A Trial to Determine the Efficacy and Safety of Presendin in IIH

NCT05347147 · Terminated

Last updated 2026-05-28

This clinical trial is testing the drug Presendin in adults with idiopathic intracranial hypertension to see how it affects pressure in the brain over 24 weeks.

Status Terminated Stopped early and will not restart.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 14 people

Who can join Ages 18+ · all sexes

Timeline Started 2022-11 · est. completion 2023-10

Where 24 sites · Australia, Germany, Israel, New Zealand, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT05347147 ↗

Description as written by the study sponsor.

Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.

Treatments tested

Presendin Drug

Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
Placebo Drug

Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.

Main thing measured	Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Sponsor	Invex Therapeutics Ltd.
Conditions studied	Idiopathic Intracranial Hypertension
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05347147 ↗