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Not yet recruitingPhase 2Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
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
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
100
estimated
Study population
Stroke
Key I/E criterion
—
Primary endpoint
•Feasibility - Recruitment
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age 18 years or above on the date of randomization.
2. 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).
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points at the time of randomization.
4. Pre-stroke modified Rankin Scale (mRS) 0 or 1.
5. Ability to randomize within 6 hours from the end of EVT.
6. Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR).
Exclusion criteria
1. Pregnancy or breast-feeding.
2. Renal insufficiency (creatinine clearance < 30mL/min).
3. Cirrhosis or severe hepatic dysfunction, characterized by jaundice, encephalopathy or coagulopathy.
4. History of pancreatitis in the year prior to randomization or evidence of acute pancreatitis on randomization.
5. Active sepsis on randomization.
6. 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.
7. Any terminal medical condition with life expectancy of less than 3 months.
8. Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).
9. Body mass index (BMI) less than 19.
10. Known hypersensitivity to GLP-1 RAs.
11. Active treatment with an GLP-1RA prior to randomization.
12. Refusal or inability to administer subcutaneous (SC) injections by the patient or a caregiver.
13. Close affiliation with the investigational site.
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
3 endpointsExploratory Outcome
Time frame:Randomization and 36±12 hours
change from baseline, improvement
Exploratory Outcome
Time frame:Randomization to day 90±14
Stroke (any)
event count, event
SNOMED 230690007
Exploratory Outcome
Time frame:Randomization to day 90±14
3-point MACE
composite event, event
componentsStroke (any), Myocardial infarction (any), Cardiovascular death
Patient-reported / QoL
1 endpointExploratory Outcome
Time frame:At day 90±14
EQ-5D index
descriptive, improvement
Other clinical outcomes
8 endpointsFeasibility - Medication Adherence
Time frame:From randomization to day 90±14
threshold achievement, descriptive
Feasibility - Retention Rate
Time frame:From randomization to day 90±14
threshold achievement, descriptive
Exploratory Outcome
Time frame:At day 90±14
threshold achievement, improvement
Exploratory Outcome
Time frame:At day 7±2
descriptive
Exploratory Outcome
Time frame:At day 7±2
threshold achievement, improvement
Exploratory Outcome
Time frame:At day 30±7
categorical status, improvement
Exploratory Outcome
Time frame:At day 30±7
threshold achievement, improvement
Exploratory Outcome
Time frame:At day 90±14
descriptive, improvement
Other (unclassified)
1 endpointFeasibility - Recruitment
Time frame:From site activation until the end of recruitment (approximately 24 months)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.