A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study t... | EligiMed

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Aún no reclutaFase 2ClinicalTrials.gov

ID: NCT07410507Tipo: INTERVENTIONALInicio: 1 de feb de 2026Fin estimado: 1 de nov de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 55 YearsSexo: ALL

Criterios de inclusión

Meet the diagnostic criteria of schizophrenia
Are on a stable standard of care medication regimen for schizophrenia
If the duration of illness is \>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
self-inject study intervention store and use the provided study intervention as directed,
maintain electronic or paper study diaries, as applicable, and
complete the required questionnaires

Criterios de exclusión

Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
Are actively suicidal or deemed to be a significant risk for suicide
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Intervenciones

drug

Brenipatide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Centro Neurobiológico y de Estrés Traumático (CENydET)

Buenos Aires, Argentina

Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)

Buenos Aires, Argentina

Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

CEN Centro Especializado en Neurociencias

Córdoba, Argentina

Sanatorio Morra S.A.

Córdoba, Argentina

Instituto Kremer

Córdoba, Argentina

TAMARA YERCOVICH

Centro Médico Luquez

Córdoba, Argentina

INSA Instituto de Neurociencia San Agustin

La Plata, Argentina

Global Psy Asociación Civil

La Plata, Argentina

Hernan Alessandria

Resolution Psychopharmacology Research Institute

Mendoza, Argentina

Centro de Investigación y Asistencia en Psiquiatría (CIAP)

Rosario, Argentina

Fundacion Estudios Clinicos

Rosario, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.