What is Semaglutide studying for acute ischemic stroke?

Semaglutide is being studied to see if it can help protect brain cells and improve recovery after an acute ischemic stroke in non-diabetic patients. The trial compares Semaglutide plus standard stroke care with standard care alone to evaluate its safety and effects. Aarhus University Hospital is leading this research to explore new treatment options for stroke patients.

Who may be eligible for this acute ischemic stroke clinical trial?

Adults 18 years or older who have had an acute ischemic stroke with disabling neurological symptoms may be eligible. The study includes both men and women without diabetes, with a body mass index of 22 or higher, and who are not pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this acute ischemic stroke clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses like travel may not be covered and can vary. Participants should expect to cover such costs themselves if applicable.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05630586

The Safety and Efficacy of Acute Subcutaneous Semaglutide in Non-diabetic Patients With Acute Ischemic Stroke A Multicentre, Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint Trial

Led by Aarhus University Hospital · Updated on 2023-04-25

380

Participants Needed

Research Sites

117 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Semaglutide in non-diabetic patients who have experienced an acute ischemic stroke. This type of stroke occurs when a blood clot blocks an artery in the brain, leading to brain cell damage or death. Even with current treatments that restore blood flow, many patients still face lasting disability. Semaglutide, a drug used for diabetes and obesity, has shown promise in animal studies for protecting brain cells during stroke, and this trial aims to see if it can improve outcomes in humans. Participants will be randomly assigned to one of two groups one receiving a weekly subcutaneous injection of 0.5 mg Semaglutide for four weeks plus standard stroke care, and the other receiving only the standard care according to national guidelines. The first dose of Semaglutide is given at the time of enrollment. The study compares these groups to assess whether Semaglutide reduces the impact of stroke beyond the usual treatments. Throughout the study, participants will be monitored for their functional recovery using the Modified Ranking Scale roughly three months after treatment. Researchers will also evaluate safety by tracking adverse events and mortality over the course of one year. Additional assessments include neurological improvement within 24 hours, changes in body weight and blood sugar levels, and recurrence of stroke or related events. The total observation period extends up to one year to gather comprehensive data on patient outcomes and safety.

CONDITIONS

Brief Title

Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male and female patients aged 18 years or older at the time of consent
Acute ischemic stroke with disabling neurological deficits affecting language, motor function, cognition, gaze, vision, neglect, or ataxia
Time from stroke onset or last seen well to randomization less than 4.5 hours
None to moderate disability in daily living before stroke (pre-stroke modified Rankin Scale 0-3)

You will not qualify if you...

Known diabetes or blood glucose above 11.1 mmol/L at admission
Body mass index less than 22
History of pancreatitis or medullary thyroid carcinoma
Known predisposition to Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Life expectancy less than 12 months or severe neurodegenerative disease
Pregnancy, planned pregnancy within 12 months, or breastfeeding
Severe kidney impairment with estimated glomerular filtration rate below 30 mL/min/1.73 m2

Research Team

Thomas Mellemkjaer, MD

Claus Z Simonsen, Professor

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