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A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

400 patients around the world

Available in Puerto Rico, Argentina, United States, Mexico, Brazil

Eli Lilly and Company

22Research sites

400Patients around the world

This study is for people with

Bipolar disorder

To 75 Years

All Gender

: 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.
Self-inject study intervention.
Store and use the provided blinded study intervention, as directed.
Maintain electronic and paper study diaries, as applicable.
Complete the required questionnaires.
Are on stable standard of care medication for bipolar disorder.

: Have a lifetime history or current diagnosis of the following according to DSM-5 criteria.
Schizophrenia or other psychotic disorder.
Borderline personality disorder.
Any eating disorder.
Have type 1 diabetes mellitus, or a history of.
Ketoacidosis.
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.

Instituto Médico Damic S.R.L.

Av. Colón 2057, Córdoba

STAT Research - CABA

Av. Callao 875, CABA, Buenos Aires

CENYDET Centro Neurobiológico y de Estrés Traumático (Biopsychomedical Research Group S.R.L.)

Marcelo T de Alvear 768 - 4° "A" CABA - Ciudad Autónoma de Bs As 1058AAJ

Instituto Privado Kremer

Coronel Pringles 73, Córdoba

Centro Médico Luquez

Sargento Cabral 1385, Córdoba

Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza

José Federico Moreno 2760, Mendoza

INECO Neurociencias Oroño - Rosario

Bv. Oroño 1508, Rosario, Santa Fe

Hospital Italiano de Buenos Aires - CABA, Buenos Aires

Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH

Clinica El Jardín

San Juan 108, Santiago Del Estero

Fundación FunDaMos para la asistencia e investigación en psiquiatría

Campichuelo 215 CABA C1405BOA

SponsorEli Lilly and Company

Study typeInterventional

Conditions

Bipolar disorder

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07286175