Bipolar Disorder
Conditions
Brief 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.
Interventions
DRUGBrenipatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion | Randomization up to at least 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score | Baseline, up to at least 6 months |
| Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Baseline, up to at least 6 months |
| Change from Baseline in Young Mania Rating Scale (YMRS) Total Score | Baseline, up to at least 6 months |
| Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score | Baseline, up to at least 6 months |
| Change from Baseline in Patient Rated Outcome as Measured by Patient's Global Impression of Severity (PGI-S) | Baseline, up to at least 6 months |
| Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 | Baseline, up to at least 6 months |
| Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 and on an Atypical Antipsychotic | Baseline, up to at least 6 months |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide | Baseline, up to at least 6 months |
| Number of Participants with Treatment-Emergent Anti-Drug Antibodies | Baseline, up to at least 6 months |
Countries
Argentina, Brazil, China, India, Japan, Mexico, Puerto Rico, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed