Status:
NOT_YET_RECRUITING
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Brief Summary
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not. For Aim 1, the cohort, patient-derived disab...
Detailed Description
STUDY PROCEDURES: Aim 1 will allow fully remote participation, drawing from geographically diverse settings throughout the USA. Participants in Aim 1 do not need to visit the study site in person or ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07207148
Start Date
December 15 2025
End Date
August 31 2028
Last Update
December 9 2025
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611