Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study

Official 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).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 120 participants

Interventions

• DRUG: NLY01 — NLY01 is a pegylated exenatide
• DRUG: Placebo — Placebo (saline solution)

Primary Outcomes

• Change in normalized (for head size) brain parenchymal volume (nBPV) (Baseline, week 48, and week 96)

Secondary Outcomes

• Change in normalized gray matter volume (mL) (Baseline, week 48, and week 96)
• Change in thalamic volume (mL) (Baseline, week 48, and week 96)
• Change in cortical thickness (mm) (Baseline, week 48, and week 96)
• Change in retinal nerve fiber layer thickness (Baseline, week 48, and week 96)
• Change in ganglion cell/inner plexiform thickness (Baseline, week 48, and week 96)

Trial Locations

• Johns Hopkins University, Baltimore, Maryland, United States

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