Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy

NCT07511543 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: LEAST
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endovascular thrombectomy (EVT) is a procedure that improves recovery for people who suffer from a stroke by removing blood clots from large blood vessels in the brain. However, even with this treatment, over half of the patients either pass away or are left with serious disabilities within three months. This is partly because, even in cases of a successful EVT, brain tissue damage continues to grow. Extent of brain damage is a major factor in how well a patient recovers. Studies in animals have shown that a drug called semaglutide might help protect the brain and improve recovery after a stroke. Semaglutide is currently used for the treatment of diabetes and obesity and is given as a weekly injection under the skin. The investigators are hoping to test whether giving semaglutide to stroke patients undergoing EVT can improve their recovery. A very large study at many hospitals is needed to answer this question. The investigators are starting with a smaller study to gain information on whether it is possible to perform a larger definitive one, and if so, how best to plan for it. In this first step the investigators will study 100 patients with stroke who are scheduled for EVT in approximately 10 stroke centers across Canada. These patients will be randomly divided (like flipping a coin) into two groups: one will receive weekly semaglutide injections for 12 weeks, while the other will not receive the drug. The investigators will track how many patients agree to participate, how many stay in the study, and how well they follow the treatment plan. The investigators will also monitor the patients' recovery, overall health, and any side effects from the treatment. These results will provide important information to plan the larger study with the goal of reducing death rates and long-term disability in stroke patients undergoing EVT.

Conditions

Ischemic Stroke

Keywords

semaglutide; stroke; endovascular thrombectomy; large vessel occlusion; glucagon-like peptide-1 receptor agonist; GLP-1 RA

Outcome Measures

Primary Outcomes (1)

• Feasibility - Recruitment

  Recruitment of approximately 10 patients per site per year at approximately 10 Canadian stroke centres

  From site activation until the end of recruitment (approximately 24 months)

Secondary Outcomes (2)

• Feasibility - Medication Adherence

  From randomization to day 90±14

• Feasibility - Retention Rate

  From randomization to day 90±14

Other Outcomes (10)

• Exploratory Outcome

  At day 90±14

• Exploratory Outcome

  Randomization and 36±12 hours

• Exploratory Outcome

  At day 7±2

Study Arms (2)

Semaglutide

EXPERIMENTAL

Semaglutide

Drug: Semaglutide

No Intervention

NO INTERVENTION

No Intervention

Interventions

Semaglutide DRUG

Glucagon-like peptide-1 (GLP-1) receptor agonist

Also known as: Ozempic

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above on the date of randomization.
• EVT for an LVO in the anterior circulation, defined as the intracranial segment of the internal carotid artery (ICA) and/or the M1 or proximal M2 segment of the middle cerebral artery (MCA).
• National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points at the time of randomization.
• Pre-stroke modified Rankin Scale (mRS) 0 or 1.
• Ability to randomize within 6 hours from the end of EVT.
• Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR).

You may not qualify if:

• Pregnancy or breast-feeding.
• Renal insufficiency (creatinine clearance \< 30mL/min).
• Cirrhosis or severe hepatic dysfunction, characterized by jaundice, encephalopathy or coagulopathy.
• History of pancreatitis in the year prior to randomization or evidence of acute pancreatitis on randomization.
• Active sepsis on randomization.
• Cancer, regionally advanced or metastatic, or for which treatment had been administered within 6 months from randomization, or hematological cancer that is not in complete remission.
• Any terminal medical condition with life expectancy of less than 3 months.
• Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).
• Body mass index (BMI) less than 19.
• Known hypersensitivity to GLP-1 RAs.
• Active treatment with an GLP-1RA prior to randomization.
• Refusal or inability to administer subcutaneous (SC) injections by the patient or a caregiver.
• Close affiliation with the investigational site.

Sponsors & Collaborators

• Population Health Research Institute: lead

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aristeidis Katsanos, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Mike Sharma, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Ashkan Shoamanesh, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodi Miller, PhD

CONTACT

905-521-2100; least@phri.ca

Amanda Taylor

CONTACT

905-521-2100; least@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share