A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

NCT07286175
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Eli Lilly and Company
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Start date
2025-11-24
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Number of sites
87
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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.
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Short title
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
clinicaltrials.gov
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-11-01
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First posted
2025-12-16
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Registry last updated
2026-10-07
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Primary completion date
2027-11-01
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Start date
2025-11-24
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
0
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Number of sites
87
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07286175
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ClinicalTrials.gov ID
NCT07286175
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • J2S-MC-GZMJ
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)