Ocrelizumab and GLP‑1 agonists in people with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort will follow adults with MS who are already taking ocrelizumab and a GLP‑1 agonist for approximately 72 weeks, with data collection every four weeks using remote surveys and periodic Zoom checks. Aim 1 uses patient‑reported outcomes including the PDDS and ambulation score as primary endpoints, while Aim 2 compares clinical disability measures (EDSS, 25‑foot walk, 9‑hole peg test, SDMT) before GLP‑1 start and at week 72 to identify progression independent of relapse activity (PIRA). Participants report medication use, weight, exercise, tolerability, and other PROMS; coordinators follow up by phone if surveys are missed. The study enrolls participants with available MRI confirmation of MS and excludes those with recent relapse, recent systemic steroids, prior lymphoablative treatments, or very low BMI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of MS (2019 revised McDonald criteria) of any type (PPMS, RRMS, SPMS) by a neurologist,
* Adult age 18-70 years,
* BMI \>=24.0 kg/m2,
* Taken at least one dose of Ocrelizumab prior to study entry,
* EDSS \<7.0,
* Able to provide individual informed consent,
* MRI available to confirm the diagnosis of MS.

Exclusion Criteria:

* Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,
* Current clinical trial participant,
* Unable to speak a language for which translation can be found in the hospital system,
* Unclear documentation of MS diagnosis or prior or current MS treatment,
* Relapse within the past 3 months,
* Recent major surgical procedure in the past 6 months,
* Exposure to steroids (systemic) within the past 3 months,
* Not on Ocrelizumab in the past \>9 months,
* Moribund status,
* Underweight or experiencing protein malnutrition,
* Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, dementia, etc.),
* Unable to complete the study activities for any reason as deemed by the study investigator.

Additional Inclusion Criteria Aim 1:

* Exposed to GLP-1 agonist treatment in the last 3 years or less, or starting on a GLP-1 agonist in the coming \<3 months,
* Willing to report monthly patient-reported outcomes remotely or in-person.

Additional Inclusion Criteria Aim 2:

* Able to present for baseline and follow up in person,
* Unexposed to a GLP-1 agonist in the past year,
* Starting on a GLP-1 agonist in the next \<6 months,
* Plan to be exposed to GLP-1 agonist for a minimum of 72 weeks following enrollment.

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Farrah J Mateen — Northwestern University
• Study coordinator: Dylan Rice, BA
• Email: dylan.rice@northwestern.edu
• Phone: 240-362-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.