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Recruiting NCT07286175

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

Phase II Interventional Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brenipatide, Placebo.
Who it may be relevant to
Registry conditions: Bipolar Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Brazil, China, India +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug Brenipatide
    Administered SC
  • Drug Placebo
    Administered SC

Primary outcome measures

  • 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 outcome measures (9)
  • Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score [Time frame: Baseline, up to at least 6 months]
  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Time frame: Baseline, up to at least 6 months]
  • Change from Baseline in Young Mania Rating Scale (YMRS) Total Score [Time frame: Baseline, up to at least 6 months]
  • Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: Baseline, up to at least 6 months]
  • Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Time frame: Baseline, up to at least 6 months]
  • Number of Participants with Treatment-Emergent Anti-Drug Antibodies [Time frame: Baseline, up to at least 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 20 centers
  • ATP Clinical Research — Orange
  • Yale University School of Medicine — New Haven
  • AGA Clinical Trials — Hialeah
  • Accel Research Sites - Maitland Clinical Research Unit — Maitland
  • K2 Medical Research - Maitland — Maitland
  • Floridian Clinical Research, LLC — Miami Lakes
  • CLA Research — Naples
  • Charter Research - Orlando — Orlando
  • … and 12 more centers
Japan · 15 centers
  • Uematsu Mental Clinic — Chikugo
  • Jimbocho Mental Clinic — Chiyoda City
  • Horikoshi Mental Somatic Clinic — Fukushima
  • Saitama Medical University Hospital — Iruma
  • Rainbow and Sea Hospital — Karatsu
  • Monzen-nakacho Mental Clinic — Kōtō City
  • Suizenji Life Clinic — Kumamoto
  • Kure Medical Center — Kure
  • … and 7 more centers
India · 13 centers
  • Galaxy Superspeciality Hospital — Aurangabad
  • Belagavi Institute of Medical Sciences - Belagavi — Belgavi
  • All India Institute of Medical Sciences (AIIMS) - Bhopal — Bhopal
  • Society for Psychiatric Update and Research — Chhatrapati Sambhajinagar
  • Graphic Era Institute of Medical Sciences and Hospital — Dehradun
  • Dharwad Institute Of Mental Health And Neurosciences — Dharwad
  • Dr. Ram Manohar Lohia Institute of Medical Sciences — Lucknow
  • Career Institute of Medical Sciences and Hospital - Lucknow — Lucknow
  • … and 5 more centers
Argentina · 12 centers
  • Hospital Italiano de Buenos Aires — ABB
  • Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires
  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires
  • Stat Research S.A. — Buenos Aires
  • Mautalen Salud e Investigación — Buenos Aires
  • Instituto Médico DAMIC — Córdoba
  • Instituto Kremer — Córdoba
  • Centro Médico Luquez — Córdoba
  • … and 4 more centers
China · 10 centers
  • The Second People's Hospital of Hunan Province — Changsha
  • The Seventh People's Hospital of Hangzhou — Hangzhou
  • 3rd People's Hospital of Huzhou — Huzhou
  • Shangdong Mental Health Center — Jinan
  • Shanghai Mental Health Center — Shanghai
  • Shanghai Tongji Hospital — Shanghai
  • The First Hospital of Hebei Medical University — Shijiazhuang
  • Tianjin Anding Hospital — Tianjin
  • … and 2 more centers
Brazil · 9 centers
  • Chronos Pesquisa Clínica — Brasília
  • Instituto de Pesquisa clinica de Campinas — Campinas
  • Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
  • Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
  • Facili Centro Integrado de Psiquiatria — São Bernardo do Campo
  • CPQuali Pesquisa Clínica — São Paulo
  • BR Trials - Ensaios Clinicos e Consultoria — São Paulo
  • Clinica Viver - Centro de Desospitalizacao Humana — São Paulo
  • … and 1 more center
Mexico · 7 centers
  • Scientia Investigacion Clinica S.C. — Chihuahua City
  • … and 6 more centers
Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07286175 · 27365 · J2S-MC-GZMJ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗