Ischemic StrokePhase 2LEASTNCT07511543
Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
A Phase 2 study testing Semaglutide in people with Ischemic Stroke, run by Population Health Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Prospective, Randomized, Open-label, Blinded Endpoint, Pilot Clinical Trial Evaluating Subcutaneous Semaglutide in Patients With Acute Ischaemic Stroke Due to Anterior Circulation Large Vessel Occlusion Treated With Endovascular Thrombectomy
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 we 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 our larger study with the goal of reducing death rates and long-term disability in stroke patients undergoing EVT.
Read the detailed description
Background/Importance:
Endovascular thrombectomy (EVT) has substantially improved functional outcomes and decreased mortality in acute ischemic stroke patients with large vessel occlusions (LVOs). However, more than half of the patients die or have significant disability at 90 days after EVT. Studies suggest considerable infarct growth despite successful EVT and infarct volume predicts survival and functional outcome after EVT. There is an unmet need for interventions to reduce infarct growth and improve the functional outcomes of patients with an acute LVO who undergo EVT. Glucagon-Like Peptide-1 receptor agonists (GLP-1 RAs) have been suggested to decrease infarct growth and improve motor and sensory impairments in both diabetic and non-diabetic animal models of stroke. GLP-1 RAs also consistently decreased the risk of major adverse cardiovascular events (MACE), with the most profound effect in stroke prevention, in large-scale randomized clinical trials (RCTs) of patients with and without history of diabetes.
Research Aims:
The overall goal of this study is to test whether semaglutide can improve the functional outcomes of adults with acute ischemic stroke attributed to an intracranial LVO who are planned for treatment with EVT. We are performing a pilot trial to obtain the factual feasibility prerequisites essential for the planning, design, funding and execution of a subsequent main phase trial.
Methods:
Glucagon-like peptide-1 receptor agonists for Endovascular Stroke Thrombectomy (LEAST) is a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) pilot clinical trial. LEAST will recruit a total of 100 adult patients scheduled to receive EVT at approximately 10 high-volume stroke research centres in Canada over 1.5 to 2 years. Participants fulfilling the inclusion and exclusion criteria will be randomly assigned up to 6 hours from the end of the EVT procedure, defined as the time of the last angiographic run, to either receive semaglutide (0.25 mg subcutaneous [SC] weekly for 4 weeks followed by 0.5 mg SC weekly for another 8 weeks) or to no semaglutide treatment.
Outcomes:
The primary feasibility endpoint is recruitment rate.
Secondary feasibility endpoints include retention rates and medication adherence.
Exploratory outcomes include:
Proportion of participants with functional independence (mRS scores 2 or less) at 90±14 days; Absolute difference in the NIHSS scores between randomization and 36±12 hours; Functional outcome at day 7±2, assessed with the ordinal mRS scores; Proportion of participants with functional independence (mRS scores 2 or less) at day 7±2; Functional outcome at day 30±7, assessed with the ordinal mRS scores; Proportion of participants with functional independence (mRS scores 2 or less) at day 30±7; Functional outcome at 90±14 days, assessed with the ordinal mRS scores; Quality of life at 90±14 days, assessed with the EQ-5D-5L scale; Recurrent stroke (ischemic, hemorrhagic or uncertain) by 90±14 days; Occurrence of MACE (any stroke, myocardial infarction cardiovascular death) by 90±14 days.
- Conditions
- Ischemic Stroke
- Being tested
- Semaglutide
- Keywords
- semaglutide, stroke, endovascular thrombectomy, large vessel occlusion, glucagon-like peptide-1 receptor agonist, GLP-1 RA
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic, Apo-semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Semaglutide Receives: Drug: Semaglutide |
| No Intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Recruitment of approximately 7 patients per site per year at approximately 10 Canadian stroke centres
Measured: From site activation until the end of recruitment (approximately 24 months)
Secondary outcomes (2)
Medication Adherence
Target >75% medication adherence
Measured: From randomization to day 90±14
Retention Rate
Target >90% of study participants remaining in the trial
Measured: From randomization to day 90±14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aristeidis Katsanos, MD, Principal investigator, Population Health Research InstituteMike Sharma, MD, Principal investigator, Population Health Research InstituteAshkan Shoamanesh, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511543
- Sponsor's protocol ID
- LEAST
- Acronym
- LEAST
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Randomized, Open-label, Blinded Endpoint, Pilot Clinical Trial Evaluating Subcutaneous Semaglutide in Patients With Acute Ischaemic Stroke Due to Anterior Circulation Large Vessel Occlusion Treated With Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT07511543
- Acronym / sponsor ID
- LEAST / LEAST
- Conditions
- Ischemic Stroke
- Keywords
- semaglutide, stroke, endovascular thrombectomy, large vessel occlusion, glucagon-like peptide-1 receptor agonist, GLP-1 RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 we 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 our larger study with the goal of reducing death rates and long-term disability in stroke patients undergoing EVT.
Detailed description
Background/Importance:
Endovascular thrombectomy (EVT) has substantially improved functional outcomes and decreased mortality in acute ischemic stroke patients with large vessel occlusions (LVOs). However, more than half of the patients die or have significant disability at 90 days after EVT. Studies suggest considerable infarct growth despite successful EVT and infarct volume predicts survival and functional outcome after EVT. There is an unmet need for interventions to reduce infarct growth and improve the functional outcomes of patients with an acute LVO who undergo EVT. Glucagon-Like Peptide-1 receptor agonists (GLP-1 RAs) have been suggested to decrease infarct growth and improve motor and sensory impairments in both diabetic and non-diabetic animal models of stroke. GLP-1 RAs also consistently decreased the risk of major adverse cardiovascular events (MACE), with the most profound effect in stroke prevention, in large-scale randomized clinical trials (RCTs) of patients with and without history of diabetes.
Research Aims:
The overall goal of this study is to test whether semaglutide can improve the functional outcomes of adults with acute ischemic stroke attributed to an intracranial LVO who are planned for treatment with EVT. We are performing a pilot trial to obtain the factual feasibility prerequisites essential for the planning, design, funding and execution of a subsequent main phase trial.
Methods:
Glucagon-like peptide-1 receptor agonists for Endovascular Stroke Thrombectomy (LEAST) is a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) pilot clinical trial. LEAST will recruit a total of 100 adult patients scheduled to receive EVT at approximately 10 high-volume stroke research centres in Canada over 1.5 to 2 years. Participants fulfilling the inclusion and exclusion criteria will be randomly assigned up to 6 hours from the end of the EVT procedure, defined as the time of the last angiographic run, to either receive semaglutide (0.25 mg subcutaneous [SC] weekly for 4 weeks followed by 0.5 mg SC weekly for another 8 weeks) or to no semaglutide treatment.
Outcomes:
The primary feasibility endpoint is recruitment rate.
Secondary feasibility endpoints include retention rates and medication adherence.
Exploratory outcomes include:
Proportion of participants with functional independence (mRS scores 2 or less) at 90±14 days; Absolute difference in the NIHSS scores between randomization and 36±12 hours; Functional outcome at day 7±2, assessed with the ordinal mRS scores; Proportion of participants with functional independence (mRS scores 2 or less) at day 7±2; Functional outcome at day 30±7, assessed with the ordinal mRS scores; Proportion of participants with functional independence (mRS scores 2 or less) at day 30±7; Functional outcome at 90±14 days, assessed with the ordinal mRS scores; Quality of life at 90±14 days, assessed with the EQ-5D-5L scale; Recurrent stroke (ischemic, hemorrhagic or uncertain) by 90±14 days; Occurrence of MACE (any stroke, myocardial infarction cardiovascular death) by 90±14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideSemaglutide |
| No Intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Ozempic, Apo-semaglutideGlucagon-like peptide-1 (GLP-1) receptor agonist | Drug | Semaglutide |
Primary outcome
Feasibility - Recruitment
Time frame: From site activation until the end of recruitment (approximately 24 months)
Recruitment of approximately 7 patients per site per year at approximately 10 Canadian stroke centres
2 secondary outcomes
Medication Adherence
Time frame: From randomization to day 90±14
Retention Rate
Time frame: From randomization to day 90±14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aristeidis Katsanos, MD principal investigator
Population Health Research Institute
Mike Sharma, MD principal investigator
Population Health Research Institute
Ashkan Shoamanesh, MD principal investigator
Population Health Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Ischemic Stroke, run by Population Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodi Miller, PhD (905-521-2100, leaststudy@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment (time frame: From site activation until the end of recruitment (approximately 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.