ASSET

RecruitingPhase 2

Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

The Safety and Efficacy of Acute Subcutaneous Administration of Semaglutide in Non-diabetic Patients With Acute Ischemic Stroke: A Multicentre, Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint Trial

Lead sponsor

Aarhus University Hospital

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

380

estimated

Study population

Stroke

Key I/E criterion

—

Primary endpoint

•Modified Ranking 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 IDNCT05630586

Org study IDASSET

Secondary IDEUCT number: 2022-501072-25-02European Medicines Agency (EMA)

Timeline

Milestones

Study first posted2022-11-29actual

Study start2023-04-12actual

Last update posted2023-04-25actual

Primary completion2025-09estimated (month precision)

Study completion2027-12estimated (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

•Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent

•Acute ischemic stroke with disabling neurological deficits (defined as an impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect, or ataxia)

•Onset/last seen well to randomization < 4.5 hours

•None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3)

Exclusion criteria

•Diabetes (known) or plasma/point of care test-glucose >11.1 mmol/L at admission

•BMI< 22

•History of pancreatitis, medullary thyroid carcinoma

•Predisposition or known Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

•Short remaining life expectancy (< 12months) and/or severe neurodegenerative disease

•Pregnancy or planned pregnancy within 12 months or breastfeeding

•Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m2

Endpoints (25)

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

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

Other clinical outcomes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Cardiovascular outcomes

6 endpoints

Secondary/protocol endpoint

90-day mortality

Time frame:90 days

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

One-year mortality

Time frame:1 year

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint/low confidence

MACCE and recurrent ischemic events, 90 days

Time frame:90 days

CV events (total recurrent)

event count, event

componentsMyocardial infarction (any), Stroke (any)

Secondary/protocol endpoint

MACCE and recurrent ischemic events, 12 months

Time frame:12 months

CV events (total recurrent)

event count, event

componentsMyocardial infarction (any), Stroke (any), Cardiovascular death

Secondary/protocol endpoint

Stroke recurrence at 12 months in patients with a stroke due to small vessel disease

Time frame:12 months

Stroke (any)

time to event, event

SNOMED 230690007

Other/protocol endpoint/low confidence

Sub-study: 24-hour infarct growth

Time frame:24 (+/-8) hours

change from baseline, improvement

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in body weight (kg)

Time frame:90 (+/- 14) days

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:90 (+/- 14) days

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:90 (+/- 14) days

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:90 (+/- 14) days

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Difference in HbA1c

Time frame:90 (+/- 14) days

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Diabetes diagnosis and/or antidiabetic medication

Time frame:12 months

Time to T2DM onset

time to event, event

componentsTime to T2DM onset

Other/protocol endpoint

Sub-study: The effect of semaglutide in non-diabetic stroke patients on insulin, c-peptide, glucagon and 3-hydroxybuturate levels

Time frame:90 (+/- 14) days

descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Blood pressure, 90 days

Time frame:90 (+/- 14) days

change from baseline, improvement

Other/protocol endpoint/low confidence

Sub-study: The effect of semaglutide in non-diabetic stroke patients on leptin, ghrelin, cholecystokinin (CCK) and gastric inhibitory polypeptide (GIP)

Time frame:90 (+/- 14) days

Leptin, change

change from baseline, improvement

componentsLeptin, change, ghrelin change, cholecystokinin change, gastric inhibitory polypeptide change

Patient-reported / QoL

4 endpoints

Other/protocol endpoint

Patient reported outcome: Quality of Life (QoL)

Time frame:90 (+/- 14) days

EQ-5D index

change from baseline, improvement

Other/protocol endpoint

Patient reported outcome: Major Depression Inventory (MDI)

Time frame:90 (+/- 14) days

change from baseline, improvement

Other/protocol endpoint

Patient reported outcome: SSQOL-DK

Time frame:90 (+/- 14) days

change from baseline, improvement

Other/protocol endpoint

Patient reported outcome: Activities of daily living

Time frame:90 (+/- 14) days

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Serious Adverse Events and/or Serious Unexpected Serious Adverse Events

Time frame:90 days

Serious AEs (any)

threshold achievement, event

componentsSerious AEs (any)

Secondary/protocol endpoint

Predefined SAEs

Time frame:1 year

Serious AEs (any)

event count, event

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Modified Ranking Scale

Time frame:90 (+/- 14) days

categorical status, improvement

Secondary/protocol endpoint

Excellent functional outcome at 90 days

Time frame:90 (+/- 14) days

threshold achievement, improvement

Secondary/protocol endpoint

Early neurological improvement

Time frame:24 (+/- 8) hours

change from baseline, improvement

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Sub-study: Acute and long-term platelet inhibition in Semaglutide treated patients

Time frame:90 (+/- 14) days

descriptive

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.