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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Not Yet Recruiting PHASE4 INTERVENTIONAL NCT07191873

Tirzepatide in Idiopathic Intracranial Hypertension Trial

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Tirzepatide
Type: DRUG
Description: 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
Name: Tirzepatide Placebo
Type: DRUG
Description: 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

Primary Outcomes

Measure: Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
TimeFrame: From enrollment to end of treatment at 12 months
Description: Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.

Trial Information

NCT ID

NCT07191873

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Duke University

Last Updated

December 15, 2025