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New treatment option for Multiple Sclerosis
Official title Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
ClinicalTrials.gov ID: NCT07497399
What this study is testing
What is NLY01?
NLY01 is an investigational medicine, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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...
- 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 (±...
- Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.