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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 is a Phase 4 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07191873
The ClinicalTrials.gov registry entry for NCT07191873 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tirzepatide is the first listed.
NCT07191873 reports 0 study locations.
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.
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