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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07286175

Registry updated: 2026-10-07
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Description

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

  • Brenipatide (Drug)
    Administered SC
  • Placebo (Drug)
    Administered SC

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

Conditions

Bipolar Disorder

Locations

  • ATP Clinical Research — Orange, California, United States
  • Yale University School of Medicine — New Haven, Connecticut, United States
  • AGA Clinical Trials — Hialeah, Florida, United States
  • Accel Research Sites - Maitland Clinical Research Unit — Maitland, Florida, United States
  • K2 Medical Research - Maitland — Maitland, Florida, United States
  • Floridian Clinical Research, LLC — Miami Lakes, Florida, United States
  • CLA Research — Naples, Florida, United States
  • Charter Research - Orlando — Orlando, Florida, United States
  • Encore Medical Research - Weston — Weston, Florida, United States
  • Atlanta Center for Medical Research — Atlanta, Georgia, United States
  • Covenant Medical Center — Waterloo, Iowa, United States
  • CBH Health — Gaithersburg, Maryland, United States
  • Elixia MA — Springfield, Massachusetts, United States
  • Adams Clinical Watertown — Watertown, Massachusetts, United States
  • Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
  • Revival Research Institute, LLC — McKinney, Texas, United States
  • Pillar Clinical Research - Richardson — Richardson, Texas, United States
  • Alpine Research Organization — Clinton, Utah, United States
  • Re:Cognition Health — Fairfax, Virginia, United States
  • Northwest Clinical Research Center — Bellevue, Washington, United States
  • Hospital Italiano de Buenos Aires — ABB, Argentina
  • Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires, Argentina
  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires, Argentina
  • Stat Research S.A. — Buenos Aires, Argentina
  • Mautalen Salud e Investigación — Buenos Aires, Argentina
  • Instituto Médico DAMIC — Córdoba, Argentina
  • Instituto Kremer — Córdoba, Argentina
  • Centro Médico Luquez — Córdoba, Argentina
  • Global Psy Asociación Civil — La Plata, Argentina
  • Fundacion Scherbovsky — Mendoza, Argentina
  • INECO Neurociencias Oroño — Rosario, Argentina
  • Clinica El Jardin — Santiago del Estero, Argentina
  • Chronos Pesquisa Clínica — Brasília, Brazil
  • Instituto de Pesquisa clinica de Campinas — Campinas, Brazil
  • Centro de Pesquisa Clínica de Marília - CPCLIM — Marília, Brazil
  • Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, Brazil
  • Facili Centro Integrado de Psiquiatria — São Bernardo do Campo, Brazil
  • CPQuali Pesquisa Clínica — São Paulo, Brazil
  • BR Trials - Ensaios Clinicos e Consultoria — São Paulo, Brazil
  • Clinica Viver - Centro de Desospitalizacao Humana — São Paulo, Brazil
  • A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos — Valinhos, Brazil
  • The Second People's Hospital of Hunan Province — Changsha, China
  • The Seventh People's Hospital of Hangzhou — Hangzhou, China
  • 3rd People's Hospital of Huzhou — Huzhou, China
  • Shangdong Mental Health Center — Jinan, China
  • Shanghai Mental Health Center — Shanghai, China
  • Shanghai Tongji Hospital — Shanghai, China
  • The First Hospital of Hebei Medical University — Shijiazhuang, China
  • Tianjin Anding Hospital — Tianjin, China
  • Xiamen Xianyue Hospital — Xiamen, China
  • Zhumadian Psychiatric Hospital — Zhumadian, China
  • Galaxy Superspeciality Hospital — Aurangabad, India
  • Belagavi Institute of Medical Sciences - Belagavi — Belgavi, India
  • All India Institute of Medical Sciences (AIIMS) - Bhopal — Bhopal, India
  • Society for Psychiatric Update and Research — Chhatrapati Sambhajinagar, India
  • Graphic Era Institute of Medical Sciences and Hospital — Dehradun, India
  • Dharwad Institute Of Mental Health And Neurosciences — Dharwad, India
  • Dr. Ram Manohar Lohia Institute of Medical Sciences — Lucknow, India
  • Career Institute of Medical Sciences and Hospital - Lucknow — Lucknow, India
  • Mysore Medical College — Mysore, India
  • Assured Care Plus Hospital — Nashik, India
  • Lifepoint Multispeciality Hospital — Pune, India
  • Sowmanasya Hospital and Institute of Psychiatry — Tiruchirappalli, India
  • Deva Institute Of Healthcare Research — Varanasi, India
  • Uematsu Mental Clinic — Chikugo, Japan
  • Jimbocho Mental Clinic — Chiyoda City, Japan
  • Horikoshi Mental Somatic Clinic — Fukushima, Japan
  • Saitama Medical University Hospital — Iruma, Japan
  • Rainbow and Sea Hospital — Karatsu, Japan
  • Monzen-nakacho Mental Clinic — Kōtō City, Japan
  • Suizenji Life Clinic — Kumamoto, Japan
  • Kure Medical Center — Kure, Japan
  • Hirota Clinic — Kurume, Japan
  • Yutaka Clinic — Sagamihara, Japan
  • Maynds Tower Mental Clinic — Shibuya-ku, Japan
  • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi — Tokyo, Japan
  • Ikebukuro Olive Mental Clinic — Toshima City, Japan
  • Yamagata Sakuracho Hospital — Yamagata, Japan
  • Miki Mental Clinic — Yokohama, Japan
  • Scientia Investigacion Clinica S.C. — Chihuahua City, Mexico
  • Clinica de Investigacion en Reumatologia y Obesidad S. C. — Guadalajara, Mexico
  • B&B Investigaciones Medicas S.C. — Mazatlán, Mexico
  • Centro de Investigación Clinica Chapultepec — Mexico City, Mexico
  • Ketamine Clinic México — Mexico City, Mexico
  • Medical Care and Research SA de CV — Mérida, Mexico
  • Centro de Investigacion Clinica Chapultepec — Morelia, Mexico
  • SCB Research Center — Bayamón, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record