Skip to content

Trial · Observational

RecruitingPhase not statedRegistry data

People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists

NCTNCT07207148 (opens ClinicalTrials.gov in a new tab)Other idSTU00224018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase not stated
Enrollment
100 participants (estimated)
Sponsor
Northwestern University · Other
Design
Not stated
Countries
1 country

United States

Start
15 Nov 2025
Primary completion
1 Apr 2028 (estimated)
Completion
31 Aug 2028 (estimated)
First posted
3 Oct 2025
Last update posted
17 Mar 2026
Conditions
Multiple Sclerosis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph –

    People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists

    NCT07207148

    15 Nov 2025 to est. 31 Aug 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • GLP-1Drug
  • Ocrelizumab (US)Drug

Arms2

  • Other

    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.

  • Other

    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).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. PIRA

    Time frame · From enrollment to the end of study at 72 weeks.

    Registry description

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

Secondary outcomes(1)

  1. Neurofilament light chain

    Time frame · From the start of Aim 2 to the end of treatment at 72 weeks.

    Registry description

    There will be blood draws in Aim 2's clinical trial population. Aim 1's observational, interactive cohort will have an optional blood draw component. In both cases, the blood tests will involve send out testing for neurofilament light chain and in Aim 2, glial fibrillary acidic protein.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

20 results

Glucagon-like peptide-1 receptor agonists for the treatment of obstructive sleep apnea: a meta-analysis.

Li et al. 2025Sleepcited by 32

PMID 39626095DOI 10.1093/sleep/zsae280PUB-39626095

Full text at the publisher20 results
Publisher pageSee results (20)

Indexing hint: Randomized controlled trial · 2024

5 results

Trial of Lixisenatide in Early Parkinson's Disease.

Meissner et al. 2024The New England journal of medicinecited by 298

PMID 38598572DOI 10.1056/nejmoa2312323PUB-38598572

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2023

2 results

Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.

Lincoff et al. 2023The New England journal of medicinecited by 2,458

PMID 37952131DOI 10.1056/nejmoa2307563PUB-37952131

Rights unknown2 results
Source linkSee results (2)

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results
Publisher pageSee results (10)

More studies

1 study on this page

Indexing hint: Animal study · 2023

Semaglutide, a novel glucagon-like peptide-1 agonist, amends experimental autoimmune encephalomyelitis-induced multiple sclerosis in mice: Involvement of the PI3K/Akt/GSK-3β pathway.

Sadek et al. 2023International immunopharmacologycited by 54

PMID 36584570DOI 10.1016/j.intimp.2022.109647PUB-36584570

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.