Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Study Manager
mvieira4@jh.edu
667-306-8153
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2030-01
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Multiple Sclerosis Society, Race to Erase MS
Leads: Johns Hopkins University