ReclutandoNCT07497399Registro de ClinicalTrials.gov

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

Multiple Sclerosis

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 60 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 120 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

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

Exclusion Criteria:

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
No concerns about candidacy of individual on part of person's neurologist or study team clinicians
Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)\*\*\*

currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone/glimepiride) \& meglitinide analogues (nateglinide and repaglinide); \*\* currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin \*\*\*Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of \<1%/year, or two methods of lesser effectiveness:

Contraceptive methods with a failure rate of \< 1% per year includes the following:

Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD
Complete abstinence from sexual encounters with a person who has testes

Those who do not wish to use one of the above methods of contraception must use two methods. Options include:

Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.
Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:

A condom with or without spermicide
A cap, diaphragm, or sponge with or without spermicide

Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

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.

Drug: NLY01

Placebo

No informado en este registro.

Drug: Placebo

NLY01 DRUG

NLY01 is a pegylated exenatide

Placebo DRUG

Placebo (saline solution)

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change in normalized (for head size) brain parenchymal volume (nBPV)

Plazo: Baseline, week 48, and week 96

Change in normalized (for head size) nBPV (mL). Measured from randomization to end of treatment (approximately 96 weeks). Presented as mean and standard deviation

Medidas secundarias

Change in normalized gray matter volume (mL)

Plazo: Baseline, week 48, and week 96

Presented as mean and standard deviation Measured from randomization to end of treatment (approximately 96 weeks).

Change in thalamic volume (mL)

Plazo: Baseline, week 48, and week 96

Measured from randomization to end of treatment (up to 96 weeks). Presented as mean and standard deviation.

Change in cortical thickness (mm)

Plazo: Baseline, week 48, and week 96

Measured from randomization to end of treatment (approximately 96 weeks), Presented as mean and standard deviation.

Change in retinal nerve fiber layer thickness

Plazo: Baseline, week 48, and week 96

Measured in μm, from randomization to end of treatment (approximately 96 weeks),

Change in ganglion cell/inner plexiform thickness

Plazo: Baseline, week 48, and week 96

Measured in μm, from randomization to end of treatment (approximately 96 weeks),

Disability progression as assessed by the Expanded Disability Status Scale (EDSS)