A Phase 2 interventional study of Brenipatide and Placebo in Bipolar Disorder, sponsored by Eli Lilly and Company. Recruiting at 87 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
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
Exclusion Criteria:
Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:
Have type 1 diabetes mellitus, or a history of
Brenipatide administered subcutaneous (SC) + SoC.
Drug: Brenipatide
Brenipatide administered subcutaneous (SC) + SoC.
Drug: Brenipatide
Placebo administered SC + SoC.
Drug: Placebo
Administered SC
Also known as: LY3537031
Administered SC
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
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eli Lilly and Company