Actively Recruiting
A Phase 2 Study to Assess Brenipatide Added to Standard Care for Delaying Relapse in Adults With Bipolar Disorder
Led by Eli Lilly and Company · Updated on 2026-06-03
400
Participants Needed
87
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of brenipatide, given alongside standard care, compared to a placebo with standard care, in adults with bipolar disorder. This phase 2 study aims to assess how well brenipatide delays the worsening of bipolar symptoms and monitors its safety. The trial is sponsored by Eli Lilly and Company and includes adults aged 18 to 75 with bipolar disorder type I or II. Participants will be randomly assigned to one of three groups: two different doses of brenipatide or a placebo, all administered by subcutaneous injection along with their usual bipolar disorder treatment. The study consists of three periods: a screening period of about one month, a treatment period lasting at least six months, and a follow-up period of approximately two months. Treatment adherence and symptom changes will be closely monitored during these times. During the trial, participants will self-inject the study medication and keep electronic and paper diaries. Researchers will assess mental health through questionnaires and rating scales, such as the Montgomery-Åsberg Depression Rating Scale and Young Mania Rating Scale, along with quality of life and functional impairment measures. The main outcome is the time until relapse of bipolar symptoms. Safety will be observed throughout, with the total participation duration varying based on individual progress and willingness to continue.
CONDITIONS
Brief Title
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for bipolar disorder I or II
- Be reliable and willing to attend all study visits and follow procedures
- Be able and willing to self-inject the study medication
- Be able and willing to store and use the blinded study medication as directed
- Maintain electronic and paper study diaries as required
- Complete all required questionnaires
- Be on stable standard of care medication for bipolar disorder
You will not qualify if you...
- Have a lifetime or current diagnosis of schizophrenia, other psychotic disorder, borderline personality disorder, or any eating disorder
- Have type 1 diabetes mellitus or a history of ketoacidosis, hyperosmolar state, or coma
- Have moderate or severe substance or alcohol use disorder within 180 days before screening
- Be actively suicidal or at significant risk for suicide
- Have participated in a clinical study with active treatment within 90 days or 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to at least 6 months
Participants receive Brenipatide or placebo administered subcutaneously in addition to their standard care for bipolar disorder to delay relapse.
Regular visits during the treatment period
Trial Site Locations
Total: 87 locations
1
ATP Clinical Research
Orange, California, United States, 92866
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
3
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Actively Recruiting
4
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, United States, 32751
Actively Recruiting
5
K2 Medical Research - Maitland
Maitland, Florida, United States, 32751
Actively Recruiting
6
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016-1518
Actively Recruiting
7
CLA Research
Naples, Florida, United States, 34116
Actively Recruiting
8
Charter Research - Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
9
Encore Medical Research - Weston
Weston, Florida, United States, 33331
Actively Recruiting
10
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
11
Covenant Medical Center
Waterloo, Iowa, United States, 50702
Actively Recruiting
12
CBH Health
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
13
Elixia MA
Springfield, Massachusetts, United States, 01103
Actively Recruiting
14
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
15
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Revival Research Institute, LLC
McKinney, Texas, United States, 75071
Actively Recruiting
17
Pillar Clinical Research - Richardson
Richardson, Texas, United States, 75080
Actively Recruiting
18
Alpine Research Organization
Clinton, Utah, United States, 84015
Actively Recruiting
19
Re:Cognition Health
Fairfax, Virginia, United States, 22031
Actively Recruiting
20
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
21
Hospital Italiano de Buenos Aires
ABB, Argentina, C1199ABB
Not Yet Recruiting
22
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires, Argentina, 1058
Actively Recruiting
23
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires, Argentina, 1405
Actively Recruiting
24
Stat Research S.A.
Buenos Aires, Argentina, C1023AAB
Not Yet Recruiting
25
Mautalen Salud e Investigación
Buenos Aires, Argentina, C1128AAF
Not Yet Recruiting
26
Instituto Médico DAMIC
Córdoba, Argentina, X5003DCE
Not Yet Recruiting
27
Instituto Kremer
Córdoba, Argentina, X5004AOA
Not Yet Recruiting
28
Centro Médico Luquez
Córdoba, Argentina, X5006CBI
Not Yet Recruiting
29
Global Psy Asociación Civil
La Plata, Argentina, 1904
Not Yet Recruiting
30
Fundacion Scherbovsky
Mendoza, Argentina, 5500
Not Yet Recruiting
31
INECO Neurociencias Oroño
Rosario, Argentina, 2000
Not Yet Recruiting
32
Clinica El Jardin
Santiago del Estero, Argentina, 4200
Not Yet Recruiting
33
Chronos Pesquisa Clínica
Brasília, Brazil, 72145-450
Not Yet Recruiting
34
Instituto de Pesquisa clinica de Campinas
Campinas, Brazil, 13060-080
Not Yet Recruiting
35
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil, 17504-072
Not Yet Recruiting
36
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Not Yet Recruiting
37
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil, 09726-150
Not Yet Recruiting
38
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Not Yet Recruiting
39
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil, 01236030
Not Yet Recruiting
40
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, Brazil, 04020-060
Not Yet Recruiting
41
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, Brazil, 13271-130
Not Yet Recruiting
42
The Second People's Hospital of Hunan Province
Changsha, China, 410007
Actively Recruiting
43
The Seventh People's Hospital of Hangzhou
Hangzhou, China, 310000
Actively Recruiting
44
3rd People's Hospital of Huzhou
Huzhou, China, 313000
Actively Recruiting
45
Shangdong Mental Health Center
Jinan, China, 250012
Actively Recruiting
46
Shanghai Mental Health Center
Shanghai, China, 200030
Actively Recruiting
47
Shanghai Tongji Hospital
Shanghai, China, 200065
Actively Recruiting
48
The First Hospital of Hebei Medical University
Shijiazhuang, China, 050031
Actively Recruiting
49
Tianjin Anding Hospital
Tianjin, China, 300022
Actively Recruiting
50
Xiamen Xianyue Hospital
Xiamen, China, 361012
Actively Recruiting
51
Zhumadian Psychiatric Hospital
Zhumadian, China, 463000
Actively Recruiting
52
Galaxy Superspeciality Hospital
Aurangabad, India, 431001
Actively Recruiting
53
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, India, 590019
Not Yet Recruiting
54
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, India, 462024
Not Yet Recruiting
55
Society for Psychiatric Update and Research
Chhatrapati Sambhajinagar, India, 431005
Actively Recruiting
56
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, India, 248008
Not Yet Recruiting
57
Dharwad Institute Of Mental Health And Neurosciences
Dharwad, India, 580008
Not Yet Recruiting
58
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, India, 226010
Not Yet Recruiting
59
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, India, 226020
Not Yet Recruiting
60
Mysore Medical College
Mysore, India, 570001
Not Yet Recruiting
61
Assured Care Plus Hospital
Nashik, India, 422101
Not Yet Recruiting
62
Lifepoint Multispeciality Hospital
Pune, India, 411057
Actively Recruiting
63
Sowmanasya Hospital and Institute of Psychiatry
Tiruchirappalli, India, 620002
Not Yet Recruiting
64
Deva Institute Of Healthcare Research
Varanasi, India, 221005
Not Yet Recruiting
65
Uematsu Mental Clinic
Chikugo, Japan, 833-0041
Actively Recruiting
66
Jimbocho Mental Clinic
Chiyoda City, Japan, 101-0051
Not Yet Recruiting
67
Horikoshi Mental Somatic Clinic
Fukushima, Japan, 960-8053
Not Yet Recruiting
68
Saitama Medical University Hospital
Iruma, Japan, 350-0495
Actively Recruiting
69
Rainbow and Sea Hospital
Karatsu, Japan, 847-0031
Not Yet Recruiting
70
Monzen-nakacho Mental Clinic
Kōtō City, Japan, 135-0047
Actively Recruiting
71
Suizenji Life Clinic
Kumamoto, Japan, 862-0956
Not Yet Recruiting
72
Kure Medical Center
Kure, Japan, 737-0023
Actively Recruiting
73
Hirota Clinic
Kurume, Japan, 830-0033
Not Yet Recruiting
74
Yutaka Clinic
Sagamihara, Japan, 252-0303
Actively Recruiting
75
Maynds Tower Mental Clinic
Shibuya-ku, Japan, 151-0053
Actively Recruiting
76
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, Japan, 162-0843
Actively Recruiting
77
Ikebukuro Olive Mental Clinic
Toshima City, Japan, 170-0013
Actively Recruiting
78
Yamagata Sakuracho Hospital
Yamagata, Japan, 990-0045
Not Yet Recruiting
79
Miki Mental Clinic
Yokohama, Japan, 220-0023
Actively Recruiting
80
Scientia Investigacion Clinica S.C.
Chihuahua City, Mexico, 31203
Not Yet Recruiting
81
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Mexico, 44650
Not Yet Recruiting
82
B&B Investigaciones Medicas S.C.
Mazatlán, Mexico, 82103
Not Yet Recruiting
83
Centro de Investigación Clinica Chapultepec
Mexico City, Mexico, 04100
Not Yet Recruiting
84
Ketamine Clinic México
Mexico City, Mexico, 04100
Not Yet Recruiting
85
Medical Care and Research SA de CV
Mérida, Mexico, 97070
Not Yet Recruiting
86
Centro de Investigacion Clinica Chapultepec
Morelia, Mexico, 58260
Not Yet Recruiting
87
SCB Research Center
Bayamón, Puerto Rico, 00961
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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