A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
ConditionBipolar Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
schizophrenia or other psychotic disorder
borderline personality disorder, or
any eating disorder
Have type 1 diabetes mellitus, or a history of
Trial design
Treatments tested in this trial
- Brenipatide
- Placebo
Treatment groups
400 Participants
are divided into 3 treatment groupsLocations
87Argentina
Hospital Italiano de Buenos AiresC1199ABB, ABB Argentina
Centro Neurobiológico y de Estrés Traumático (CENydET)1058, Buenos Aires Argentina
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos1405, Buenos Aires Argentina
Mautalen Salud e InvestigaciónC1128AAF, Buenos Aires Argentina
Sponsors and collaborators
Eli Lilly and Company
Lead sponsor
Source ClinicalTrials.gov