What this trial means for you
This study is recruiting now at 1 US site. It's studying GLP-1, Ocrelizumab (US) for multiple sclerosis.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Illinois
- Northwestern Memorial Hospital — Chicago · Recruiting now
View the official record on ClinicalTrials.gov →
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