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Study on the Effects of Semaglutide and Dulaglutide in Adults with Multiple Sclerosis Aged 18-60 with High Disease Activity

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 treatment on patients with multiple sclerosis (MS), a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The study will use a type of medication known as a GLP-1 receptor agonist, which includes drugs like Rybelsus (containing semaglutide) and Trulicity (containing dulaglutide). These medications are typically used to manage blood sugar levels in people with diabetes but are being explored here for their potential benefits in MS.

The purpose of this study is to determine how these medications might affect long-term nerve damage and brain health in people with MS. Participants will receive either the medication or a placebo and will be monitored over a period of time to observe any changes in their condition. The study will involve regular check-ups and assessments to track the progress and effects of the treatment.

Throughout the study, participants will be asked to undergo various tests to measure different aspects of their health, including brain scans and blood tests. These tests will help researchers understand how the treatment impacts brain volume and nerve health. The study aims to provide valuable insights into whether these medications can offer new ways to manage MS and improve the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of relapsing-remitting multiple sclerosis and ensuring stable treatment for at least three months.
The assessment also involves confirming age between 18 and 60 years and an EDSS score of less than 5.
Step 2
Medication administration
The study involves the administration of GLP-1 receptor agonists to evaluate their effects on multiple sclerosis.
The medications include Rybelsus tablets in doses of 3 mg, 7 mg, and 14 mg, taken orally.
Additionally, Trulicity is administered as a 0.75 mg solution for injection using a pre-filled pen.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the primary endpoint, which includes changes in brain volume and gray matter volume, as well as serum neurofilament L levels.
Secondary endpoints involve evaluating insulin sensitivity and cognitive function through specific tests such as the Symbol Digit Modalities Test and Stroop Test.
Step 4
Completion of trial
The trial is expected to conclude by December 31, 2026.
Upon completion, data collected will be analyzed to determine the effects of the medication on chronic axonal damage and neurodegeneration in multiple sclerosis patients.

Who can join the trial?

8 criteria

Must freely agree to participate in this trial and personally sign the informed consent before any study procedures begin.
Can be either male or female, aged between 18 and 60 years at the time of the first visit to this study.
Must be able to understand the study requirements and follow the procedures.
Must have a confirmed diagnosis of **relapsing-remitting multiple sclerosis**. This is a type of multiple sclerosis where symptoms flare up and then improve.
Must have a worse prognosis due to higher disease activity, meaning the disease is more active and may progress faster.
Must have had the disease for at least 1 year.
Must have an **EDSS** score of less than 5. EDSS stands for **Expanded Disability Status Scale**, which measures the level of disability in people with multiple sclerosis.
Must be on stable treatment for the disease for at least three months.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with multiple sclerosis (MS). MS is a condition that affects the brain and spinal cord.
Patients who are younger than 18 years or older than 60 years.
Patients with an Expanded Disability Status Scale (EDSS) score of 5 or higher. The EDSS is a method of measuring disability in people with MS.
Patients who have not been on their current MS treatment for at least 3 months.

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Verified sites

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Verified
University Hospital Bratislava
Bratislava, Slovakia

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Investigated drugs

GLP-1 Receptor Agonist is a type of medication that is being studied for its potential effects on patients with multiple sclerosis (MS). This medication works by activating the GLP-1 receptors in the body, which may help reduce chronic nerve damage and slow down the process of neurodegeneration in people with MS. The goal of using this medication in the trial is to see if it can provide benefits in managing the symptoms or progression of multiple sclerosis.

What is already known about the treatment

GLP-1 Analogue – This medication is administered via injection and is currently being studied for its effects on multiple sclerosis (MS). It is in the clinical trial phase, focusing on patients with higher disease activity. The main therapeutic indication is to assess its impact on chronic axonal damage and neurodegeneration in MS. At the molecular level, it works by activating GLP-1 receptors, which may help protect nerve cells. It is classified as a GLP-1 receptor agonist, commonly used in diabetes treatment, but now being explored for neurological benefits.

Investigated diseases

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapses. The severity and specific symptoms can differ greatly from person to person.