Effects of GLP-1 analogue in multiple sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Comenius University Bratislava

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2024-11-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministry of Health of Slovak Republic · Slovak Research and Development Agency (APVV)

External identifiers

EU CT number

2024-519235-42-00

EudraCT number

2019-003001-94

ClinicalTrials.gov

NCT01444833

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Primary objectives
To determine the effect of a GLP-1 receptor agonist on chronic axonal damage and neurodegeneration in MS patients

Secondary objectives 1

1. Secondary objectives. To determine the effect of a GLP-1 receptor agonist on insulin sensitivity in MS patients. To determine the effect of a GLP-1 receptor agonist on cognitive function in patients with MS.

Conditions and MedDRA coding

Patients with confirmed multiple sclerosis (MS), with worse prognosis given the higher disease activity, in productive age between 18 and 60 years, with EDSS<5, who at the time of investigation are on baseline therapy of the disease for at least 3 months

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint: Annualized change in brain volume and gray matter volume. Serum neurofilament L level.

Secondary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Comenius University Bratislava

Sponsor organisation

Comenius University Bratislava

Address

Mickiewiczova 13

City

Bratislava

Postcode

811 07

Country

Slovakia

Scientific contact point

Organisation

Comenius University Bratislava

Contact name

prof. MUDr. Peter Turčáni, PhD.

Public contact point

Organisation

Comenius University Bratislava

Contact name

prof. MUDr. Peter Turčáni, PhD.

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications