Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies

What Was Tested

This registered phase 2 trial tested Semaglutide.

With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO.

It had two arms (groups): Semaglutide Group (active comparator) and Standard of care (no intervention).

Standard medical therapy.

The registry classes the interventions as drug.

More on the Plan

In this multicenter, randomized, open-label pilot study, investigator aims to recruit 140 patients with LVO strokes in the terminal internal carotid artery (ICA) or proximal middle cerebral artery (MCA) who were eligible for EVT with a last-known-well (LKW) to puncture ≤ 12 hours.

Patients will be randomized in a 1:1 ratio to semaglutide or standard therapy.

Patients in the semaglutide group will receive the medication on the day of (D0) and 1 week (D7) after EVT.

Interval imaging and blood tests will be arranged to ascertain the degree of BBB leakage, final infarct size, inflammation and gene expression pre and post treatment.

Who Took Part

140 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: LVO stroke at terminal ICA or proximal M1 eligible for emergency endovascular treatment as per current treatment guideline. LKW-to-puncture time ≤ 12 hours. Age 18 years or greater. National Institute of Health Stroke Scale (NIHSS) ≥10. LVO stroke due to thromboembolism or intracranial stenosis (acute or acute on chronic occlusion).

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: ASPECT score ≤ 5; intracranial hemorrhage on pre-evt imaging; estimated or known body mass index \< 18 kg/m2.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2023-08-01 with completion listed for 2024-10-25.

It ran at 2 sites in China (1) and Hong Kong (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of Modified Rankin Score (time frame: Day 90). Composite Safety Outcome (time frame: Day 90).

It also tracked 9 secondary outcomes, for example Malignant brain edema (MBE), Symptomatic intracranial hemorrhage (sICH), Blood-brain-barrier (BBB) permeability, Hemorrhagic transformation and parenchymal hemorrhage, Modified Rankin Score (mRS) 0-3 and Modified Rankin Score (mRS) 0-1.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 140 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.