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Looks at whether GLP-1 drugs with ocrelizumab affect multiple sclerosis progression

Observes adults with multiple sclerosis taking ocrelizumab alongside GLP-1 drugs.

Key facts

Who runs it
Northwestern University
Where
Chicago, United StatesSee the site
Trial code
Registry title
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Status
Recruiting
People taking part
100 people, planned
Started
15 Nov 2025
Expected to end
31 Aug 2028
Type of study
Observational, 2 groups
Treatments tested
  • GLP-1
  • Ocrelizumab (US)
Record updated
17 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple sclerosis who have been treated with ocrelizumab and who have used, or are about to start, a GLP-1 agonist.

Age
18 to 70 years
Sex
All sexes can join
Disease stage
Multiple sclerosis of any type (PPMS, RRMS, SPMS), diagnosed by a neurologist, with EDSS below 7.0 and an MRI to confirm the diagnosis. BMI must be 24.0 kg/m2 or higher.
Earlier treatment
Must have taken at least one dose of Ocrelizumab before joining. Cannot have had Mavenclad, Lemtrada, Cyclophosphamide, a stem cell transplant or similar bone marrow suppressing treatment.

Main reasons for not taking part

  • Relapse in the past 3 months
  • Steroids (systemic) in the past 3 months
  • Major surgery in the past 6 months
  • Currently in another clinical trial
  • Underweight or protein malnutrition

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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,
  • Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, dementia, etc.),
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in United States

  • Northwestern Memorial HospitalChicago, United StatesContact: Dylan Rice, BATaking people

About the trial

What the trial wants to find out

The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Aim 1

    The cohort will implement patient-reported outcome measures (PROMs) in 60 people with MS already treated with both Ocrelizumab and a GLP-1 agonist to assess progression and ambulation, while recording drug tolerability and potential adverse events, weight loss, disease-based outcomes focused on progression, and MS-focused quality of life.

    Treatment: GLP-1 and Ocrelizumab (US)

  • Aim 2

    The cohort will include a single-arm, open-label trial of 40 Ocrelizumab-treated MS patients who are soon starting GLP-1 agonists, monitored prospectively for 2 years to measure MS progression (clinical disability worsening, stability or improvement) every 3 months, including (a) clinical assessments (e.g. EDSS, 25-foot timed walk, SDMT) as used in the ORATORIO trial of Ocrelizumab, (b) PROMs on progression in MS including fatigue, ambulation distance, mood; and (3) simple objective biomarkers of disease (e.g. plasma neurofilament light chain, glial fibrillary acidic protein).

    Treatment: GLP-1 and Ocrelizumab (US)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Plain-language title
Looks at whether GLP-1 drugs with ocrelizumab affect multiple sclerosis progressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07207148, who can take part
Record updated
17 March 2026