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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Thomas Mellemkjaer, MD
thomas.mellemkjaer@rm.dk
004551430175
Backup
Claus Z Simonsen, Professor
clausimo@rm.dk
004523669875
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 380
Treatments
Active_comparator: Semaglutide 0.5 mg
Inj. Semaglutide 0.5 mg s.c., 0.5 mg per week for 4 weeks~\+ standard care
Other: Control
Standard care
Related Therapeutic Areas
Sponsors
Collaborators: Bispebjerg Hospital, Herning Hospital, Odense University Hospital, Aalborg University Hospital, Glostrup University Hospital, Copenhagen, Rigshospitalet, Denmark
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov