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 2026-11-04.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 400 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 criteria:
Have type 1 diabetes mellitus, or a history of
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
Of 56 phase 2 interventional studies under Bipolar Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 60. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Brenipatide