Ocrelizumab and GLP‑1 agonists in people with multiple sclerosis
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
This project will see if taking GLP‑1 weight‑loss medicines while on ocrelizumab changes progression of disability in adults with multiple sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | Ocrelizumab, Cyclophosphamide |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07207148 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults age 18–70 with a neurologist‑confirmed diagnosis of MS, BMI ≥24 kg/m2, EDSS <7.0, MRI confirming MS, and who have received ocrelizumab within the past 6 months and are taking a GLP‑1 medication are ideal candidates.
Not a fit: People not on ocrelizumab, those with EDSS ≥7.0, underweight or malnourished individuals, recent relapse or recent systemic steroid/surgery within exclusion windows, or those with prior lymphoablative therapies are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, results could show that GLP‑1 drugs used with ocrelizumab help slow disability progression and preserve walking and hand function in people with MS.
How similar studies have performed: GLP‑1 agonists have shown metabolic and neuroprotective signals in animal studies and some small human reports, but combining GLP‑1 therapy with ocrelizumab to affect PIRA in MS is largely novel and human evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.