Bipolar DisorderPhase 2NCT07286175
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
A Phase 2 study testing Brenipatide in people with Bipolar Disorder, run by Eli Lilly and Company at 87 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Brenipatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 87 sitesin 8 countries
- Study dates
- 24 Nov 2025to Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
87 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
87 sites in 8 countries
United States20 sites, 20 recruiting
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Elyssa Barron
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
425-453-0404
Wisam Al jumaili
- Recruiting
Alpine Research Organization
Clinton, Utah, 84015
801-928-3292
Michael Roundy
- Recruiting
Re:Cognition Health
Fairfax, Virginia, 22031
Scott Williams
- Recruiting
CBH Health
Gaithersburg, Maryland, 20877
301-251-4702
Elia Acevedo Diaz
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012
3058196990 X 1
WILSON CUEVA
- Recruiting
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751
386-785-2400
Andrea Marraffino
- Recruiting
K2 Medical Research - Maitland
Maitland, Florida, 32751
Sejal Patel
- Recruiting
Revival Research Institute, LLC
McKinney, Texas, 75071
Jawad Riaz
- Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016-1518
305-330-9977
Hortensia Valeron
- Recruiting
CLA Research
Naples, Florida, 34116
239-837-8818
Evelia Iglesias
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06519
203-932-5711
Mohini Ranganathan
- Recruiting
ATP Clinical Research
Orange, California, 92866
949-354-5353
Gustavo Alva
- Recruiting
Charter Research - Orlando
Orlando, Florida, 32803
Jorel Martinez
- Recruiting
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Yvette Sheline
- Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
214-396-4844
Scott Bartley
- Recruiting
Elixia MA
Springfield, Massachusetts, 01103
413-305-1142
Susan Smiga
- Recruiting
Covenant Medical Center
Waterloo, Iowa, 50702
319-272-2112
NICHOLAS GOETSCH
- Recruiting
Adams Clinical Watertown
Watertown, Massachusetts, 02472
617-744-8542
Dyanna Domilici
- Recruiting
Encore Medical Research - Weston
Weston, Florida, 33331
954-777-8827
Luis Marchany Alfonso
Japan15 sites, 15 recruiting
- Recruiting
Uematsu Mental Clinic
Chikugo, 833-0041
81120023812
Ken Uematsu
- Recruiting
Jimbocho Mental Clinic
Chiyoda City, 101-0051
81120023812
Koji Tada
- Recruiting
Horikoshi Mental Somatic Clinic
Fukushima, 960-8053
81120023812
Sho Horikoshi
- Recruiting
Saitama Medical University Hospital
Iruma, 350-0495
81120023812
Koji Matsuo
- Recruiting
Rainbow and Sea Hospital
Karatsu, 847-0031
81120023812
Taro Shindo
- Recruiting
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047
81120023812
Junpei Sekiya
- Recruiting
Suizenji Life Clinic
Kumamoto, 862-0956
81120023812
Tomohiko Matsuo
- Recruiting
Kure Medical Center
Kure, 737-0023
81120023812
Wataru Omori
- Recruiting
Hirota Clinic
Kurume, 830-0033
81120023812
Susumu Hirota
- Recruiting
Yutaka Clinic
Sagamihara, 252-0303
81120023812
Hideo Muraoka
- Recruiting
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
81120023812
Nobutoshi Kariya
- Recruiting
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, 162-0843
81120023812
Seiji Hongo
- Recruiting
Ikebukuro Olive Mental Clinic
Toshima City, 170-0013
81120023812
Sachie Matsushima
- Recruiting
Yamagata Sakuracho Hospital
Yamagata, 990-0045
81120023812
Nobuhiro Yokokawa
- Recruiting
Miki Mental Clinic
Yokohama, 220-0023
81120023812
Kazuhira Miki
India13 sites, 13 recruiting
- Recruiting
Galaxy Superspeciality Hospital
Aurangabad, 431001
Amol Deshmukh
- Recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, 590019
Chandra Shekhar TR
- Recruiting
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, 462024
Tamonud Modak
- Recruiting
Society for Psychiatric Update and Research
Chhatrapati Sambhajinagar, 431005
+91-9823012123
Chinmay Barhale
- Not yet recruiting
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, 248008
Jeetpal Singh Rana
- Not yet recruiting
Dharwad Institute Of Mental Health And Neurosciences
Dharwad, 580008
Srinivas Kosgi
- Recruiting
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010
Abdul Qadir Jilani
- Recruiting
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, 226020
Abbas Mehdi
- Not yet recruiting
Mysore Medical College
Mysore, 570001
9633254370
Narendra M.S.
- Recruiting
Assured Care Plus Hospital
Nashik, 422101
Nakul Vanjari
- Recruiting
Lifepoint Multispeciality Hospital
Pune, 411057
Nitin Dalaya
- Not yet recruiting
Sowmanasya Hospital and Institute of Psychiatry
Tiruchirappalli, 620002
Gopalakrishnan Ganesan
- Recruiting
Deva Institute Of Healthcare Research
Varanasi, 221005
+91-9935571052
Venu Jhanwar
Argentina12 sites, 12 recruiting
- Not yet recruiting
Hospital Italiano de Buenos Aires
ABB, C1199ABB
José Faccioli
- Recruiting
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires, 1058
+5411 4313 4916
Enrique Kuper
- Recruiting
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires, 1405
+5491156257810
Luis Mosca
- Not yet recruiting
Stat Research S.A.
Buenos Aires, C1023AAB
+ 5491132613392
Juan Ingelmo
- Recruiting
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
541145143400
Bibiana Saravia
- Recruiting
Instituto Médico DAMIC
Córdoba, X5003DCE
+5493517352774
Gerardo Garcia Bonetto
- Recruiting
Instituto Kremer
Córdoba, X5004AOA
TAMARA YERCOVICH
- Recruiting
Centro Médico Luquez
Córdoba, X5006CBI
+5493517481586
Juan Luquez
- Recruiting
Global Psy Asociación Civil
La Plata, 1904
Hernan Alessandria
- Recruiting
Fundacion Scherbovsky
Mendoza, 5500
+5492615799019
Sebastián Rauek
- Recruiting
INECO Neurociencias Oroño
Rosario, 2000
5493416154466
Dario Tavolini
- Recruiting
Clinica El Jardin
Santiago del Estero, 4200
+5493854027710
Gaston Noriega
China10 sites, 10 recruiting
- Recruiting
The Second People's Hospital of Hunan Province
Changsha, 410007
Xuhui Zhou
- Recruiting
The Seventh People's Hospital of Hangzhou
Hangzhou, 310000
Tao Li
- Recruiting
3rd People's Hospital of Huzhou
Huzhou, 313000
Xiaocong Fei
- Recruiting
Shangdong Mental Health Center
Jinan, 250012
Mengmeng Sun
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
Xiaohua Liu
- Recruiting
Shanghai Tongji Hospital
Shanghai, 200065
Yuan Shen
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
Cuixia An
- Recruiting
Tianjin Anding Hospital
Tianjin, 300022
Lina Wang
- Recruiting
Xiamen Xianyue Hospital
Xiamen, 361012
Lei Shi
- Recruiting
Zhumadian Psychiatric Hospital
Zhumadian, 463000
Jingli Wang
Brazil9 sites, 9 recruiting
- Recruiting
Chronos Pesquisa Clínica
Brasília, 72145-450
+55 61 98208-4248
Monique Scalco
- Recruiting
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
Alexandre Comandule
- Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
5511944404464
Fernanda Guimarães
- Recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
55 21 35979708
Sandra Ruschel
- Recruiting
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150
+55 11 99399-0508
Cintia de Azevedo Marques Périco
- Recruiting
CPQuali Pesquisa Clínica
São Paulo, 01228-000
+55 (11) 2776-6801
Moacyr Rosa
- Recruiting
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030
1126722734
Acioly Lacerda
- Recruiting
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, 04020-060
+55 11 99892-9840
CLAUDIANE DALTIO
- Recruiting
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, 13271-130
Caroline da Silva
Mexico7 sites, 7 recruiting
- Recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31203
Rafael Fernández
- Recruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
Aura Garcia Aguilar
- Recruiting
B&B Investigaciones Medicas S.C.
Mazatlán, 82103
52 669 146 3603
GABRIEL BERNAL
- Recruiting
Medical Care and Research SA de CV
Mérida, 97070
Enrique Lara González
- Recruiting
Centro de Investigación Clinica Chapultepec
Mexico City, 04100
ARACELI MARTINEZ-ESTRADA
- Recruiting
Ketamine Clinic México
Mexico City, 04100
55 15454240
MANUEL RUIZ FLORES
- Recruiting
Centro de Investigacion Clinica Chapultepec
Morelia, 58260
Misael Tapia Orozco
Puerto Rico1 site, 1 recruiting
- Recruiting
SCB Research Center
Bayamón, 00961
(787) 798-4592
William Julio
About this study
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)
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.
- Conditions
- Bipolar Disorder
- Being tested
- Brenipatide, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Brenipatide administered subcutaneous (SC) + SoC. Receives: Drug: Brenipatide |
| Brenipatide Dose 2 . | Experimental | Brenipatide administered subcutaneous (SC) + SoC. Receives: Drug: Brenipatide |
| Placebo | Placebo comparator | Placebo administered SC + SoC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
Measured: Randomization up to at least 6 months
Secondary outcomes (9)
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Measured: Baseline, up to at least 6 months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Measured: Baseline, up to at least 6 months
Change from Baseline in Young Mania Rating Scale (YMRS) Total Score
Measured: Baseline, up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline, up to at least 6 months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Baseline, up to at least 6 months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies
Measured: Baseline, up to at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start24 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286175
- Sponsor's protocol ID
- 27365
- Other IDs
- J2S-MC-GZMJ
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.