Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

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.

Conditions

• Acute Ischemic Stroke

Interventions

DRUG

Semaglutide

Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.

OTHER

Standard care

Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.

Sponsors & Collaborators

• Bispebjerg Hospital

  collaborator OTHER

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Aarhus University Hospital

  lead OTHER

Principal Investigators

• Claus Z Simonsen, Professor · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-12

Primary Completion

2025-09-30

Completion

2027-12-31

Countries

• Denmark

Study Locations