Tests brenipatide with usual care in adults with bipolar disorder
Tests whether brenipatide added to usual care delays bipolar symptoms returning in adults.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Key facts
- Where
- Brasília, Campinas, Marília, Rio de Janeiro, São Bernardo do Campo, São Paulo, and Valinhos, BrazilSee the 9 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07286175, who can take part
Where in Brazil
- Chronos Pesquisa ClínicaBrasília, BrazilTaking people
- Instituto de Pesquisa Clínica de CampinasCampinas, BrazilTaking people
- Centro de Pesquisa Clínica de Marília - CPCLIMMarília, BrazilTaking people
- Ruschel Medicina e Pesquisa ClínicaRio de Janeiro, BrazilTaking people
- Facili - Centro Integrado de PsiquiatriaSão Bernardo do Campo, BrazilTaking people
- BR Trials-Ensaios Clinicos e ConsultoriaSão Paulo, BrazilTaking people
- Clinica Viver - Centro de Desospitalizacao HumanaSão Paulo, BrazilTaking people
- CPQuali Pesquisa ClínicaSão Paulo, BrazilTaking people
- A2Z Clinical Centro Avançado De Pesquisa Clínica - ValinhosValinhos, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07286175
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening; 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; 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; Are actively suicidal and or deemed to be at significant risk for suicide.