NCT05630586 Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke
| NCT ID | NCT05630586 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Aarhus University Hospital |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 380 participants in total. It began in 2023-04-12 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke. Stroke is a worldwide leading cause of long-term disability and death. In the most common type of stroke (ischemic stroke), a blood clot obstructs an artery in the brain, and thereby prevents oxygenated blood from reaching an area of the brain. Brain cells are particularly vulnerable to the lack of oxygen. In the areas most severely affected by a stroke, brain cells die after 5 minutes. As more time pass, the affected area expands, and more brain cells perish. Today, efficient treatments aiming at reestablishing the flow of blood by either breaking down the blood clot (thrombolysis) or removing the clot (thrombektomi) are used. However, a significant amount of patients undergoing succesful treamtent, still suffer permanent disability following an ischemic stroke. Semaglutide mimics a naturally occurring hormone (glucagon-like peptide-1) and is currently used to treat diabetes and obesity. However, semaglutide has also been shown to possess neuroprotective abilities in recent animal studies, where it reduced the damage caused by ischemic stroke in rats. This study sets out to investigate if it's possible to utilize Semaglutide, to increase the resilience of brain cells in patients with an acute ischemic stroke, with the aim of bettering their outcome. The participants consist of non-diabetic patients with acute ischemic stroke, who will be randomized to: * Treatment with subcutaneous Semaglutide, or * No additional treatment (control group) Both groups will be treated according to the standard national guidelies for acute ischemic stroke. The two groups will then be compared to see, if patients in the group treated with Semaglutide are less impacted by their stroke.
Eligibility 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
Contact & Investigator
Claus Z Simonsen, Professor
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT05630586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05630586 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05630586 currently recruiting?
Yes, NCT05630586 is actively recruiting participants. Contact the research team at thomas.mellemkjaer@rm.dk for enrollment information.
Where is the NCT05630586 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT05630586 clinical trial?
NCT05630586 is sponsored by Aarhus University Hospital. The principal investigator is Claus Z Simonsen, Professor at Aarhus University Hospital. The trial plans to enroll 380 participants.
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