StrokePhase 2GALLOPNCT05920889
Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies
A Phase 2 study testing Semaglutide in people with Stroke and Stroke, Acute, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial summary
Endovascular thrombectomy (EVT) is a highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2023to 25 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVO stroke at terminal ICA or proximal M1 eligible for emergency endovascular treatment as per current treatment guideline.
- LKW-to-puncture time ≤ 12 hours.
- Age 18 years or greater.
- National Institute of Health Stroke Scale (NIHSS) ≥10
- LVO stroke due to thromboembolism or intracranial stenosis (acute or acute on chronic occlusion).
- Patients who received computer tomographic angiography and perfusion (CTA+P).
- Pre-stroke (24 hours prior to stroke onset) independent functional status with modified Rankin Scale (mRS) ≤ 2.
- Consent process completed as per national laws and regulation and the applicable ethics committee requirements.
Who cannot join
- ASPECT score ≤ 5.
- Intracranial hemorrhage on pre-EVT imaging.
- LVO etiologies other than thromboembolism or intracranial stenosis (acute or acute on chronic total occlusion), e.g. arterial dissection, infective endocarditis on initial diagnostic imaging.Estimated or known body mass index < 18 kg/m2
- Estimated or known body mass index < 18 kg/m2.
- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
- Creatinine clearance < 30mL/min.
Show all 15Show fewer
- Severe or fatal comorbid illness, e.g. terminal malignancy.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion.
- History of allergy to GLP-1RA.
- Family or personal history of multiple endocrine neoplasia, medullary thyroid carcinoma, pancreatic carcinoma, known proliferative diabetic retinopathy.
- Active sepsis on randomization.
- Patients with hypoglycaemia on presentation. Defined as capillary or serum glucose level of <4mmol/L.
- Patients prone to severe hypoglycaemia, including chronic kidney disease of estimated glomerular filtration rate of 50ml/min/1.73m^2; also those with chronic liver disease with Child's Pugh score C or above; patients with recurrent unexplained hypoglycemia.
- Patient already on GLP-1RA prior to screening.
- Contraindications to iodine-based CT contrast.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies - a Pilot Study
Endovascular thrombectomy (EVT) is a highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO. Nevertheless, more than half of LVO strokes suffered from functional dependence or death despite EVT. Futile EVTs were contributed by peri-procedural malignant brain edema (MBE) and symptomatic intracranial hemorrhage (sICH). Studies suggested that 26.9% of EVTs were complicated by MBE, whereas sICH was present in 6-9% of LVO patients who received EVT. The fundamental pathophysiology of MBE and sICH is blood-brain-barrier (BBB) disruption secondary to ischemia, mechanical and reperfusion injury. These pathological processes can result in increased tissue permeability, excess production of oxygen free radicals and inflammatory response that eventually lead to hemorrhage and edema. Poor collateral circulation, proximal LVOs, intravenous thrombolysis, blood pressure and glucose fluctuation had all been implicated to in MBE and sICH. However, these risk factors were either unmodifiable or not shown to improve EVT outcomes. The preliminary results of a recent randomized trial even suggested harmful effects of intensive blood pressure following EVT. With indications of EVT are expanding to patients with prolonged ischemia and large ischemic cores, enhancing BBB and neuronal tolerance to ischemia and reperfusion therapies may hugely impact on EVT outcomes. Recent animal models have shown that glucagon-like peptide peptide-1 receptor agonists (GLP-1RA) significantly reduced infarct volume and neurological deficits following temporary or permanent middle cerebral artery occlusion. These effects were likely due to the anti-oxidant, anti-inflammatory and anti-apoptotic properties of GLP-1RA that protected BBB integrity and ischemic neurons during induced LVO and/or reperfusion. Investigator hypothesizes that compared to standard reperfusion strategies, administration of GLP-1RA in LVO patients who receive EVT may prevent the development of MBE and sICH, and improve neurological outcomes. In this randomized, open-label pilot study, investigator aims to determine the effect of semaglutide, a GLP-1RA, on the radiological and clinical outcomes in LVO patients undergoing EVT.
Read the detailed description
In this multicenter, randomized, open-label pilot study, investigator aims to recruit 140 patients with LVO strokes in the terminal internal carotid artery (ICA) or proximal middle cerebral artery (MCA) who were eligible for EVT with a last-known-well (LKW) to puncture ≤ 12 hours. Patients will be randomized in a 1:1 ratio to semaglutide or standard therapy. Patients in the semaglutide group will receive the medication on the day of (D0) and 1 week (D7) after EVT. Interval imaging and blood tests will be arranged to ascertain the degree of BBB leakage, final infarct size, inflammation and gene expression pre and post treatment. Investigator shall recruit 40 patients from the Prince of Wales Hospital and 100 patients from Linyi People's Hospital.
Detailed study procedures are as follows:-
- LVO stroke patients will have received CTA and perfusion prior to screening.
- Informed consent from patient or next of kin will be obtained for eligible patients.
- After informed consent, patient will be randomized into semaglutide or standard treatment in a 1:1 ratio by computer-generated codes.
- Patients randomized into the semaglutide group will receive 0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. semaglutide group will receive a total of 2 injections.
- All study subjects will receive plain CT brain and perfusion D4-7 post EVT to look for MBE, sICH and hyperperfusion. Additional brain imaging may also be arranged as per clinical needs.
- All study subjects will receive a standardized stroke protocol MRI D14-21 after EVT for quantification of infarct volume.
- NIHSS before and immediately after, D3, D14-21, D90±7 post-EVT will be assessed.
- mRS before, D14-21, D90±7 post-EVT will be assessed.
- Blood test before and immediately, 3 days and 14 days after EVT (D0pre, D0post, D3, D14-21) will be collected for neurovascular inflammatory markers and transcriptomic analysis.
- Capillary blood glucose, blood pressure and pulse will be measured four times daily in accordance to the standardized post-EVT protocol during the first 5 days hospitalization. The frequency of monitoring may increase according to the clinical needs.
- The following data will be collected:
- Demographic data: date of birth, date of death (if applicable), smoking and drinking status
- Medical comorbidities: Hypertension, diabetes mellitus, hyperlipidemia, congestive heart failure, atrial fibrillation, ischemic heart disease, history of ischemic or hemorrhagic stroke, etc.
- Co-medications: Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, heparin, warfarin), antiplatelet agents (aspirin, clopidogrel, ticagrelor, cilostazol), lipid-lowering agents (simvastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin, ezetimibe, gemfibrozil, fenofibrate, erenumab), antihypertensive (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, calcium channel blockers, diuretics, aldosterone antagonists, nitrates, etc.), non-steroidal antiinflammatory agents or cyclo-oxygenase2 inhibitors (indomethacin, ibuprofen, diclofenac, celecoxib, etorixocib), glucose lowering drugs (metformin, gliclazide, glimepiride, empagliflozin, dapagliflozin, insulin).
- Routine blood tests including hemoglobin, white cell count, lymphocyte count, neutrophil count, creatinine, alanine transferase, alkaline phosphatase, bilirubin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglyceride, fasting glucose, glycated hemoglobin A1c, etc. These blood tests are part of routine clinical care pre- and post-stroke.
- Imaging data: ASPECT score, site of occlusion, collateral score, volume of infarct core, penumbra, mismatch volume and mismatch ratio.
- Stroke time metrics: LKW-to-hospital, -imaging, -needle, -puncture, -reperfusion time.
- EVT outcomes: modified thrombolysis in cerebral infarction (TICI) score.
- Occurrence of MBE, asymptomatic or symptomatic ICH, hemorrhagic transformation, subarachnoid hemorrhage (see Endpoint measurement for details).
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Brain Diseases
- Being tested
- Semaglutide
- Medical subject headings
- Stroke, Ischemic Stroke, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. patient will receive a total of 2 injections.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Group | Active comparator | Prescribe study drug: Patients randomized into the semaglutide group will receive 0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. semaglutide group will receive a total of 2 injections. Receives: Drug: Semaglutide |
| Standard of care | No intervention | Standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Modified Rankin Score
Change of Modified Rankin Score to measure degree of disability/dependence. Scores 0-2 is considered good outcome, while scores 3-6 is considered poor outcome.
Measured: Day 90
Composite Safety Outcome
Composite of Death, Intracranial Hemorrhage (ICH) and Malignant Brain Edema (MBE)
Measured: Day 90
Secondary outcomes (9)
Malignant brain edema (MBE)
Parenchymal hypodensity of at least 50% of the MCA territory and signs of local brain swelling such as sulcal effacement and compression of the lateral ventricle, and Midline shift of ≥5 mm at the septum pellucidum or pineal gland with obliteration of the basal cisterns.
Measured: From Day 0 post treatment, up to 90 Days.
Symptomatic intracranial hemorrhage (sICH)
Any parenchymal hemorrhage or hemorrhagic transformation temporally related to any worsening in neurological condition.
Measured: From Day 0 post treatment, up to 90 Days.
Blood-brain-barrier (BBB) permeability
Blood-brain-barrier permeability by CT perfusion scan
Measured: From Day 0 post treatment, up to 90 Days.
Hemorrhagic transformation and parenchymal hemorrhage
Hemorrhagic transformation and parenchymal hemorrhage as per Heidelberg Bleeding Classification,
Measured: From Day 0 post treatment, up to 90 Days.
Modified Rankin Score (mRS) 0-3
Modified Rankin Score 0-3 at 90 days
Measured: From Day 0 post treatment, up to 90 Days.
Modified Rankin Score (mRS) 0-1
Modified Rankin Score 0-1 at 90 days
Measured: From Day 0 post treatment, up to 90 Days.
Infarct size
Infarct size (mL) defined by brain magnetic resonance imaging segmentation
Measured: Day 14-21
Death
Mortality at 90 days
Measured: Day 90
Ordinal shift in Modified Rankin Score (mRS)
Shift in mRS at 90 days
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Aug 2023
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Model description
- 140 patients will be randomized to "treatment arm" with semaglutide and standard medical therapy, and "control arm" with standard medical therapy alone in a 1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Linyi People's Hospital
- Responsible party
- Principal investigator, Dr. IP Yiu Ming Bonaventure, Chinese University of Hong Kong
- Investigators
- Bonaventure Yiu Ming IP, MB ChB, Principal investigator, Chinese University of Hong KongFengyuan CHE, MD,PhD, Principal investigator, Linyi People's Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920889
- Sponsor's protocol ID
- CREC 2023.026-T
- Acronym
- GALLOP
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Ko H, Leung TW, Huang J, Sai J, Liang Y, Li H, Zhang J, Cao Q, Zang W, Li Y, Ma SH, Lui WT, Choi J, Chan C, Wong J, Kwok AJ, Ma K, Fan F, Chan A, Ip V, Leung H, Soo Y, Wong KT, Lai B, Chu CM, Leung HS, Hui A, Cheung T, Abrigo J, Li SH, Chan L, Yeung J, Pan S, Yip T, Lui LT, Hung T, Tsang SF, Leng X, Lam B, Mok VCT, Chan RHM, Nguyen TN, Hu W, Che F, Ip BY. Glucagon-like peptide-1 receptor agonist in large vessel occlusion treated by reperfusion therapy-a phase 2 randomized trial. Nat Commun. 2025 Dec 14;16(1):11274. doi: 10.1038/s41467-025-66167-z.
PubMed 41392086
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies - a Pilot Study
- ClinicalTrials.gov ID
- NCT05920889
- Acronym / sponsor ID
- GALLOP / CREC 2023.026-T
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Brain Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Linyi People's Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 27 Jun 2023 (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 highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO. Nevertheless, more than half of LVO strokes suffered from functional dependence or death despite EVT. Futile EVTs were contributed by peri-procedural malignant brain edema (MBE) and symptomatic intracranial hemorrhage (sICH). Studies suggested that 26.9% of EVTs were complicated by MBE, whereas sICH was present in 6-9% of LVO patients who received EVT. The fundamental pathophysiology of MBE and sICH is blood-brain-barrier (BBB) disruption secondary to ischemia, mechanical and reperfusion injury. These pathological processes can result in increased tissue permeability, excess production of oxygen free radicals and inflammatory response that eventually lead to hemorrhage and edema. Poor collateral circulation, proximal LVOs, intravenous thrombolysis, blood pressure and glucose fluctuation had all been implicated to in MBE and sICH. However, these risk factors were either unmodifiable or not shown to improve EVT outcomes. The preliminary results of a recent randomized trial even suggested harmful effects of intensive blood pressure following EVT. With indications of EVT are expanding to patients with prolonged ischemia and large ischemic cores, enhancing BBB and neuronal tolerance to ischemia and reperfusion therapies may hugely impact on EVT outcomes. Recent animal models have shown that glucagon-like peptide peptide-1 receptor agonists (GLP-1RA) significantly reduced infarct volume and neurological deficits following temporary or permanent middle cerebral artery occlusion. These effects were likely due to the anti-oxidant, anti-inflammatory and anti-apoptotic properties of GLP-1RA that protected BBB integrity and ischemic neurons during induced LVO and/or reperfusion. Investigator hypothesizes that compared to standard reperfusion strategies, administration of GLP-1RA in LVO patients who receive EVT may prevent the development of MBE and sICH, and improve neurological outcomes. In this randomized, open-label pilot study, investigator aims to determine the effect of semaglutide, a GLP-1RA, on the radiological and clinical outcomes in LVO patients undergoing EVT.
Detailed description
In this multicenter, randomized, open-label pilot study, investigator aims to recruit 140 patients with LVO strokes in the terminal internal carotid artery (ICA) or proximal middle cerebral artery (MCA) who were eligible for EVT with a last-known-well (LKW) to puncture ≤ 12 hours. Patients will be randomized in a 1:1 ratio to semaglutide or standard therapy. Patients in the semaglutide group will receive the medication on the day of (D0) and 1 week (D7) after EVT. Interval imaging and blood tests will be arranged to ascertain the degree of BBB leakage, final infarct size, inflammation and gene expression pre and post treatment. Investigator shall recruit 40 patients from the Prince of Wales Hospital and 100 patients from Linyi People's Hospital.
Detailed study procedures are as follows:-
- LVO stroke patients will have received CTA and perfusion prior to screening.
- Informed consent from patient or next of kin will be obtained for eligible patients.
- After informed consent, patient will be randomized into semaglutide or standard treatment in a 1:1 ratio by computer-generated codes.
- Patients randomized into the semaglutide group will receive 0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. semaglutide group will receive a total of 2 injections.
- All study subjects will receive plain CT brain and perfusion D4-7 post EVT to look for MBE, sICH and hyperperfusion. Additional brain imaging may also be arranged as per clinical needs.
- All study subjects will receive a standardized stroke protocol MRI D14-21 after EVT for quantification of infarct volume.
- NIHSS before and immediately after, D3, D14-21, D90±7 post-EVT will be assessed.
- mRS before, D14-21, D90±7 post-EVT will be assessed.
- Blood test before and immediately, 3 days and 14 days after EVT (D0pre, D0post, D3, D14-21) will be collected for neurovascular inflammatory markers and transcriptomic analysis.
- Capillary blood glucose, blood pressure and pulse will be measured four times daily in accordance to the standardized post-EVT protocol during the first 5 days hospitalization. The frequency of monitoring may increase according to the clinical needs.
- The following data will be collected:
- Demographic data: date of birth, date of death (if applicable), smoking and drinking status
- Medical comorbidities: Hypertension, diabetes mellitus, hyperlipidemia, congestive heart failure, atrial fibrillation, ischemic heart disease, history of ischemic or hemorrhagic stroke, etc.
- Co-medications: Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, heparin, warfarin), antiplatelet agents (aspirin, clopidogrel, ticagrelor, cilostazol), lipid-lowering agents (simvastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin, ezetimibe, gemfibrozil, fenofibrate, erenumab), antihypertensive (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, calcium channel blockers, diuretics, aldosterone antagonists, nitrates, etc.), non-steroidal antiinflammatory agents or cyclo-oxygenase2 inhibitors (indomethacin, ibuprofen, diclofenac, celecoxib, etorixocib), glucose lowering drugs (metformin, gliclazide, glimepiride, empagliflozin, dapagliflozin, insulin).
- Routine blood tests including hemoglobin, white cell count, lymphocyte count, neutrophil count, creatinine, alanine transferase, alkaline phosphatase, bilirubin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglyceride, fasting glucose, glycated hemoglobin A1c, etc. These blood tests are part of routine clinical care pre- and post-stroke.
- Imaging data: ASPECT score, site of occlusion, collateral score, volume of infarct core, penumbra, mismatch volume and mismatch ratio.
- Stroke time metrics: LKW-to-hospital, -imaging, -needle, -puncture, -reperfusion time.
- EVT outcomes: modified thrombolysis in cerebral infarction (TICI) score.
- Occurrence of MBE, asymptomatic or symptomatic ICH, hemorrhagic transformation, subarachnoid hemorrhage (see Endpoint measurement for details).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 140 patients will be randomized to "treatment arm" with semaglutide and standard medical therapy, and "control arm" with standard medical therapy alone in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Group | Active comparator | Drug: SemaglutidePrescribe study drug: Patients randomized into the semaglutide group will receive 0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. semaglutide group will receive a total of 2 injections. |
| Standard of care | No intervention | –Standard medical therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- LVO stroke at terminal ICA or proximal M1 eligible for emergency endovascular treatment as per current treatment guideline.
- LKW-to-puncture time ≤ 12 hours.
- Age 18 years or greater.
- National Institute of Health Stroke Scale (NIHSS) ≥10
- LVO stroke due to thromboembolism or intracranial stenosis (acute or acute on chronic occlusion).
Key exclusion criteria (15 listed)
- ASPECT score ≤ 5.
- Intracranial hemorrhage on pre-EVT imaging.
- LVO etiologies other than thromboembolism or intracranial stenosis (acute or acute on chronic total occlusion), e.g. arterial dissection, infective endocarditis on initial diagnostic imaging.Estimated or known body mass index < 18 kg/m2
- Estimated or known body mass index < 18 kg/m2.
- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
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 |
|---|---|---|
| Semaglutide0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. patient will receive a total of 2 injections. | Drug | Semaglutide Group |
Primary outcome
Change of Modified Rankin Score
Time frame: Day 90
Change of Modified Rankin Score to measure degree of disability/dependence. Scores 0-2 is considered good outcome, while scores 3-6 is considered poor outcome.
Composite Safety Outcome
Time frame: Day 90
Composite of Death, Intracranial Hemorrhage (ICH) and Malignant Brain Edema (MBE)
9 secondary outcomes
Malignant brain edema (MBE)
Time frame: From Day 0 post treatment, up to 90 Days.
Symptomatic intracranial hemorrhage (sICH)
Time frame: From Day 0 post treatment, up to 90 Days.
Blood-brain-barrier (BBB) permeability
Time frame: From Day 0 post treatment, up to 90 Days.
Hemorrhagic transformation and parenchymal hemorrhage
Time frame: From Day 0 post treatment, up to 90 Days.
Modified Rankin Score (mRS) 0-3
Time frame: From Day 0 post treatment, up to 90 Days.
Modified Rankin Score (mRS) 0-1
Time frame: From Day 0 post treatment, up to 90 Days.
Infarct size
Time frame: Day 14-21
Death
Time frame: Day 90
Ordinal shift in Modified Rankin Score (mRS)
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 41392086Wang H, Ko H, Leung TW, Huang J, Sai J, Liang Y, Li H, Zhang J, Cao Q, Zang W, Li Y, Ma SH, Lui WT, Choi J, Chan C, Wong J, Kwok AJ, Ma K, Fan F, Chan A, Ip V, Leung H, Soo Y, Wong KT, Lai B, Chu CM, Leung HS, Hui A, Cheung T, Abrigo J, Li SH, Chan L, Yeung J, Pan S, Yip T, Lui LT, Hung T, Tsang SF, Leng X, Lam B, Mok VCT, Chan RHM, Nguyen TN, Hu W, Che F, Ip BY. Glucagon-like peptide-1 receptor agonist in large vessel occlusion treated by reperfusion therapy-a phase 2 randomized trial. Nat Commun. 2025 Dec 14;16(1):11274. doi: 10.1038/s41467-025-66167-z.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
Bonaventure Yiu Ming IP, MB ChB principal investigator
Chinese University of Hong Kong
Fengyuan CHE, MD,PhD principal investigator
Linyi People's Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Stroke and Stroke, Acute, run by Chinese University of Hong Kong at 2 sites in 2 countries.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Modified Rankin Score (time frame: Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920889, which also lists 1 linked publication.
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 7 Mar 2025.