Tirzepatide in Idiopathic Intracranial Hypertension Trial

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

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.

It had two arms (groups): Tirzepatide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Headaches, tinnitus, visual obscurations, papilledema;. Absence of localizing findings on neurological examination (except for VI nerve palsy);. No secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion;. The patient is awake and alert. BMI ≥30 kg/m2.

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: previous bariatric surgery; prior intervention for high icp including optic nerve sheath fenestration (onsf), venous stenting and/or shunting; taking another glp-1 agonist, another drug that can interfere with the glp-1 agonist, or any other anti-obesity medication.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-08-25 with completion listed for 2027-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients (time frame: From enrollment to end of treatment at 12 months).

It also tracked 3 secondary outcomes, for example Retinal Nerve Fiber Layer (RNFL) Thickness on optical coherence tomograhy (OCT), Change in Frisen papilledema grade on fundus photography and Change in perimetric mean deviation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.