Using Semaglutide to reduce damage from 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
This study is testing if Semaglutide can help reduce brain damage in people who have had an acute ischemic stroke and had no to moderate disability before the stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05630586 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of Semaglutide in non-diabetic patients who have experienced an acute ischemic stroke. The ASSET trial is a national, multicenter effort aimed at determining whether Semaglutide can help minimize brain damage caused by the stroke. Participants will receive Semaglutide alongside standard care within 4.5 hours of stroke onset. The study focuses on patients with disabling neurological deficits but who had no to moderate disability prior to the stroke.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke with disabling neurological deficits and no prior diabetes.
Not a fit: Patients with known diabetes, severe neurodegenerative diseases, or significant renal impairment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce long-term disability in stroke patients.
How similar studies have performed: While the use of Semaglutide in this context is novel, other studies have explored similar neuroprotective strategies in stroke management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Claus Z Simonsen, Professor — Aarhus University Hospital
- Study coordinator: Thomas Mellemkjaer, MD
- Email: thomas.mellemkjaer@rm.dk
- Phone: 004551430175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.