Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT07207148

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

GLP-1

Ocrelizumab (US)

Study Details

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 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.

Conditions

Multiple Sclerosis

Study ID

NCT07207148

Start date

Nov 15, 2025

Status verified date

Mar, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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).

Interventions

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.

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 measure

  • PIRA [ Time Frame: From enrollment to the end of study at 72 weeks. ]

Central Contacts and Locations

Central contacts

Dylan Rice, BA

240-362-4800dylan.rice@northwestern.edu

Caroline Gebczak, BS

630-313-0470caroline.gebczak@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Dylan Rice, BA

240-362-4800dylan.rice@northwestern.edu

Caroline Gebczak, BS

630-313-0470caroline.gebczak@northwestern.edu

Principal Investigator:

Farrah J Mateen, MD, PhD

More Information

Sponsor

Northwestern University

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Ocrelizumab
  • GLP-1
  • Obesity
  • Weight loss
  • Progressive MS
  • Multiple sclerosis
  • Biomarkers
  • Weight
  • Overweight
  • Neuroprotection
  • Semaglutide
  • glucagon-like peptide-1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-17.