Current partner codePEPTIDESDE
NCT07497399·Phase 2·INTERVENTIONAL

Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis

Status

Recruiting

Phase

Phase 2

Enrollment

120

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is 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). 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).

Interventions

Treatment arms and agents.

DRUG

NLY01

NLY01 is a pegylated exenatide

DRUG

Placebo

Placebo (saline solution)

Timeline

From registration to results.

  1. First posted

    Mar 27, 2026

  2. Study start

    Apr 28, 2026

  3. Primary completion

    Jan 2030

  4. Study completion

    Jan 2030

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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).

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.

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.

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),

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),

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

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.

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).

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

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
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 locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Johns Hopkins University

Baltimore, Maryland, United States

Mount Sinai School of Medicine

New York, New York, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.