Last updated 14 days ago

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

1000 patients around the world

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

Eli Lilly and Company

15Research sites

1000Patients around the world

This study is for people with

Depression

Major depression

To 75 Years

All Gender

: Meet the diagnostic criteria for major depressive disorder.
Are on a stable standard of care medication for major depressive disorder.
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.

: Have a lifetime history or current diagnosis of the following.
Schizophrenia or other psychotic disorder.
Bipolar disorder.
Borderline personality disorder.
Any eating disorder.
Have type 1 diabetes mellitus, or a history of.
Ketoacidosis.
Hyperosmolar state or coma.
Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening.
Are actively suicidal or deemed a 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.

Hospital Das Clínicas Da Universidade Federal de Minas Gerais - UFMG

Av. Prof. Alfredo Balena, 110 2 floor - Room 216 - Santa Efigênia, Belo Horizonte - MG, 30130-100

Trial Tech Tecnologia Em Pesquisas com Medicamentos LTDA

Rua Candido Xavier 425 Curitiba - Estado de Paraná 80.240-280

Clinilive - Maringá

R. Arthur Thomas, 806 - Centro, Maringá - PR, 87013-250, Brazil

Hospital Universitário Onofre Lopes - HUOL

Av. Nilo Peçanha, 620 - Petrópolis, Natal - RN, 59012-300, Brazil

Ruschel Medicina e Pesquisa Clínica

Rua Guilhermina Guinle 151 - Estado de Río de Janeiro 22270-060

Facili Centro Integrado de Saúde Mental

Av. Antártico, 381 - Sala 121 - Jardim do Mar, São Bernardo do Campo - SP, 09726-150, Brazil

CPQuali Pesquisa Clínica

Avenida Angélica, 916 Conjunto 506 - São Paulo 01228-000

CPClin – Centro de Pesquisas Clinicas LTDA

Avenida Angélica, 2162 – Consolação – São Paulo, SP, CEP:01228-200

BR Trials - Pesquisa Clínica - Sao Paulo

Av. Arnolfo Azevedo, 40 - Pacaembu, São Paulo - SP, 01236-030, Brazil

Scientia Investigacion Clinica S.C.

C. Sierra de la Campana 3701, Plaza del Sol, 31207 Chihuahua, Chih., Mexico

StudyRENEW-MDD-1

SponsorEli Lilly and Company

Study typeInterventional

Conditions

Major depression

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07412756