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NCT07191873 · ClinicalTrials.gov registry record · Phase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
A Phase 4 study, sponsored by Duke University.
- Not yet
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT07191873: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT07191873 is a Phase 4 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07191873, a Phase 4 study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.
Interventions
- DRUG Tirzepatide
- DRUG Tirzepatide Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-02 |
| Est. Completion | 2028-02 |
| Phase | Phase 4 |
What is known before NCT07191873 opens enrollment
NCT07191873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Tirzepatide is the first listed.
NCT07191873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07191873 about?
NCT07191873 is a clinical study titled "Tirzepatide in Idiopathic Intracranial Hypertension Trial". 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 Pla...
What is the current status of trial NCT07191873?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2026-02. Estimated completion is 2028-02.
What interventions are being tested in trial NCT07191873?
The interventions under investigation include: Tirzepatide (DRUG), Tirzepatide Placebo (DRUG).
Who is sponsoring clinical trial NCT07191873?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07191873's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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