A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
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)
- Bipolar Disorder
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 400
- Started
- 24 November 2025
- Main results due
- November 2027
- Study sites
- 87
- Registry updated
- 22 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(87)
ATP Clinical Research
Orange, California, United States
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Recruiting
AGA Clinical Trials
Hialeah, Florida, United States
Recruiting
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, United States
Recruiting
K2 Medical Research - Maitland
Maitland, Florida, United States
Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Recruiting
CLA Research
Naples, Florida, United States
Recruiting
Charter Research - Orlando
Orlando, Florida, United States
Recruiting
Encore Medical Research - Weston
Weston, Florida, United States
Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Recruiting
Covenant Medical Center
Waterloo, Iowa, United States
Recruiting
CBH Health
Gaithersburg, Maryland, United States
Recruiting
Elixia MA
Springfield, Massachusetts, United States
Recruiting
Adams Clinical Watertown
Watertown, Massachusetts, United States
Recruiting
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Recruiting
Revival Research Institute, LLC
McKinney, Texas, United States
Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Recruiting
Alpine Research Organization
Clinton, Utah, United States
Recruiting
Re:Cognition Health
Fairfax, Virginia, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting
Hospital Italiano de Buenos Aires
ABB, Argentina
Not yet recruiting
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires, Argentina
Recruiting
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires, Argentina
Recruiting
Stat Research S.A.
Buenos Aires, Argentina
Not yet recruiting
Mautalen Salud e Investigación
Buenos Aires, Argentina
Recruiting
Instituto Médico DAMIC
Córdoba, Argentina
Recruiting
Instituto Kremer
Córdoba, Argentina
Recruiting
Centro Médico Luquez
Córdoba, Argentina
Recruiting
Global Psy Asociación Civil
La Plata, Argentina
Recruiting
Fundacion Scherbovsky
Mendoza, Argentina
Recruiting
INECO Neurociencias Oroño
Rosario, Argentina
Recruiting
Clinica El Jardin
Santiago del Estero, Argentina
Recruiting
Chronos Pesquisa Clínica
Brasília, Brazil
Recruiting
Instituto de Pesquisa clinica de Campinas
Campinas, Brazil
Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil
Recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil
Recruiting
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil
Recruiting
CPQuali Pesquisa Clínica
São Paulo, Brazil
Recruiting
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil
Recruiting
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, Brazil
Recruiting
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, Brazil
Recruiting
The Second People's Hospital of Hunan Province
Changsha, China
Recruiting
The Seventh People's Hospital of Hangzhou
Hangzhou, China
Recruiting
3rd People's Hospital of Huzhou
Huzhou, China
Recruiting
Shangdong Mental Health Center
Jinan, China
Recruiting
Shanghai Mental Health Center
Shanghai, China
Recruiting
Shanghai Tongji Hospital
Shanghai, China
Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, China
Recruiting
Tianjin Anding Hospital
Tianjin, China
Recruiting
Xiamen Xianyue Hospital
Xiamen, China
Recruiting
Zhumadian Psychiatric Hospital
Zhumadian, China
Recruiting
Galaxy Superspeciality Hospital
Aurangabad, India
Recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, India
Recruiting
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, India
Recruiting
Society for Psychiatric Update and Research
Chhatrapati Sambhajinagar, India
Recruiting
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, India
Not yet recruiting
Dharwad Institute Of Mental Health And Neurosciences
Dharwad, India
Not yet recruiting
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, India
Recruiting
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, India
Recruiting
Mysore Medical College
Mysore, India
Not yet recruiting
Showing 60 of 87 sites — filter to narrow it down. 81 of the 87 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07286175. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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