Tirzepatide in Idiopathic Intracranial Hypertension Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDuke University
About this 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 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.
Eligibility criteria
Qualifiers
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;
elevated lumbar puncture (LP) opening pressure (OP) ≥25 cm H2O in lateral decubitus position with legs extended (>= (≥ 20cm H2O if one of the following is present: pulse synchronous tinnitus, abducens palsy, Frisen grade II papilledema, transverse venous sinus stenosis, partially empty sella or enlarged optic nerve sheath on magnetic resonance imaging (MRI);
Disqualifiers
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
History of pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), history of gallbladder disease, ulcerative colitis, Crohn's disease, or history of hypersensitivity reaction in response to the drug
Trial design
Treatments tested in this trial
- Tirzepatide
- Tirzepatide Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov