Clinical trialNCT07286175RecruitingPhase 2Interventional

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

SponsorEli Lilly and CompanyEnrollment400Bipolar Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST
Eli Lilly and Company
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

87 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Hospital Italiano de Buenos Aires
ABB, Argentina
José Faccioli
Not, yet, recruiting
Centro Neurobiológico Y de Estrés Traumático (cenydet)
Buenos Aires, Argentina
Enrique Kuper
Recruiting
Instituto Nacional de Psicopatología (inapsi)- Fundamos
Buenos Aires, Argentina
Luis Mosca
Recruiting
Mautalen Salud E Investigación
Buenos Aires, Argentina
Bibiana Saravia
Recruiting
Stat Research S.A.
Buenos Aires, Argentina
Juan Ingelmo
Not, yet, recruiting
Centro Médico Luquez
Córdoba, Argentina
Juan Luquez
Recruiting
Instituto Kremer
Córdoba, Argentina
TAMARA YERCOVICH
Recruiting
Instituto Médico Damic
Córdoba, Argentina
Gerardo Garcia Bonetto
Recruiting
Global Psy Asociación Civil
La Plata, Argentina
Hernan Alessandria
Recruiting
Fundacion Scherbovsky
Mendoza, Argentina
Sebastián Rauek
Recruiting
Ineco Neurociencias Oroño
Rosario, Argentina
Dario Tavolini
Recruiting
Clinica El Jardin
Santiago del Estero, Argentina
Gaston Noriega
Recruiting

Brazil

Chronos Pesquisa Clínica
Brasília, Brazil
Monique Scalco
Recruiting
Instituto de Pesquisa Clinica de Campinas
Campinas, Brazil
Alexandre Comandule
Recruiting
Centro de Pesquisa Clínica de Marília - Cpclim
Marília, Brazil
Fernanda Guimarães
Recruiting
Ruschel Medicina E Pesquisa Clínica
Rio de Janeiro, Brazil
Sandra Ruschel
Not, yet, recruiting
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil
Cintia de Azevedo Marques Périco
Recruiting
Br Trials - Ensaios Clinicos E Consultoria
São Paulo, Brazil
Acioly Lacerda
Recruiting
Cpquali Pesquisa Clínica
São Paulo, Brazil
Moacyr Rosa
Recruiting
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, Brazil
CLAUDIANE DALTIO
Recruiting
A2z Clinical Centro Avançado de Pesquisa Clínica - Valinhos
Valinhos, Brazil
Caroline da Silva
Not, yet, recruiting

China

the Second People'S Hospital of Hunan Province
Changsha, China
Xuhui Zhou
Recruiting
the Seventh People'S Hospital of Hangzhou
Hangzhou, China
Tao Li
Recruiting
3rd People'S Hospital of Huzhou
Huzhou, China
Xiaocong Fei
Recruiting
Shangdong Mental Health Center
Jinan, China
Mengmeng Sun
Recruiting
Shanghai Mental Health Center
Shanghai, China
Xiaohua Liu
Recruiting
Shanghai Tongji Hospital
Shanghai, China
Yuan Shen
Recruiting
the First Hospital of Hebei Medical University
Shijiazhuang, China
Cuixia An
Recruiting
Tianjin Anding Hospital
Tianjin, China
Lina Wang
Recruiting
Xiamen Xianyue Hospital
Xiamen, China
Lei Shi
Recruiting
Zhumadian Psychiatric Hospital
Zhumadian, China
Jingli Wang
Recruiting

India

Galaxy Superspeciality Hospital
Aurangabad, India
Amol Deshmukh
Recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, India
Chandra Shekhar TR
Recruiting
All India Institute of Medical Sciences (aiims) - Bhopal
Bhopal, India
Tamonud Modak
Not, yet, recruiting
Society for Psychiatric Update and Research
Chhatrapati Sambhajinagar, India
Chinmay Barhale
Recruiting
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, India
Jeetpal Singh Rana
Not, yet, recruiting
Dharwad Institute of Mental Health and Neurosciences
Dharwad, India
Srinivas Kosgi
Not, yet, recruiting
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, India
Abbas Mehdi
Recruiting
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, India
Abdul Qadir Jilani
Recruiting
Mysore Medical College
Mysore, India
Narendra M.S.
Not, yet, recruiting

47 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BrenipatidePlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Nov 2025
Primary completion: 30 Nov 2027
Completion: 30 Nov 2027
Last update posted: 21 Aug 2026
Registered enrollment: 400
Registry id: NCT07286175

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.