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GALLOP2

Not yet recruitingPhase 3

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment

Lead sponsor

Wei Hu

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

390

estimated

Study population

Stroke

Key I/E criterion

—

Primary endpoint

•Ordinal shift of modified Rankin Scale

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06788626

Org study IDGALLOP2

Timeline

Milestones

Study first posted2025-01-23actual

Last update posted2025-01-23actual

Study start2025-02estimated (month precision)

Primary completion2028-02estimated (month precision)

Study completion2028-02estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Stroke

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours

2. Age ≥ 18 years old

3. National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging

4. Acute LVO stroke due to thromboembolism or intracranial stenosis

5. Patients who received computer tomographic or magnetic resonance angiography

6. ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours

7. Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours

8. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion criteria

1. Use of intravenous thrombolytic therapy (alteplase or tenecteplase)

2. Pre-stroke mRS > 2 for patients <80 years and > 1 for patients ≥ 80 years old

3. Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)

4. Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation

5. Unstable hemodynamics on presentation that require resuscitation

6. Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg that cannot be controlled by antihypertensive drugs

7. Severe comorbid illness, e.g. terminal malignancy with life expectancy <1 year

8. Pregnant or lactating female

9. Participation in another clinical trial

10. 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

11. Blood glucose <2.7 or > 22.2 mmol/L; platelet count <50x10^9 /L; INR >1.7

12. 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.

13. Suspected or confirmed vasculitis of the central nervous system

14. Unable to complete 90-day follow-up assessment

Endpoints (8)

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

Other clinical outcomes

Cardiovascular outcomes

Patient-reported / QoL

Cardiovascular outcomes

2 endpoints

Primary/protocol endpoint

The ordinal shift of modified Rankin Scale

Time frame:90±14 days after procedure

descriptive, improvement

Other/protocol endpoint

Intracranial Hemorrhage (ICH)

Time frame:48-72 hours after EVT

categorical status, event

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level

Time frame:90±14 days after endovascular treatment

EQ-5D index

descriptive, improvement

Other clinical outcomes

5 endpoints

Secondary/protocol endpoint

Proportion of patients with functional independence outcome (mRS 0-1) at day 90

Time frame:90±14 days after procedure

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of patients with functional independence outcome (mRS 0-2) at day 90

Time frame:90±14 days after procedure

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90

Time frame:90±14 days after procedure

threshold achievement, improvement

Secondary/protocol endpoint

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)

descriptive

Secondary/protocol endpoint

Activities of Daily Living of Participants Assessed by Bathel Index

Time frame:90±14 days after procedure

descriptive, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.