> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-brenipatide-in-adult-participants-with-bipolar-0fa91953-a9ab-43f2-9b6b-b0b830492032 > Record changed: 2026-11-04 # A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) NCT07286175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) Start date 2025-11-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) Number of sites 87 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Short title** A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Official title** A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Dates **Completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **First posted** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Registry last updated** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Primary completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Start date** 2025-11-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Number of sites** 87 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Identifiers **Registry ID** NCT07286175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **ClinicalTrials.gov ID** NCT07286175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Outcomes ### Primary outcomes 1. Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion Timeframe: Randomization up to at least 6 months ### Secondary outcomes 1. Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score Timeframe: Baseline, up to at least 6 months 2. Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Timeframe: Baseline, up to at least 6 months 3. Change from Baseline in Young Mania Rating Scale (YMRS) Total Score Timeframe: Baseline, up to at least 6 months 4. Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score Timeframe: Baseline, up to at least 6 months 5. Change from Baseline in Patient Rated Outcome as Measured by Patient's Global Impression of Severity (PGI-S) Timeframe: Baseline, up to at least 6 months 6. Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 Timeframe: Baseline, up to at least 6 months 7. Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 and on an Atypical Antipsychotic Timeframe: Baseline, up to at least 6 months 8. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide Timeframe: Baseline, up to at least 6 months 9. Number of Participants with Treatment-Emergent Anti-Drug Antibodies Timeframe: Baseline, up to at least 6 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Sites - ATP Clinical ResearchOrange, United StatesRecruiting - Yale University School of MedicineNew Haven, United StatesRecruiting - AGA Clinical TrialsHialeah, United StatesRecruiting - Accel Research Sites - Maitland Clinical Research UnitMaitland, United StatesRecruiting - K2 Medical Research - MaitlandMaitland, United StatesRecruiting - Floridian Clinical Research, LLCMiami Lakes, United StatesRecruiting - CLA ResearchNaples, United StatesRecruiting - Charter Research - OrlandoOrlando, United StatesRecruiting - Encore Medical Research - WestonWeston, United StatesRecruiting - Atlanta Center for Medical ResearchAtlanta, United StatesRecruiting - Covenant Medical CenterWaterloo, United StatesRecruiting - CBH HealthGaithersburg, United StatesRecruiting - Elixia MASpringfield, United StatesRecruiting - Adams Clinical WatertownWatertown, United StatesRecruiting - Penn Medicine: University of Pennsylvania Health SystemPhiladelphia, United StatesRecruiting - Revival Research Institute, LLCMcKinney, United StatesRecruiting - Pillar Clinical Research - RichardsonRichardson, United StatesRecruiting - Alpine Research OrganizationClinton, United StatesRecruiting - Re:Cognition HealthFairfax, United StatesRecruiting - Northwest Clinical Research CenterBellevue, United StatesRecruiting - Hospital Italiano de Buenos AiresABB, ArgentinaNot yet recruiting - Centro Neurobiológico y de Estrés Traumático (CENydET)Buenos Aires, ArgentinaRecruiting - Instituto Nacional de Psicopatología (INAPsi)- FunDaMosBuenos Aires, ArgentinaRecruiting - Stat Research S.A.Buenos Aires, ArgentinaNot yet recruiting - Mautalen Salud e InvestigaciónBuenos Aires, ArgentinaRecruiting And 62 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/674575) ### Other registry identifiers - J2S-MC-GZMJ Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07286175) ## Related records ### Drugs (1) - [Brenipatide](https://trialight.com/data/asset/brenipatide-4758d77a-80b3-5d20-93d3-fc5bfaf5857c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Bipolar disorder](https://trialight.com/data/condition/bipolar-disorder-a61ecd6f-6fb9-5323-bc0d-ebf861411d3c.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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