Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
NCT07410507

A Study of Brenipatide in Adult Participants With Schizophrenia

Led by Eli Lilly and Company · Updated on 2026-05-14

450

Participants Needed

102

Research Sites

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

CONDITIONS

Official Title

A Study of Brenipatide in Adult Participants With Schizophrenia

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria of schizophrenia
  • Are on a stable standard of care medication regimen for schizophrenia
  • If the duration of illness is >6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
  • Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
  • 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, maintain electronic or paper study diaries, and complete the required questionnaires
Not Eligible

You will not qualify if you...

  • Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
  • Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
  • Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
  • Are actively suicidal or deemed to be a significant risk for suicide
  • Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Not Yet 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

Not Yet 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

Not Yet 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

Not Yet 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

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

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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