contacts/Locations v3
Recruitment opened
Start dateestimated 2026-08→confirmed 2026-08-25
Study sitesdetails revised at 1 of 1 site
2026-07-27
Study Status v2
Primary completion pushed: 2027-02 → 2027-08
Completion pushed: 2028-02 → 2028-08
Start date2026-02→2026-08
2025-11-12
Study Status v1
Primary completion date2027-07→2027-02
Completion date2027-09→2028-02
Start date2025-09→2026-02
2025-09-17
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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.
Trial Details
NCT Number NCT07191873
Lead Sponsor Duke University
Collaborators: Eli Lilly and Company
Conditions Idiopathic Intracranial Hypertension (IIH)
Enrollment 60 participants
Start Date 2026-08-25
Primary Completion 2027-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-15