NLY01 for Multiple Sclerosis
This study is looking into whether a drug called NLY01 can help people with Multiple Sclerosis (MS) by reducing inflammation and slowing down brain and eye damage. NLY01 is a pegylated exenatide. Researchers will compare NLY01 to a placebo (a saline solution) to see if it can reduce the shrinking of the brain, measured by MRI scans. You might be able to join if you are 18-60 years old, have MS, and have a BMI of 27 or higher. The study aims to enroll 120 participants. The current status of this study is unclear.
- Study design
- This study will compare NLY01 to a placebo in 120 participants. Participants will be randomly assigned to receive either NLY01 or the placebo.
- What's involved
- Brain MRI scans will be performed at the start of the study, at week 48, and at week 96.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 96 weeks (about 2 years) to measure changes in brain volume.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07497399
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Recruiting
PHASE2Ages 18–60InterventionalTreatmentJohns Hopkins UniversityInvestigator-initiated
~120 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:NLY01Placebo
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in normalized (for head size) brain parenchymal volume (nBPV)
Measured over Baseline, week 48, and week 96
Conditions
Where it's being run
2 sites across 2 statesMaryland1
New York1
Study leadership
- Ellen M Mowry, MD, MCR · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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
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:
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
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.
What this trial measures
- Change in normalized (for head size) brain parenchymal volume (nBPV)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