NCT07207148Recruiting
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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 disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest. For Aim 2, the clinical trial, PIRA will be measured pre-GLP-1 start and at study end (week 72). A composite score of disability, similar to the ORATORIO13 trial will be constructed including EDSS score, 25-foot timed walk, 9-hole peg test, and SDMT score.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 15 Nov 2025
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Northwestern University
- Diseases
- Obesity, Multiple sclerosis
- NCT number
- NCT07207148
What you commit to
- Study type: Observational
- Planned participants: 100
- From 15 Nov 2025 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,
- Unclear documentation of MS diagnosis or prior or current MS treatment,
- Recent major surgical procedure in the past 6 months,
- Exposure to steroids (systemic) within the past 3 months,
Other illness
- Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, dementia, etc.),
Other
- Current clinical trial participant,
- Unable to speak a language for which translation can be found in the hospital system,
- Relapse within the past 3 months,
- Not on Ocrelizumab in the past \>9 months,
- Moribund status,
- Underweight or experiencing protein malnutrition,
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.