Multiple SclerosisNCT07207148
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
An observational study of Multiple Sclerosis, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- GLP-1 and Ocrelizumab (US)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with multiple sclerosis already treated with both Ocrelizumab and are either currently on a GLP-1 agonist or who are soon starting a GLP-1 agonist.
Who may be able to join
- 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 join
- 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,
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Dylan Rice, BA, 240-362-4800, dylan.rice@northwestern.edu
Caroline Gebczak, BS, 630-313-0470, caroline.gebczak@northwestern.edu
About this study
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.
Read the detailed description
STUDY PROCEDURES:
Aim 1 will allow fully remote participation, drawing from geographically diverse settings throughout the USA. Participants in Aim 1 do not need to visit the study site in person or be independently mobile but must be continuously available during the study timeframe remotely for PROMS and study surveys and calls.
Participants will be enrolled for an estimated 72 weeks: Measurements will be requested every four weeks (i.e. q28 days) on a specifically designed survey instrument for MS participants. Participants will be asked to report medication dosing, adherence to medicine, tolerability, weight, height, and exercise activities. Self-reported scales will be administered to the participants as well (measuring disability, fatigue, mood, and quality of life).
Participants must be currently on Ocrelizumab (last dose within the past <6 months) and currently taking a GLP-1 medication.
Participants will be contacted and interviewed via Zoom every 6 months to ensure study procedures are going as planned, verify data reported on medication and MS disease history, and ensure study procedures are operating smoothly. Participants who do not complete the surveys within 7 days of the scheduled timing will be contacted by a study coordinator by phone up to 3 times. Participants will also be asked to report any medication changes, dose changes, or discontinuations if they occur at any point between study visits.
Participants will be enrolled until a total of 40 individual participants are reached. Study procedures for each group are listed in Tables 1 and 2. All scheduled events will be part of the study and not part of routine clinical care.
Allocation and Blinding
All participants will be treated with the two drugs of interest: Ocrelizumab and the GLP-1 agonist. The participants will be blinded to the study outcome of interest, i.e. progression or PIRA. The investigators will not be blinded to the study outcome. The participants will not have access to their prior PDDS scores on file, earlier in the study. The EDSS raters will not have access to the prior EDSS scores on file, earlier in the study. The statisticians will not be blinded to the study outcome.
Criteria for Study Drug Discontinuation in a Single Participant
Reasons for GLP-1 agonist drug discontinuation will be at the discretion of the treating prescriber include: (1) laboratory test abnormalities (e.g. transaminitis) whether related to the drugs or not; (2) intercurrent illness; (3) severe intolerance to the GLP-1 agonist; (4) lack of access to the GLP-1 drug within an affordable range; (5) patient preference; (6) achieved weight target earlier than anticipated; or (7) any other reason as determined by the prescribing physician or study principal investigator.
Criteria for Study Withdrawal of a Participant
Participants who discontinue GLP-1 agonist drugs for any reason, including tolerability, cost, desired weight loss outcome, etc., will continue to be observed until the end of the study period. It is possible that participants will have periods of discontinuation and then resume GLP-1 agonist treatment. The participant will be observed until (a) week 72 visit (i.e. end of study period), (b) participant withdrawal with no consent to continue monitoring, or (c) investigator-decided withdrawal of a participant from the study (e.g. severe medical illness preventing study completion, departure far from study site, etc.).
There is no anticipated drug development or future product anticipated in this study. A study participant will not have any right to compensation or ownership interest related to such development.
- Conditions
- Multiple Sclerosis
- Being tested
- GLP-1, Ocrelizumab (US)
- Keywords
- Ocrelizumab, GLP-1, Obesity, Weight loss, Progressive MS, Multiple sclerosis, Biomarkers, Weight, Overweight, Neuroprotection, Semaglutide, glucagon-like peptide-1
- Medical subject headings
- Multiple Sclerosis, Obesity, Weight Loss, Body Weight, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called Glucagon-like peptide-1, GLP-1 Agonist
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)Drug
Also called Ocrevus
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GLP-1; Drug: 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). Receives: Drug: GLP-1; Drug: Ocrelizumab (US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIRA
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.
Measured: From enrollment to the end of study at 72 weeks.
Secondary outcomes (1)
Neurofilament light chain
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.
Measured: From the start of Aim 2 to the end of treatment at 72 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Nov 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Farrah Mateen, Northwestern University
- Investigators
- Farrah J Mateen, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207148
- Sponsor's protocol ID
- STU00224018
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharrad D, Chugh P, Slee M, Bacchi S. Defining progression independent of relapse activity (PIRA) in adult patients with relapsing multiple sclerosis: A systematic review✰. Mult Scler Relat Disord. 2023 Oct;78:104899. doi: 10.1016/j.msard.2023.104899. Epub 2023 Jul 20.
PubMed 37499338Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.
PubMed 28002688Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
PubMed 6685237Diz-Chaves Y, Maastor Z, Spuch C, Lamas JA, Gonzalez-Matias LC, Mallo F. Glucagon-like peptide 1 receptor activation: anti-inflammatory effects in the brain. Neural Regen Res. 2024 Aug 1;19(8):1671-1677. doi: 10.4103/1673-5374.389626. Epub 2023 Dec 11.
PubMed 38103230Sadek MA, Kandil EA, El Sayed NS, Sayed HM, Rabie MA. Semaglutide, a novel glucagon-like peptide-1 agonist, amends experimental autoimmune encephalomyelitis-induced multiple sclerosis in mice: Involvement of the PI3K/Akt/GSK-3beta pathway. Int Immunopharmacol. 2023 Feb;115:109647. doi: 10.1016/j.intimp.2022.109647. Epub 2022 Dec 28.
PubMed 36584570Udawatta M, Fidalgo N, Mateen FJ. Multiple sclerosis patients taking glucagon-like peptide-1 receptor (GLP-1) agonists: a single-institution retrospective cohort study of tolerability and weight loss. Neurol Sci. 2025 Jan;46(1):343-349. doi: 10.1007/s10072-024-07701-7. Epub 2024 Jul 20.
PubMed 39030327Li M, Lin H, Yang Q, Zhang X, Zhou Q, Shi J, Ge F. Glucagon-like peptide-1 receptor agonists for the treatment of obstructive sleep apnea: a meta-analysis. Sleep. 2025 Apr 11;48(4):zsae280. doi: 10.1093/sleep/zsae280.
PubMed 39626095Meissner WG, Remy P, Giordana C, Maltete D, Derkinderen P, Houeto JL, Anheim M, Benatru I, Boraud T, Brefel-Courbon C, Carriere N, Catala H, Colin O, Corvol JC, Damier P, Dellapina E, Devos D, Drapier S, Fabbri M, Ferrier V, Foubert-Samier A, Frismand-Kryloff S, Georget A, Germain C, Grimaldi S, Hardy C, Hopes L, Krystkowiak P, Laurens B, Lefaucheur R, Mariani LL, Marques A, Marse C, Ory-Magne F, Rigalleau V, Salhi H, Saubion A, Stott SRW, Thalamas C, Thiriez C, Tir M, Wyse RK, Benard A, Rascol O; LIXIPARK Study Group. Trial of Lixisenatide in Early Parkinson's Disease. N Engl J Med. 2024 Apr 4;390(13):1176-1185. doi: 10.1056/NEJMoa2312323.
PubMed 38598572Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.
PubMed 37952131Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
PubMed 33567185Fitzgerald KC, Salter A, Tyry T, Fox RJ, Cutter G, Marrie RA. Measures of general and abdominal obesity and disability severity in a large population of people with multiple sclerosis. Mult Scler. 2020 Jul;26(8):976-986. doi: 10.1177/1352458519845836. Epub 2019 May 13.
PubMed 31079537Hedstrom AK, Brenner N, Butt J, Hillert J, Waterboer T, Olsson T, Alfredsson L. Overweight/obesity in young adulthood interacts with aspects of EBV infection in MS etiology. Neurol Neuroimmunol Neuroinflamm. 2020 Dec 15;8(1):e912. doi: 10.1212/NXI.0000000000000912. Print 2021 Jan.
PubMed 33465039Mandato C, Colucci A, Lanzillo R, Staiano A, Scarpato E, Schiavo L, Operto FF, Serra MR, Di Monaco C, Napoli JS, Massa G, Vajro P. Multiple Sclerosis-Related Dietary and Nutritional Issues: An Updated Scoping Review with a Focus on Pediatrics. Children (Basel). 2023 Jun 7;10(6):1022. doi: 10.3390/children10061022.
PubMed 37371254Lutfullin I, Eveslage M, Bittner S, Antony G, Flaskamp M, Luessi F, Salmen A, Gisevius B, Klotz L, Korsukewitz C, Berthele A, Groppa S, Then Bergh F, Wildemann B, Bayas A, Tumani H, Meuth SG, Trebst C, Zettl UK, Paul F, Heesen C, Kuempfel T, Gold R, Hemmer B, Zipp F, Wiendl H, Lunemann JD; German Competence Network Multiple Sclerosis (KKNMS). Association of obesity with disease outcome in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):57-61. doi: 10.1136/jnnp-2022-329685. Epub 2022 Nov 1.
PubMed 36319190
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
- ClinicalTrials.gov ID
- NCT07207148
- Acronym / sponsor ID
- STU00224018
- Conditions
- Multiple Sclerosis
- Keywords
- Ocrelizumab, GLP-1, Obesity, Weight loss, Progressive MS, Multiple sclerosis, Biomarkers, Weight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY PROCEDURES:
Aim 1 will allow fully remote participation, drawing from geographically diverse settings throughout the USA. Participants in Aim 1 do not need to visit the study site in person or be independently mobile but must be continuously available during the study timeframe remotely for PROMS and study surveys and calls.
Participants will be enrolled for an estimated 72 weeks: Measurements will be requested every four weeks (i.e. q28 days) on a specifically designed survey instrument for MS participants. Participants will be asked to report medication dosing, adherence to medicine, tolerability, weight, height, and exercise activities. Self-reported scales will be administered to the participants as well (measuring disability, fatigue, mood, and quality of life).
Participants must be currently on Ocrelizumab (last dose within the past <6 months) and currently taking a GLP-1 medication.
Participants will be contacted and interviewed via Zoom every 6 months to ensure study procedures are going as planned, verify data reported on medication and MS disease history, and ensure study procedures are operating smoothly. Participants who do not complete the surveys within 7 days of the scheduled timing will be contacted by a study coordinator by phone up to 3 times. Participants will also be asked to report any medication changes, dose changes, or discontinuations if they occur at any point between study visits.
Participants will be enrolled until a total of 40 individual participants are reached. Study procedures for each group are listed in Tables 1 and 2. All scheduled events will be part of the study and not part of routine clinical care.
Allocation and Blinding
All participants will be treated with the two drugs of interest: Ocrelizumab and the GLP-1 agonist. The participants will be blinded to the study outcome of interest, i.e. progression or PIRA. The investigators will not be blinded to the study outcome. The participants will not have access to their prior PDDS scores on file, earlier in the study. The EDSS raters will not have access to the prior EDSS scores on file, earlier in the study. The statisticians will not be blinded to the study outcome.
Criteria for Study Drug Discontinuation in a Single Participant
Reasons for GLP-1 agonist drug discontinuation will be at the discretion of the treating prescriber include: (1) laboratory test abnormalities (e.g. transaminitis) whether related to the drugs or not; (2) intercurrent illness; (3) severe intolerance to the GLP-1 agonist; (4) lack of access to the GLP-1 drug within an affordable range; (5) patient preference; (6) achieved weight target earlier than anticipated; or (7) any other reason as determined by the prescribing physician or study principal investigator.
Criteria for Study Withdrawal of a Participant
Participants who discontinue GLP-1 agonist drugs for any reason, including tolerability, cost, desired weight loss outcome, etc., will continue to be observed until the end of the study period. It is possible that participants will have periods of discontinuation and then resume GLP-1 agonist treatment. The participant will be observed until (a) week 72 visit (i.e. end of study period), (b) participant withdrawal with no consent to continue monitoring, or (c) investigator-decided withdrawal of a participant from the study (e.g. severe medical illness preventing study completion, departure far from study site, etc.).
There is no anticipated drug development or future product anticipated in this study. A study participant will not have any right to compensation or ownership interest related to such development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | – | Drug: GLP-1, Drug: Ocrelizumab (US)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 | – | Drug: GLP-1, Drug: Ocrelizumab (US)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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with multiple sclerosis already treated with both Ocrelizumab and are either currently on a GLP-1 agonist or who are soon starting a GLP-1 agonist.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1Also: Glucagon-like peptide-1, GLP-1 AgonistGlucagon-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 | Aim 1, Aim 2 |
| Ocrelizumab (US)Also: OcrevusAll 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. | Drug | Aim 1, Aim 2 |
Primary outcome
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.
1 secondary outcome
Neurofilament light chain
Time frame: From the start of Aim 2 to the end of treatment at 72 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 37499338Sharrad D, Chugh P, Slee M, Bacchi S. Defining progression independent of relapse activity (PIRA) in adult patients with relapsing multiple sclerosis: A systematic review✰. Mult Scler Relat Disord. 2023 Oct;78:104899. doi: 10.1016/j.msard.2023.104899. Epub 2023 Jul 20.
- Background: PubMed 28002688Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.
- Background: PubMed 6685237Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
- Background: PubMed 38103230Diz-Chaves Y, Maastor Z, Spuch C, Lamas JA, Gonzalez-Matias LC, Mallo F. Glucagon-like peptide 1 receptor activation: anti-inflammatory effects in the brain. Neural Regen Res. 2024 Aug 1;19(8):1671-1677. doi: 10.4103/1673-5374.389626. Epub 2023 Dec 11.
- Background: PubMed 36584570Sadek MA, Kandil EA, El Sayed NS, Sayed HM, Rabie MA. Semaglutide, a novel glucagon-like peptide-1 agonist, amends experimental autoimmune encephalomyelitis-induced multiple sclerosis in mice: Involvement of the PI3K/Akt/GSK-3beta pathway. Int Immunopharmacol. 2023 Feb;115:109647. doi: 10.1016/j.intimp.2022.109647. Epub 2022 Dec 28.
- Background: PubMed 39030327Udawatta M, Fidalgo N, Mateen FJ. Multiple sclerosis patients taking glucagon-like peptide-1 receptor (GLP-1) agonists: a single-institution retrospective cohort study of tolerability and weight loss. Neurol Sci. 2025 Jan;46(1):343-349. doi: 10.1007/s10072-024-07701-7. Epub 2024 Jul 20.
- Background: PubMed 39626095Li M, Lin H, Yang Q, Zhang X, Zhou Q, Shi J, Ge F. Glucagon-like peptide-1 receptor agonists for the treatment of obstructive sleep apnea: a meta-analysis. Sleep. 2025 Apr 11;48(4):zsae280. doi: 10.1093/sleep/zsae280.
- Background: PubMed 38598572Meissner WG, Remy P, Giordana C, Maltete D, Derkinderen P, Houeto JL, Anheim M, Benatru I, Boraud T, Brefel-Courbon C, Carriere N, Catala H, Colin O, Corvol JC, Damier P, Dellapina E, Devos D, Drapier S, Fabbri M, Ferrier V, Foubert-Samier A, Frismand-Kryloff S, Georget A, Germain C, Grimaldi S, Hardy C, Hopes L, Krystkowiak P, Laurens B, Lefaucheur R, Mariani LL, Marques A, Marse C, Ory-Magne F, Rigalleau V, Salhi H, Saubion A, Stott SRW, Thalamas C, Thiriez C, Tir M, Wyse RK, Benard A, Rascol O; LIXIPARK Study Group. Trial of Lixisenatide in Early Parkinson's Disease. N Engl J Med. 2024 Apr 4;390(13):1176-1185. doi: 10.1056/NEJMoa2312323.
- Background: PubMed 37952131Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.
- Background: PubMed 33567185Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
- Background: PubMed 31079537Fitzgerald KC, Salter A, Tyry T, Fox RJ, Cutter G, Marrie RA. Measures of general and abdominal obesity and disability severity in a large population of people with multiple sclerosis. Mult Scler. 2020 Jul;26(8):976-986. doi: 10.1177/1352458519845836. Epub 2019 May 13.
- Background: PubMed 33465039Hedstrom AK, Brenner N, Butt J, Hillert J, Waterboer T, Olsson T, Alfredsson L. Overweight/obesity in young adulthood interacts with aspects of EBV infection in MS etiology. Neurol Neuroimmunol Neuroinflamm. 2020 Dec 15;8(1):e912. doi: 10.1212/NXI.0000000000000912. Print 2021 Jan.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farrah J Mateen principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dylan Rice, BA (240-362-4800, dylan.rice@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIRA (time frame: From enrollment to the end of study at 72 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207148, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.