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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07497399
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in normalized (for head size) brain parenchymal volume (nBPV) [ Time Frame: Baseline, week 48, and week 96 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Margaret Vieira
[email protected]
667-306-8153
Ellen Mowry, MD, MCR (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Johns Hopkins University· Baltimore, MD

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