Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Purpose
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).
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Johns Hopkins University
Baltimore, Maryland 21287
Baltimore, Maryland 21287
More Details
- Status
- Recruiting
- Sponsor
- Johns Hopkins University