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.
Phase 2 trials begin testing efficacy in a larger patient group (100–300). This is often where biotech binary events occur — positive Phase 2 data can significantly advance a company's pipeline narrative, while failures can be terminal for a program.
Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.
Eli Lilly and Company (LLY) is the sponsoring company for this trial. BiotechSign currently grades this company C (54/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.