Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing NLY01 for Multiple Sclerosis

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).

Official registry: https://clinicaltrials.gov/study/NCT07497399 · Johns Hopkins University · enrollment listed as 120

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NLY01, or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 120 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: NLY01, Placebo

Primary outcome (registry wording): Change in normalized (for head size) brain parenchymal volume (nBPV)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 60 Years
  • Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI
  • Body mass index ≥27.0 kg/m2

Public study contact (from the registry)

Study Manager

667-306-8153

mvieira4@jh.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS).

NCT00794352 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

RecruitingPhase 1 / Phase 2Boston, Massachusetts
Phase 1 / Phase 2: testing [F-18]PBR06 for Multiple Sclerosis

The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.

NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

RecruitingPhase 3Palo Alto, California
Phase 3: testing Best Available Therapy (BAT) for Relapsing Multiple Sclerosis

This is a multi-center prospective rater-masked (blinded) randomly assigned controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). you would be randomly assigned at a 1 to 1 (1:1) ratio.

NCT04047628 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

FAQ about this NCT record

Is NCT07497399 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07497399?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07497399?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary