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)
Eli Lilly and Company
Summary
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBrenipatide
Administered SC
- DrugPlacebo
Administered SC
Locations (88)
- ATP Clinical ResearchOrange, California
- Yale University School of MedicineNew Haven, Connecticut
- AGA Clinical TrialsHialeah, Florida
- Accel Research Sites - Maitland Clinical Research UnitMaitland, Florida
- K2 Medical Research - MaitlandMaitland, Florida
- Floridian Clinical Research, LLCMiami Lakes, Florida