Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorJohns Hopkins University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
NLY01
DrugNLY01 is a pegylated exenatide
Placebo
DrugPlacebo (saline solution)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: NLY01 (Study Drug)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in normalized (for head size) brain parenchymal volume (nBPV)
Change in normalized (for head size) nBPV (mL). Measured from randomization to end of treatment (approximately 96 weeks). Presented as mean and standard deviation
Time frame
Baseline, week 48, and week 96Secondary outcomes
1
Change in normalized gray matter volume (mL)
Presented as mean and standard deviation Measured from randomization to end of treatment (approximately 96 weeks).
Time frame
Baseline, week 48, and week 962
Change in thalamic volume (mL)
Measured from randomization to end of treatment (up to 96 weeks). Presented as mean and standard deviation.
Time frame
Baseline, week 48, and week 963
Change in cortical thickness (mm)
Measured from randomization to end of treatment (approximately 96 weeks), Presented as mean and standard deviation.
Time frame
Baseline, week 48, and week 964
Change in retinal nerve fiber layer thickness
Measured in μm, from randomization to end of treatment (approximately 96 weeks),
Time frame
Baseline, week 48, and week 96Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Multiple Sclerosis Society
Collaborator
Race to Erase MS
Collaborator
Source ClinicalTrials.gov