Acute Subcutaneous Semaglutide in Acute Ischemic Stroke (ASSET Trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aarhus University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nervous System Diseases [C10]

Trial duration

12 Apr 2023 → ongoing

Decision date (initial)

2022-10-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To determine safety and efficacy of administering subcutaneous semaglutide in the acute phase after an ischemic stroke

Conditions and MedDRA coding

Ischemic Stroke

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent
2. 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)
3. Onset/last seen well to randomization < 4.5 hours, or DWI-FLAIR mismatch on MRI in patients with unknown time of onset and < 4,5 hours since symptoms were acknowledged
4. None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3)

Exclusion criteria 7

1. Diabetes (known) or plasma/point of care test-glucose >11.1 mmol/L at admission
2. BMI< 22
3. History of pancreatitis, medullary thyroid carcinoma
4. Predisposition or known Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
5. Short remaining life expectancy (< 12months) and/or severe neurodegenerative disease
6. Pregnancy or planned pregnancy within 12 months or breastfeeding
7. History of renal impairment (estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m2)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. A shift toward better functional outcomes in the distribution of the modified Ranking Scale (mRS) (ordinal logistic regression)

Secondary endpoints 25

1. Proportion of patients with a Serious Adverse Events and/or Serious Unexpected Serious Adverse Events within 90 days of randomization
2. 90-day mortality
3. One-year mortality
4. Frequency of predefined serious adverse events
5. Excellent functional outcome (modified Rankin Scale 0-1) at 90 days
6. Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 3 months in AIS patients
7. Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 12 months in AIS patients
8. Stroke recurrence at 12 months in patients with a stroke due to small vessel disease
9. Early neurological improvement (NIHSS_24hour – NIHSS_baseline)
10. Change in body weight (kg) (week 12-baseline)
11. Change in fasting plasma glucose (week 12-baseline)
12. Change in body mass index (BMI) (week 12-baseline)
13. Change in waist circumference (week 12-baseline)
14. Difference in HbA1c (week 12-baseline)
15. Diabetes diagnosis and/or antidiabetic medication (week 52)
16. Systolic and diastolic blood pressure (week 12 BP - discharge BP)
17. Change in Quality of life (EQ5D, week 12- baseline)
18. Change in Major Depression Inventory (MDI, week 12- baseline)
19. Difference in activities of daily living - Multi Data Set –Home Care (MDS-HC, week 12)
20. 24-hour infarct growth on DWI-MRI
21. Acute and long-term platelet inhibition in Semaglutide treated patients
22. The effect of semaglutide in non-diabetic stroke patients on insulin, c-peptide, glucagon and 3-hydroxybuturate levels
23. The effect of semaglutide in non-diabetic stroke patients on leptin, cholecystokinin (CCK) and gastric inhibitory polypeptide (GIP)
24. Proportion of patients diagnosed with dementia (all-cause) at 12 months
25. Change in TICS score (12 months - 90 days)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus University Hospital

Sponsor organisation

Aarhus University Hospital

Address

J120, Palle Juul-Jensens Boulevard 165 Palle Juul-Jensens Boulevard 165

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Aarhus University Hospital

Contact name

Department of Neurology, Neurovascular team information desk

Public contact point

Organisation

Aarhus University Hospital

Contact name

Hospital information desk

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications