Actively Recruiting
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
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
B
Bispebjerg Hospital
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive subcutaneous Semaglutide 0.5 mg weekly for 4 weeks starting at inclusion, along with standard stroke care as per Danish clinical guidelines.
Weekly visits for 4 weeks
Duration - Up to 12 months
Participants are monitored for safety, functional outcomes, and recurrence of events up to 12 months after treatment.
Visits at 24 hours, 90 days, and 12 months
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8000
Actively Recruiting
Research Team
T
Thomas Mellemkjaer, MD
C
Claus Z Simonsen, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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