Tirzepatide in Idiopathic Intracranial Hypertension Trial
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugDosage 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
Tirzepatide Placebo
DrugDosage 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TirzepatideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.
Time frame
From enrollment to end of treatment at 12 monthsSecondary outcomes
1
Retinal Nerve Fiber Layer (RNFL) Thickness on optical coherence tomograhy (OCT)
Mean change in RNFL thickness
Time frame
From enrollment to end of treatment at 12 months2
Change in Frisen papilledema grade on fundus photography
The Frisen scale ranges from 0 (normal optic disc) to 5 (severe degree of edema).
Time frame
From enrollment to the end of treatment at 12 months3
Change in perimetric mean deviation
Perimetric Mean Deviation (MD) is a key visual field index that represents the average point-by-point difference between a patient's visual field and the normal, age-matched expected visual field.
Time frame
From enrollment to end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov