DelfaGLP-1 Atlas

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GALLOP

CompletedPhase 2

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies - a Pilot Study

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

2

Recruiting sites

—

Enrollment

140

actual

Study population

Stroke

Key I/E criterion

—

Primary endpoints

•Modified Rankin Score•Composite Safety Outcome (All-cause death, Stroke (any))

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 IDNCT05920889
Org study IDCREC 2023.026-T

Timeline

Milestones

Study first posted2023-06-27actual
Study start2023-08-01actual
Primary completion2024-10-25actual
Study completion2024-10-25actual
Last update posted2025-03-07actual

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Stroke

Eligibility

Who can enroll

Minimum age18 Years
Maximum age100 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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.
•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.

Endpoints (11)

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
6
Other clinical outcomes
4
Safety / tolerability / PK
1

Cardiovascular outcomes

6 endpoints
Secondary/protocol endpoint

Symptomatic intracranial hemorrhage (sICH)

Time frame:From Day 0 post treatment, up to 90 Days.

event count, event

Secondary/protocol endpoint/low confidence

Hemorrhagic transformation and parenchymal hemorrhage

Time frame:From Day 0 post treatment, up to 90 Days.

event count, event

Secondary/protocol endpoint

Modified Rankin Score (mRS) 0-3

Time frame:From Day 0 post treatment, up to 90 Days.

threshold achievement, improvement

Secondary/protocol endpoint

Modified Rankin Score (mRS) 0-1

Time frame:From Day 0 post treatment, up to 90 Days.

threshold achievement, improvement

Secondary/protocol endpoint

Infarct size

Time frame:Day 14-21

descriptive

Secondary/protocol endpoint

Death

Time frame:Day 90

All-cause death

time to event, event

SNOMED 419620001

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint/low confidence

Composite Safety Outcome

Time frame:Day 90

composite event, event

componentsAll-cause death, Stroke (any)

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Change of Modified Rankin Score

Time frame:Day 90

change from baseline, improvement

Secondary/protocol endpoint

Malignant brain edema (MBE)

Time frame:From Day 0 post treatment, up to 90 Days.

categorical status, event

Secondary/protocol endpoint/low confidence

Blood-brain-barrier (BBB) permeability

Time frame:From Day 0 post treatment, up to 90 Days.

change from baseline, descriptive

Secondary/protocol endpoint

Ordinal shift in Modified Rankin Score (mRS)

Time frame:Day 90

categorical status, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.