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Clinical Trials/NCT07286175
NCT07286175
Recruiting
Phase 2

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)

Eli Lilly and Company170 sites in 5 countries400 target enrollmentStarted: November 24, 2025Last updated:
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InterventionsBrenipatidePlacebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
400
Locations
170
Primary Endpoint
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Brenipatide Dose 2 .

Experimental

Brenipatide administered subcutaneous (SC) + SoC.

Intervention: Brenipatide (Drug)

Placebo

Placebo Comparator

Placebo administered SC + SoC.

Intervention: Placebo (Drug)

Brenipatide Dose 1

Experimental

Brenipatide administered subcutaneous (SC) + SoC.

Intervention: Brenipatide (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2(Baseline, up to at least 6 months)
  • Change from Baseline in Young Mania Rating Scale (YMRS) Total Score(Baseline, up to at least 6 months)
  • Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score(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)(Baseline, up to at least 6 months)
  • Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score(Baseline, up to at least 6 months)
  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(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(Baseline, up to at least 6 months)
  • Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline, up to at least 6 months)
  • Number of Participants with Treatment-Emergent Anti-Drug Antibodies(Baseline, up to at least 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (170)

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