TOPAZNCT07734792

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

StatusRecruiting

PhasePhase 2/3

Sponsoryifang zhu

Primary completionMay 31, 2028 (estimated)

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 6, 2026 Recruitment opened
- Eligibility criteria shortened, about 8 words
- Start date changed from estimate of Sep 20, 2026 to Sep 26, 2026
- Site details revised
Notable Sep 27, 2026 Enrollment increased: 430 → 726 participants Show 4 more changesShow less
- Start date: Aug 10, 2026 to Sep 20, 2026
- Eligibility criteria shortened, about 3 words
- Secondary endpoints: details revised at 1 of 3 entries
- Publications: details revised at 19 of 19 entries
Jul 24, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

The primary efficacy outcome: Proportion of patients achieving an excellent functional outcome

Timeframe: 90 ± 7 days after randomization

The primary safety outcome: All-cause mortality

Timeframe: 90 ± 7 days

Secondary (3)

The secondary efficacy outcome: Distribution of mRS scores at 90 days after randomization

The secondary efficacy outcome: Proportion of patients achieving an good functional outcome

The secondary safety outcome: Symptomatic intracranial hemorrhage (sICH)

Arms and interventions

Tirzepatide Intervention GroupExperimental

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

Control GroupActive comparator

Participants will receive EVT and standard medical care without tirzepatide.

Drugs: Tirzepatide

Other: Standard Medical Care (SMC)

Sites

1 site in 1 country

The Second Afliated Hospital of SooChow UniversitySuzhou, Jiangsu, China

About this trial

Acute ischemic stroke caused by blockage of a large artery in the brain is one of the leading causes of death and long-term disability worldwide. 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. This study aims to evaluate whether tirzepatide, a medication that activates both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) pathways, can improve recovery in patients with acute ischemic stroke caused by large vessel occlusion who receive thrombectomy. Tirzepatide is currently approved for the treatment of conditions such as type 2 diabetes and obesity. Previous studies have shown that tirzepatide can improve blood sugar control, reduce body weight, and provide beneficial effects on cardiovascular health. Laboratory studies and early clinical evidence suggest that medications targeting GLP-1 and GIP pathways may also have protective effects on the brain by reducing inflammation, protecting brain cells, improving blood vessel function, and supporting recovery after stroke. In this study, eligible patients with acute ischemic stroke caused by blockage of a major brain artery will be randomly assigned to receive either tirzepatide plus standard stroke care or standard stroke care alone. Participants will receive two subcutaneous injections of tirzepatide: the first dose before the thrombectomy procedure and the second dose 7 days after the procedure. The study will include multiple hospitals and will use independent assessment of outcomes to ensure reliable evaluation of treatment effects. The primary purpose of this study is to determine whether early treatment with tirzepatide can improve functional recovery 90 days after stroke, measured by the patient's ability to perform daily activities and live independently. The study will also evaluate whether tirzepatide is safe in patients with acute ischemic stroke by monitoring adverse events, complications, and other clinical outcomes. The findings from this study may provide important evidence for a new treatment approach to improve recovery after thrombectomy and reduce disability among patients with severe ischemic stroke.

Trial details

Enrollment: 726 participants (estimated)
Started: Sep 26, 2026
Study completion: Jul 31, 2028 (estimated)
Eligibility: 19 to 80, all sexes, no healthy volunteers
Design: Interventional, randomized, single blind, treatment
Oversight: Data monitoring committee
Conditions: Ischemic Stroke, Acute Ischemic Stroke (AIS)
Official title: Effect of Tirzepatide on Functional Outcomes in Patients With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy: A Multicenter, Randomized, Controlled, Blinded Outcome Assessment Trial
First posted: Jul 29, 2026
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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