Actively Recruiting
A Phase 2 Study to Investigate the Efficacy and Safety of Brenipatide as an Add-On Treatment in Adults With Schizophrenia
Led by Eli Lilly and Company · Updated on 2026-06-03
450
Participants Needed
102
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of brenipatide when given alongside standard care compared to a placebo plus standard care for adults with schizophrenia. This Phase 2, double-blind study aims to better understand if adding brenipatide can affect symptoms and other health factors in people living with this condition. The study is sponsored by Eli Lilly and Company and includes participants aged 18 to 55 who meet specific diagnostic criteria and treatment stability requirements. Participants will be randomly assigned to receive either brenipatide or a placebo, both administered by subcutaneous injection alongside their usual standard of care treatments. The study spans three main periods: a screening period of about 1 month, a treatment period lasting up to 12 months, and a follow-up period of approximately 2 months. During these times, participants will receive the assigned injections and continue with their standard treatment routines. Throughout the study, participants will attend regular visits where researchers will assess changes in body weight, cognition, schizophrenia symptoms, and overall health using various scales and tests. They will also monitor for any immune responses to the treatment and track any relapses or changes in severity. The total duration of participation may last up to about 15 months, with careful safety and efficacy monitoring during and after treatment.
CONDITIONS
Brief Title
A Study of Brenipatide in Adult Participants With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria of schizophrenia
- Are on a stable standard of care medication regimen for schizophrenia
- If illness duration is over 6 years, have experienced at least one relapse in the last 3 years
- Have at least one reliable study partner such as a family member or healthcare worker
- Are reliable and willing to attend study visits, self-inject the study drug, keep study diaries, and complete questionnaires
You will not qualify if you...
- Have a lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
- Have moderate or severe substance or alcohol use disorder within 180 days before screening
- Have type 1 diabetes or a history of ketoacidosis, hyperosmolar state, or coma
- Are actively suicidal or considered at significant risk for suicide
- Are currently enrolled in another clinical study with an investigational product or incompatible medical research
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.
Duration - Up to 52 weeks
Participants receive Brenipatide or placebo as an add-on treatment to their standard of care medication for schizophrenia.
Trial Site Locations
Total: 102 locations
1
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States, 90706
Actively Recruiting
3
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States, 92845
Actively Recruiting
4
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
5
Collaborative Neuroscience Research, LLC
Torrance, California, United States, 90502
Actively Recruiting
6
Sunwise Clinical Research
Walnut Creek, California, United States, 94596
Actively Recruiting
7
Institute of Living
Hartford, Connecticut, United States, 06106
Actively Recruiting
8
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
9
Magno Medical Research Group
Cooper City, Florida, United States, 33024
Actively Recruiting
10
Innovative Clinical Research
Lauderhill, Florida, United States, 33319
Actively Recruiting
11
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, United States, 32751
Actively Recruiting
12
Wellness Research Center
Miami, Florida, United States, 33135
Actively Recruiting
13
Vital Medical Research
Miami, Florida, United States, 33174
Actively Recruiting
14
CLA Research
Naples, Florida, United States, 34116
Actively Recruiting
15
Apg Research, Llc
Orlando, Florida, United States, 32803
Actively Recruiting
16
PsychMe
Tampa, Florida, United States, 33614
Not Yet Recruiting
17
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
18
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
19
Re:Cognition Health - Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
20
CBH Health
Gaithersburg, Maryland, United States, 20877
Not Yet Recruiting
21
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
22
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
23
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
24
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Actively Recruiting
25
Adams Clinical Harlem
New York, New York, United States, 10029
Actively Recruiting
26
Insight Clinical Trials
Independence, Ohio, United States, 44131
Actively Recruiting
27
University of Oregon
Eugene, Oregon, United States, 97403
Actively Recruiting
28
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
29
Adams Clinical Dallas
DeSoto, Texas, United States, 75115
Actively Recruiting
30
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
31
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
32
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires, Argentina, 1058
Not Yet Recruiting
33
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, Argentina, 1133
Not Yet Recruiting
34
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires, Argentina, 1405
Actively Recruiting
35
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1056ABI
Not Yet Recruiting
36
CEN Centro Especializado en Neurociencias
Córdoba, Argentina, 5000
Not Yet Recruiting
37
Sanatorio Morra S.A.
Córdoba, Argentina, 5000
Not Yet Recruiting
38
Instituto Kremer
Córdoba, Argentina, X5004AOA
Not Yet Recruiting
39
Centro Médico Luquez
Córdoba, Argentina, X5006CBI
Not Yet Recruiting
40
INSA Instituto de Neurociencia San Agustin
La Plata, Argentina, 1900
Not Yet Recruiting
41
Global Psy Asociación Civil
La Plata, Argentina, 1904
Not Yet Recruiting
42
Resolution Psychopharmacology Research Institute
Mendoza, Argentina, 5502
Not Yet Recruiting
43
Centro de Investigación y Asistencia en Psiquiatría (CIAP)
Rosario, Argentina, 2000
Not Yet Recruiting
44
Fundacion Estudios Clinicos
Rosario, Argentina, 2000
Not Yet Recruiting
45
Hospital das Clínicas da UFMG
Belo Horizonte, Brazil, 30130-100
Not Yet Recruiting
46
Chronos Pesquisa Clínica
Brasília, Brazil, 72145-450
Not Yet Recruiting
47
Instituto de Pesquisa clinica de Campinas
Campinas, Brazil, 13060-080
Not Yet Recruiting
48
Trial Tech
Curitiba, Brazil, 80240-280
Not Yet Recruiting
49
Clinilive
Maringá, Brazil, 87013-250
Not Yet Recruiting
50
Instituto Atena de Pesquisa Clinica
Natal, Brazil, 59020-500
Not Yet Recruiting
51
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Not Yet Recruiting
52
Instituto Apice
Salvador, Brazil, 40170-180
Not Yet Recruiting
53
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Not Yet Recruiting
54
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, Brazil, 04020-060
Not Yet Recruiting
55
PSEG Centro de Pesquisa Clínica
São Paulo, Brazil, 04038-002
Not Yet Recruiting
56
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Not Yet Recruiting
57
The Fourth People's Hospital of Chengdu
Chengdu, China, 610036
Not Yet Recruiting
58
The Seventh People's Hospital of Hangzhou
Hangzhou, China, 310000
Not Yet Recruiting
59
Suzhou Guangji Hospital
Suzhou, China, 215003
Not Yet Recruiting
60
Tianjin Anding Hospital
Tianjin, China, 300022
Not Yet Recruiting
61
Wuhu Hospital of Beijing Anding hospital
Wuhu, China, 242407
Not Yet Recruiting
62
Xi An Mental Health Center
Xi'an, China, 710061
Not Yet Recruiting
63
Zhumadian Psychiatric Hospital
Zhumadian, China, 463000
Not Yet Recruiting
64
Galaxy Superspeciality Hospital
Aurangabad, India, 431001
Not Yet Recruiting
65
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, India, 462024
Not Yet Recruiting
66
Rajiv Gandhi Government General Hospital
Chennai, India, 600003
Not Yet Recruiting
67
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, India, 248008
Not Yet Recruiting
68
Dharwad Institute Of Mental Health And Neurosciences
Dharwad, India, 580008
Not Yet Recruiting
69
Calida Rehab - Karjat
Karjat, India, 410201
Not Yet Recruiting
70
Shree Mahalaxmi DIATONE Institute
Kolhāpur, India, 416001
Not Yet Recruiting
71
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, India, 226010
Not Yet Recruiting
72
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, India, 226020
Not Yet Recruiting
73
D.Y. Patil Hospital
Navi Mumbai, India, 400706
Not Yet Recruiting
74
Medipoint Hospitals Pvt. Ltd.
Pune, India, 411007
Not Yet Recruiting
75
Lifepoint Multispeciality Hospital
Pune, India, 411057
Actively Recruiting
76
Sowmanasya Hospital and Institute of Psychiatry
Tiruchirappalli, India, 620002
Not Yet Recruiting
77
Uematsu Mental Clinic
Chikugo, Japan, 833-0041
Not Yet Recruiting
78
Horikoshi Mental Somatic Clinic
Fukushima, Japan, 960-8053
Not Yet Recruiting
79
Seinan Hospital
Hachinohe, Japan, 039-1104
Not Yet Recruiting
80
Fujimidai Hospital
Hiratsuka, Japan, 259-1205
Not Yet Recruiting
81
Rainbow and Sea Hospital
Karatsu, Japan, 847-0031
Not Yet Recruiting
82
National Center of Neurology and Psychiatry
Kodaira, Japan, 187-8551
Not Yet Recruiting
83
Yuge Hospital
Kumamoto, Japan, 861-8002
Not Yet Recruiting
84
Hirota Clinic
Kurume, Japan, 830-0033
Not Yet Recruiting
85
Asuka Hospital
Machida, Japan, 194-0005
Not Yet Recruiting
86
Arata Clinic
Nagasaki, Japan, 852-8137
Not Yet Recruiting
87
Yutaka Clinic
Sagamihara, Japan, 252-0303
Not Yet Recruiting
88
Sho Midori Hospital
Saitama, Japan, 336-0022
Not Yet Recruiting
89
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, Japan, 162-0843
Not Yet Recruiting
90
Okehazama Hospital
Toyoake, Japan, 470-1168
Not Yet Recruiting
91
Yamagata Sakuracho Hospital
Yamagata, Japan, 990-0045
Not Yet Recruiting
92
Shioiri Mental Clinic
Yokosuka, Japan, 238-0042
Not Yet Recruiting
93
Changhua Christian Hospital
Changhua, Taiwan, 50006
Not Yet Recruiting
94
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Not Yet Recruiting
95
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Not Yet Recruiting
96
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Not Yet Recruiting
97
National Taiwan University Hospital
Taipei, Taiwan, 10002
Not Yet Recruiting
98
Taipei City Hospital - Songde Branch
Taipei, Taiwan, 110204
Not Yet Recruiting
99
Taipei Medical University Hospital
Taipei, Taiwan, 110
Not Yet Recruiting
100
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Not Yet Recruiting
101
Tri-Service General Hospital
Taipei, Taiwan, 114
Not Yet Recruiting
102
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Not Yet 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
2
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