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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Administered SC
Administered SC
ATP Clinical Research
Orange, California, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGAGA Clinical Trials
Hialeah, Florida, United States
RECRUITINGAccel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, United States
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
Time frame: Randomization up to at least 6 months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time frame: Baseline, up to at least 6 months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline, up to at least 6 months
Change from Baseline in Young Mania Rating Scale (YMRS) Total Score
Time frame: Baseline, up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline, up to at least 6 months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline, up to at least 6 months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies
Time frame: Baseline, up to at least 6 months
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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K2 Medical Research - Maitland
Maitland, Florida, United States
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Miami Lakes, Florida, United States
RECRUITINGCLA Research
Naples, Florida, United States
RECRUITINGCharter Research - Orlando
Orlando, Florida, United States
RECRUITINGEncore Medical Research - Weston
Weston, Florida, United States
RECRUITINGAtlanta Center for Medical Research
Atlanta, Georgia, United States
RECRUITING...and 77 more locations