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Study on the Safety and Effectiveness of Semaglutide for Non-Diabetic Patients with Acute Ischemic Stroke

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called semaglutide in patients who have experienced an ischemic stroke. An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow and potentially leading to brain damage. The purpose of the study is to determine the safety and effectiveness of administering semaglutide shortly after a stroke. Semaglutide is typically used to treat diabetes, but this study is exploring its potential benefits for stroke patients who do not have diabetes.

Participants in the study will receive semaglutide through a subcutaneous injection, which means it is injected under the skin. The study will compare the outcomes of patients receiving semaglutide with those who do not, to see if semaglutide can improve recovery after a stroke. The study will monitor various health indicators over time, including the patient's ability to perform daily activities, any changes in body weight, and overall quality of life. The study will also track any serious side effects that may occur.

The trial will last for several months, with follow-up assessments at different intervals to evaluate the long-term effects of semaglutide on stroke recovery. The goal is to see if semaglutide can help improve the functional outcomes for patients who have suffered an ischemic stroke, potentially offering a new treatment option for this condition. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be randomly assigned to receive either the study medication or a standard treatment. This process is called randomization and ensures that the study results are unbiased.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This may include physical examinations, blood tests, and imaging studies to confirm the diagnosis of ischemic stroke.
Step 3
Medication administration
If you are assigned to the study medication group, you will receive semaglutide as a subcutaneous injection. This means the medication is injected under the skin. The dosage will be determined by the study team and administered in the acute phase after the stroke.
Step 4
Monitoring and follow-up
Throughout the trial, your health will be closely monitored. This includes regular check-ups to assess your recovery and any side effects from the medication. You may be required to visit the clinic for follow-up assessments at specified intervals.
Step 5
Evaluation of outcomes
The primary goal is to determine the safety and effectiveness of semaglutide in improving functional outcomes after a stroke. Your progress will be evaluated using various scales and tests to measure your recovery and any changes in your health status.
Step 6
Completion of the trial
At the end of the trial, a final assessment will be conducted. This will include a comprehensive evaluation of your health and any changes observed during the study period. The results will contribute to understanding the potential benefits of semaglutide for stroke patients.

Who can join the trial?

4 criteria

Men and women who are 18 years or older at the time they sign the consent form.
Have had an acute ischemic stroke with significant problems in areas like language, movement, thinking, eye movement, vision, attention, or coordination.
The stroke symptoms started less than 4.5 hours ago, or if the exact time is unknown, an MRI scan shows specific signs and it's been less than 4.5 hours since symptoms were noticed.
Had little to moderate difficulty in daily activities before the stroke, as measured by a scale called the modified Rankin Scale, with a score between 0 and 3.

Who cannot join the trial?

4 criteria

Patients who have had a recent **ischemic stroke** cannot participate. An ischemic stroke is when a blood clot blocks or narrows an artery leading to the brain.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which may include those with certain health conditions or social situations, cannot participate.
Patients who do not meet the specific health criteria set by the study cannot participate. These criteria are designed to ensure the safety and effectiveness of the treatment being tested.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Bispebjerg Hospital
Verified
Copenhagen, Denmark

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Investigated drugs

Semaglutide is a medication that is being tested in this clinical trial to see if it can help people who have had a type of stroke called an ischemic stroke. This medication is given as an injection under the skin. The main goal of using semaglutide in this study is to find out if it is safe and effective when given to patients soon after they have had a stroke. Researchers want to see if semaglutide can help improve recovery and outcomes for these patients. The trial is designed to carefully monitor how patients respond to the medication and to check for any side effects.

What is already known about the treatment

Semaglutide – Semaglutide is administered through an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials for its safety and effectiveness in treating patients who have had an acute ischemic stroke, even if they do not have diabetes. The main therapeutic use being explored is to help improve outcomes after a stroke. At the molecular level, semaglutide works by mimicking a natural hormone in the body that helps regulate blood sugar and has protective effects on the brain. It is classified as a GLP-1 receptor agonist, which is a type of medication that interacts with specific receptors in the body to produce its effects.

Investigated diseases

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes. The progression of an ischemic stroke can lead to sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. As the stroke progresses, it may also cause vision problems, dizziness, loss of balance, or severe headache. The extent of the damage depends on the location and duration of the blockage. Recovery and improvement in symptoms can vary widely among individuals.