Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS)

May 4, 2026 updated by: Johns Hopkins University

Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study

The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).

Researchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Ellen Mowry, MD, MCR
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI
  • Aged 18-60 years
  • Body mass index ≥27.0 kg/m2

Exclusion Criteria:

  • No GLP-1RA or GIP/GLP-1 RA in past year; no known hypersensitivity to medication class
  • No known Barrett's esophagus/gastroesophageal reflux disease, pancreatitis (including past), or gastroparesis
  • No personal/family history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2
  • No chronic kidney disease (estimated glomerular filtration rate ≤50 mL/min) in past year, type 1 diabetes, known diabetic retinopathy, use of insulin or insulin-inducing medications*, dipeptidyl peptidase IV inhibitors**, or warfarin; current/active alcohol or illicit substance abuse
  • No concerns about candidacy of individual on part of person's neurologist or study team clinicians

  • Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)***

    • currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone/glimepiride) & meglitinide analogues (nateglinide and repaglinide); ** currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin ***Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of <1%/year, or two methods of lesser effectiveness:

Contraceptive methods with a failure rate of < 1% per year includes the following:

  • Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD
  • Complete abstinence from sexual encounters with a person who has testes

Those who do not wish to use one of the above methods of contraception must use two methods. Options include:

  • Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.

  • Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:

    • A condom with or without spermicide

    • A cap, diaphragm, or sponge with or without spermicide

      • Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo (saline solution)
Active Comparator: NLY01 (Study Drug)
5 mg subcutaneous weekly for the first 4 weeks, then 10 mg subcutaneous weekly, with pre-planned dose adjustments if adverse events prevent full dosage.
Drug: NLY01
NLY01 is a pegylated exenatide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in normalized (for head size) brain parenchymal volume (nBPV)
Time Frame: Baseline, week 48, and week 96
Change in normalized (for head size) nBPV (mL). Measured from randomization to end of treatment (approximately 96 weeks). Presented as mean and standard deviation
Baseline, week 48, and week 96

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in normalized gray matter volume (mL)
Time Frame: Baseline, week 48, and week 96
Presented as mean and standard deviation Measured from randomization to end of treatment (approximately 96 weeks).
Baseline, week 48, and week 96
Change in thalamic volume (mL)
Time Frame: Baseline, week 48, and week 96
Measured from randomization to end of treatment (up to 96 weeks). Presented as mean and standard deviation.
Baseline, week 48, and week 96
Change in cortical thickness (mm)
Time Frame: Baseline, week 48, and week 96
Measured from randomization to end of treatment (approximately 96 weeks), Presented as mean and standard deviation.
Baseline, week 48, and week 96
Change in retinal nerve fiber layer thickness
Time Frame: Baseline, week 48, and week 96
Measured in μm, from randomization to end of treatment (approximately 96 weeks),
Baseline, week 48, and week 96
Change in ganglion cell/inner plexiform thickness
Time Frame: Baseline, week 48, and week 96
Measured in μm, from randomization to end of treatment (approximately 96 weeks),
Baseline, week 48, and week 96
Disability progression as assessed by the Expanded Disability Status Scale (EDSS)
Time Frame: Approximately every 24 weeks, up to 96 weeks
Expanded Disability Status Scale (EDSS). Scale range 0-10; higher score is worse disability progression
Approximately every 24 weeks, up to 96 weeks
Disability progression as assessed by the Multiple Sclerosis Functional Composite (MSFC)
Time Frame: Approximately every 24 weeks, up to 96 weeks
The Multiple Sclerosis Functional Composite (MSFC) calculates a single Z-score from tests of ambulation, arm dexterity, and cognition. Scores are converted to a z score with a mean and standard deviation. A higher Z-score indicates better function.
Approximately every 24 weeks, up to 96 weeks
Disability progression as assessed by the Expanded Disability Status Scale-Plus
Time Frame: Approximately every 24 weeks, up to 96 weeks
The EDSS-plus allows for documentation of progression as a composite value, considering progression as having occurred if any one of the following occurs: 20% increase in timed 25-foot walk or 9-hole peg test, or a 1.0-point increase in EDSS (if baseline is 5.5 or less) or a 0.5-point increase (if baseline is >5.5).
Approximately every 24 weeks, up to 96 weeks
Patient-reported disability progression as assessed by the Patient-Determined Disease Steps
Time Frame: Approximately every 24 weeks, up to 96 weeks
Patient-Determined Disease Steps score range 0-8; higher is worse progression
Approximately every 24 weeks, up to 96 weeks
Change in self-reported anxiety as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Anxiety Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Anxiety Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported depression as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Depression Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Depression Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported fatigue as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Fatigue Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Fatigue Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported upper extremity function as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Upper Extremity Function Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Upper Extremity Function Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported lower extremity function as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Lower Extremity Function Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Lower Extremity Function Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported cognitive function as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in positive affect/well-being as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Positive Affect/Well-being Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Positive Affect/Well-being Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported sleep disturbance as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Sleep Disturbance Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Sleep Disturbance Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported ability to participate in social roles Quality of Life in Neurological Disorders (Neuro-QOL) Ability to Participate in Social Roles Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Ability to Participate in Social Roles Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Change in self-reported stigma as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Stigma Subscale
Time Frame: Approximately every 24 weeks, up to 96 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Stigma Subscale. Higher scores indicate more of the domain; distribution of T-Score has a mean of 50, standard deviation of 10.
Approximately every 24 weeks, up to 96 weeks
Adverse events
Time Frame: From randomization to week 96
Proportion of individuals in each arm experiencing adverse events
From randomization to week 96
Serious adverse events
Time Frame: From randomization to week 96
Proportion of individuals in each arm experiencing serious adverse events
From randomization to week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Multiple Sclerosis Society
Race to Erase MS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ellen M Mowry, MD, MCR, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00454859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in this publication, along with the protocol and analysis plan, will be available upon reasonable request to qualified researchers. Requests must include a proposal and are contingent on meeting regulatory approvals, including a signed data use agreement.

IPD Sharing Time Frame

Data will be available 6 months after publication and remain accessible for 12-24 months.

IPD Sharing Access Criteria

Qualified researchers who have completed and signed approvals for data sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on NLY01

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings