NCT07286175
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Recruiting
PHASE2Ages 18–75InterventionalTreatmentEli Lilly and Company
~400 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BrenipatidePlacebo
At a glance
Recruiting sites
78 of 87 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
Measured over Randomization up to at least 6 months
Conditions
Where it's being run
87 sites across 19 statesJapan15
India13
Argentina12
China10
Brazil9
Florida7
Mexico7
Massachusetts2
Study leadership
- Call 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 · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse CriterionRandomization up to at least 6 months