Testing NLY01 to Slow Brain Shrinkage in Multiple Sclerosis
Tests NLY01 against placebo for slowing nerve damage in people with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Key facts
- Where
- Baltimore, Kansas City, and New York, United StatesSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07497399, who can take part
Where in United States
- Johns Hopkins UniversityBaltimore, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Mount Sinai School of MedicineNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT07497399
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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; 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; 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:; 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; No concerns about candidacy of individual on part of person's neurologist or study team clinicians; 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:; 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.