Effects of GLP-1 analogue in multiple sclerosis
Effects of GLP-1 analogue in multiple sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Trulicity 0,75 mg injekčný roztok naplnený v injekčnom pere
- Semaglutide
Glucagon-like peptide 1 receptor agonist
- Dulaglutide
Glucagon-like peptide 1 receptor agonist
What it measured
Main measures
To determine the effect of GLP-1 receptor agonist on chronic axonal damage and neurodegeneration in patients with MS
Primary endpoint: Annualized change in brain volume and gray matter volume. Serum neurofilament L level.
Brain volume lossBlood or spinal fluid markers
Other measures (2)
To determine the effect of GLP-1 receptor agonist on insulin sensitivity in patients with MS
Secondary end points: Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2. Scores in Symbol Digit Modalities Test (SDMT) and Stroop Test.
Thinking and memory
Who could take part
Relapsing MS · 18 to 64
Show the full criteria
Inclusion criteria
- Main inclusion criteria • Must freely consent to participate in this trial and personally sign the informed consent prior to performing any procedure in this study. • Male or female aged 18 to 60 years (inclusive) at the time of the first visit to this study. • Able to understand the requirements and follow the procedures within this study. • Patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis, with a worse prognosis due to higher disease activity, with a disease duration of at least 1 year • EDSS<5, • Set on stable treatment of the underlying disease for at least three (3) months
Exclusion criteria
- Main • diabetes mellitus on diet, oral antidiabetic drugs or insulin • other serious chronic diseases • Acute pancreatitiswith a historyof • oncological diseases • long-term use of medications such as glucocorticoids, Antidepressants • Severe renal impairment and kidney disease in the last stage. • Severe hepatic impairment. • Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transit ischemic attack in 90 days before the dateof screening. • New Class IV congestive heart failure York Heart Association (NYHA). • Historyof major surgical procedures involving the stomach or smallintestine potentially affecting the absorption of medicinal products and/or nutrients, as assessed by the • Pregnancy • breastfeeding • Drug use or alcoholuse • the presence of metal components in the body • Known hypersensitivity to the investigational drug, excipients or hypersensitivity to a drug with a similar structure.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
Primary objectives To determine the effect of a GLP-1 receptor agonist on chronic axonal damage and neurodegeneration in MS patients
Papers
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History
Started
Dec 2019
Finished
Dec 2026