Acute Ischemic StrokePhase 3GALLOP2NCT06788626
Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment
A Phase 3 study testing Semaglutide 0.5 mg and Standard medical treatment in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Wei Hu at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion, Neuroprotective Drugs
- What is being tested?
- Semaglutide 0.5 mg and Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Feb 2028
- Phase
- Phase 3
- 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
- LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours
- Age ≥ 18 years old
- National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging
- Acute LVO stroke due to thromboembolism or intracranial stenosis
- Patients who received computer tomographic or magnetic resonance angiography
- ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours
- Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours
- Informed consent obtained from patient or acceptable patient surrogate.
Who cannot join
- Use of intravenous thrombolytic therapy (alteplase or tenecteplase)
- Pre-stroke mRS > 2 for patients <80 years and > 1 for patients ≥ 80 years old
- Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
- Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
- Unstable hemodynamics on presentation that require resuscitation
- Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg that cannot be controlled by antihypertensive drugs
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- Severe comorbid illness, e.g. terminal malignancy with life expectancy <1 year
- Pregnant or lactating female
- Participation in another clinical trial
- Contraindications to GLP1-RA, including history of allergy to GLP-1RA, family or personal history of multiple endocrine neoplasia, medullary thyroid or pancreatic carcinoma, or proliferative diabetic retinopathy
- Blood glucose <2.7 or > 22.2 mmol/L; platelet count <50x10^9 /L; INR >1.7
- Patients with known estimated glomerular filtration rate of <30ml/min/1.73m2 or creatinine >3mg/dL (265.2µmol/L); chronic liver disease with Child's Pugh score C or above; or recurrent unexplained hypoglycemia.
- Suspected or confirmed vasculitis of the central nervous system
- Unable to complete 90-day follow-up assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Wei Hu, MD,PhD, +8615155510611, andinghu@ustc.edu.cn
About this study
The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive the endovascular treatment (EVT)? Researchers will compare semaglutide injection to non-injection to see if semaglutide works to improve the functional outcome in participants with EVT.
Participants will:
- Receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT , or EVT alone.
- Have additional blood test before and after EVT.
- Receive neurological assessment before EVT, Day 1, Day 3, Day 5-7 after EVT or on hospital discharge (whichever earlier), Day 90±14 after EVT. Audio or video of the assessment may be recorded if possible.
- Receive brain CT + CT angiogram + CT perfusion and MRI after EVT, where the CT scan may be repetitive.
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion, Neuroprotective Drugs, Endovascular Treatment
- Being tested
- Semaglutide 0.5 mg, Standard medical treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 0.5 mgDrug
0.5mg semaglutide injection before and 1 week after endovascular treatment.
Standard medical treatmentOther
Standard medical management
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Experimental | Participants will receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT. Additionally, they will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines. Receives: Drug: Semaglutide 0.5 mg; Other: Standard medical treatment |
| Standard medical management | Placebo comparator | Standard medical management. Participants will receive EVT, antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines. Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ordinal shift of modified Rankin Scale
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Measured: 90±14 days after procedure
Secondary outcomes (6)
Proportion of patients with functional independence outcome (mRS 0-1) at day 90
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90±14 days after procedure
Proportion of patients with functional independence outcome (mRS 0-2) at day 90
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90±14 days after procedure
Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90±14 days after procedure
Neurological Function of Participants Assessed by National Institute of Health Stroke Scale
Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively.
Measured: Day 1, Day 3, Day 5-7 after EVT (or at discharge, when the patient is discharged on day 5-7)
Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level
Participants rated themselves on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was distributed from "no problems at all" to "very serious problems".
Measured: 90±14 days after endovascular treatment
Activities of Daily Living of Participants Assessed by Bathel Index
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
Measured: 90±14 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor-investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788626
- Sponsor's protocol ID
- GALLOP2
- Acronym
- GALLOP2
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 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 After Endovascular Treatment
- ClinicalTrials.gov ID
- NCT06788626
- Acronym / sponsor ID
- GALLOP2 / GALLOP2
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion, Neuroprotective Drugs, Endovascular Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Wei HuUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Jan 2025 (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.
The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive the endovascular treatment (EVT)? Researchers will compare semaglutide injection to non-injection to see if semaglutide works to improve the functional outcome in participants with EVT.
Participants will:
- Receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT , or EVT alone.
- Have additional blood test before and after EVT.
- Receive neurological assessment before EVT, Day 1, Day 3, Day 5-7 after EVT or on hospital discharge (whichever earlier), Day 90±14 after EVT. Audio or video of the assessment may be recorded if possible.
- Receive brain CT + CT angiogram + CT perfusion and MRI after EVT, where the CT scan may be repetitive.
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: Semaglutide 0.5 mg, Other: Standard medical treatmentParticipants will receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT. Additionally, they will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines. |
| Standard medical management | Placebo comparator | Other: Standard medical treatmentStandard medical management. Participants will receive EVT, antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours
- Age ≥ 18 years old
- National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging
- Acute LVO stroke due to thromboembolism or intracranial stenosis
- Patients who received computer tomographic or magnetic resonance angiography
Key exclusion criteria (14 listed)
- Use of intravenous thrombolytic therapy (alteplase or tenecteplase)
- Pre-stroke mRS > 2 for patients <80 years and > 1 for patients ≥ 80 years old
- Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
- Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
- Unstable hemodynamics on presentation that require resuscitation
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 |
|---|---|---|
| Semaglutide 0.5 mg0.5mg semaglutide injection before and 1 week after endovascular treatment. | Drug | semaglutide |
| Standard medical treatmentStandard medical management | Other | Standard medical management, semaglutide |
Primary outcome
The ordinal shift of modified Rankin Scale
Time frame: 90±14 days after procedure
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
6 secondary outcomes
Proportion of patients with functional independence outcome (mRS 0-1) at day 90
Time frame: 90±14 days after procedure
Proportion of patients with functional independence outcome (mRS 0-2) at day 90
Time frame: 90±14 days after procedure
Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90
Time frame: 90±14 days after procedure
Neurological Function of Participants Assessed by National Institute of Health Stroke Scale
Time frame: Day 1, Day 3, Day 5-7 after EVT (or at discharge, when the patient is discharged on day 5-7)
Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level
Time frame: 90±14 days after endovascular treatment
Activities of Daily Living of Participants Assessed by Bathel Index
Time frame: 90±14 days after procedure
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 23 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide 0.5 mg and Standard medical treatment in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Wei Hu at 1 site in China.
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 14 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wei Hu, MD, PhD (+86 055162284313, andinghu@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ordinal shift of modified Rankin Scale (time frame: 90±14 days after procedure). 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 23 Jan 2025.