NCT07207148 · Northwestern University
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
What this study is about
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 group of participants, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest.
View original scientific description
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.
Interventions
DRUG
GLP-1
Glucagon-like peptide-1 agonist agent is the study agent of interest. This study will not supply the GLP-1 drug but depends on the patient's clinical prescription of this drug.
DRUG
Ocrelizumab (US)
All participants will be treated with Ocrelizumab for the indication of MS; however, the study will not provide Ocrelizumab as it will be part of the participant's routine clinical care.
Primary outcome measures
PIRA
Time frame: From enrollment to the end of study at 72 weeks.
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations