A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
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)
2 other identifiers
interventional
400
8 countries
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2025
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
June 3, 2026
June 1, 2026
1.9 years
November 21, 2025
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
Randomization up to at least 6 months
Secondary Outcomes (9)
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
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
- +4 more secondary outcomes
Study Arms (3)
Brenipatide Dose 1
EXPERIMENTALBrenipatide administered subcutaneous (SC) + SoC.
Brenipatide Dose 2 .
EXPERIMENTALBrenipatide administered subcutaneous (SC) + SoC.
Placebo
PLACEBO COMPARATORPlacebo administered SC + SoC.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
ATP Clinical Research
Orange, California, 92866, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751, United States
K2 Medical Research - Maitland
Maitland, Florida, 32751, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016-1518, United States
CLA Research
Naples, Florida, 34116, United States
Charter Research - Orlando
Orlando, Florida, 32803, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
CBH Health
Gaithersburg, Maryland, 20877, United States
Elixia MA
Springfield, Massachusetts, 01103, United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Revival Research Institute, LLC
McKinney, Texas, 75071, United States
Pillar Clinical Research - Richardson
Richardson, Texas, 75080, United States
Alpine Research Organization
Clinton, Utah, 84015, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Hospital Italiano de Buenos Aires
ABB, C1199ABB, Argentina
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires, 1058, Argentina
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires, 1405, Argentina
Stat Research S.A.
Buenos Aires, C1023AAB, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Instituto Médico DAMIC
Córdoba, X5003DCE, Argentina
Instituto Kremer
Córdoba, X5004AOA, Argentina
Centro Médico Luquez
Córdoba, X5006CBI, Argentina
Global Psy Asociación Civil
La Plata, 1904, Argentina
Fundacion Scherbovsky
Mendoza, 5500, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Clinica El Jardin
Santiago del Estero, 4200, Argentina
Chronos Pesquisa Clínica
Brasília, 72145-450, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060, Brazil
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030, Brazil
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, 04020-060, Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, 13271-130, Brazil
The Second People's Hospital of Hunan Province
Changsha, 410007, China
The Seventh People's Hospital of Hangzhou
Hangzhou, 310000, China
3rd People's Hospital of Huzhou
Huzhou, 313000, China
Shangdong Mental Health Center
Jinan, 250012, China
Shanghai Mental Health Center
Shanghai, 200030, China
Shanghai Tongji Hospital
Shanghai, 200065, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
Tianjin Anding Hospital
Tianjin, 300022, China
Xiamen Xianyue Hospital
Xiamen, 361012, China
Zhumadian Psychiatric Hospital
Zhumadian, 463000, China
Galaxy Superspeciality Hospital
Aurangabad, 431001, India
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, 590019, India
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, 462024, India
Society for Psychiatric Update and Research
Chhatrapati Sambhajinagar, 431005, India
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, 248008, India
Dharwad Institute Of Mental Health And Neurosciences
Dharwad, 580008, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010, India
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, 226020, India
Mysore Medical College
Mysore, 570001, India
Assured Care Plus Hospital
Nashik, 422101, India
Lifepoint Multispeciality Hospital
Pune, 411057, India
Sowmanasya Hospital and Institute of Psychiatry
Tiruchirappalli, 620002, India
Deva Institute Of Healthcare Research
Varanasi, 221005, India
Uematsu Mental Clinic
Chikugo, 833-0041, Japan
Jimbocho Mental Clinic
Chiyoda City, 101-0051, Japan
Horikoshi Mental Somatic Clinic
Fukushima, 960-8053, Japan
Saitama Medical University Hospital
Iruma, 350-0495, Japan
Rainbow and Sea Hospital
Karatsu, 847-0031, Japan
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047, Japan
Suizenji Life Clinic
Kumamoto, 862-0956, Japan
Kure Medical Center
Kure, 737-0023, Japan
Hirota Clinic
Kurume, 830-0033, Japan
Yutaka Clinic
Sagamihara, 252-0303, Japan
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053, Japan
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, 162-0843, Japan
Ikebukuro Olive Mental Clinic
Toshima City, 170-0013, Japan
Yamagata Sakuracho Hospital
Yamagata, 990-0045, Japan
Miki Mental Clinic
Yokohama, 220-0023, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31203, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650, Mexico
B&B Investigaciones Medicas S.C.
Mazatlán, 82103, Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, 04100, Mexico
Ketamine Clinic México
Mexico City, 04100, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260, Mexico
SCB Research Center
Bayamón, 00961, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 16, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.