A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07286175Tipo: INTERVENTIONALInicio: 24 de nov de 2025Fin 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 with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II
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 blinded study intervention, as directed
maintain electronic and paper study diaries, as applicable, and
complete the required questionnaires
Are on stable standard of care medication for bipolar disorder

Criterios de exclusión

Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:
schizophrenia or other psychotic disorder
borderline personality disorder, or
any eating disorder
Have type 1 diabetes mellitus, or a history of
ketoacidosis, or
hyperosmolar state or coma
Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
Are actively suicidal and or deemed to be at significant risk for suicide
Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Intervenciones

drug

Brenipatide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Hospital Italiano de Buenos Aires

ABB, Argentina

José Faccioli

NOT_YET_RECRUITING

Centro Neurobiológico y de Estrés Traumático (CENydET)

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

Buenos Aires, Argentina

NOT_YET_RECRUITING

Stat Research S.A.

Buenos Aires, Argentina

NOT_YET_RECRUITING

Mautalen Salud e Investigación

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto Médico DAMIC

Córdoba, Argentina

NOT_YET_RECRUITING

Instituto Kremer

Córdoba, Argentina

TAMARA YERCOVICH

NOT_YET_RECRUITING

Centro Médico Luquez

Córdoba, Argentina

NOT_YET_RECRUITING

Global Psy Asociación Civil

La Plata, Argentina

Hernan Alessandria

NOT_YET_RECRUITING

Fundacion Scherbovsky

Mendoza, Argentina

NOT_YET_RECRUITING

INECO Neurociencias Oroño

Rosario, Argentina

NOT_YET_RECRUITING

Clinica El Jardin

Santiago del Estero, Argentina

NOT_YET_RECRUITING

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.

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