Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07286175

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Italiano de Buenos Aires, ABB, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brenipatide

Drug

Administered SC

Other names: LY3537031

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

  1. Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score

    Time frame: Baseline, up to at least 6 months

  2. Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    Time frame: Baseline, up to at least 6 months

  3. Change from Baseline in Young Mania Rating Scale (YMRS) Total Score

    Time frame: Baseline, up to at least 6 months

  4. Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, up to at least 6 months

  8. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Time frame: Baseline, up to at least 6 months

  9. Number of Participants with Treatment-Emergent Anti-Drug Antibodies

    Time frame: Baseline, up to at least 6 months

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.