Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial

What Was Tested

This registered phase 2, phase 3 trial tested Tirzepatide.

For patients with this type of stroke, endovascular thrombectomy (EVT), a procedure that removes the blood clot and restores blood flow to the brain, has become the standard treatment.

However, even when blood flow is successfully restored, many patients continue to experience disability because of ongoing brain injury caused by inflammation, oxidative stress, and damage to brain cells after the stroke.

It had two arms (groups): Tirzepatide Intervention Group (experimental) and Control Group (active comparator).

Participants will receive two subcutaneous injections of tirzepatide: the first administered before EVT and the second administered 7 days after EVT, in addition to standard medical care.

Participants will receive EVT and standard medical care without tirzepatide.

The registry classes the interventions as drug and other.

More on the Plan

Patients with concomitant large vessel occlusion (LVO) experience the most severe neurological deficits.

The DAWN and DEFUSE 3 trials further extended the EVT treatment window to 24 hours after symptom onset.

Consequently, EVT has received the highest level of recommendation in international stroke guidelines.

Nearly half of patients remain severely disabled or die despite successful recanalization.

Who Took Part

726 planned participants were the target.

It was open to people of any sex aged from 19 years up to 80 years.

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

Examples of who could join: Age \>18 years and ≤80 years;. Acute ischemic stroke with imaging-confirmed anterior large vessel occlusion at:. M1 segment of the middle cerebral artery, or. Dominant M2 segment;. NIHSS score between 6 and 25 prior to randomization;.

The full record lists 11 inclusion and 21 exclusion criteria; among the exclusions: posterior-circulation large vessel occlusion stroke;; receipt of intravenous thrombolysis prior to randomization;; simultaneous bilateral anterior-circulation occlusions or concurrent anterior- and posterior-circulation occlusions;.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Tirzepatide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-09-20 with completion listed for 2028-05-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The primary safety outcome: All-cause mortality (time frame: 90 ± 7 days).

It also tracked 3 secondary outcomes, for example The secondary safety outcome: Symptomatic intracranial hemorrhage (sICH).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Tirzepatide in 726 people.

With 726 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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