A Study of Brenipatide in Adult Participants With Schizophrenia

Last updated: May 13, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Tourette's Syndrome

Psychosis

Mood Disorders

Treatment

Placebo

Brenipatide

Clinical Study ID

NCT07410507
27366
J2S-MC-GZMK
  • Ages 18-55
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 onerelapse 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 studyand attend required study visits, and are willing and able to follow studyprocedures as required, such as

  • self-inject study intervention store and use the provided study intervention asdirected,

  • maintain electronic or paper study diaries, as applicable, and

  • complete the required questionnaires

Exclusion

Exclusion Criteria:

  • Have lifetime history of bipolar disorder, borderline personality disorder, or anyeating disorder

  • Evidence of moderate or severe substance or alcohol use disorder within 180 days ofscreening

  • 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 investigationalproduct or any other type of medical research judged not to be scientifically ormedically compatible with this study

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 10, 2026
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Centro Neurobiológico y de Estrés Traumático (CENydET)

    Buenos Aires, 1058
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)

    Buenos Aires, 1133
    Argentina

    Site Not Available

  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

    Buenos Aires, 1405
    Argentina

    Site Not Available

  • Centro Neurobiológico y de Estrés Traumático (CENydET)

    Buenos Aires 3435910, 1058
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires 3435910, C1056ABI
    Argentina

    Site Not Available

  • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)

    Buenos Aires 3435910, 1133
    Argentina

    Site Not Available

  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

    Buenos Aires 3435910, 1405
    Argentina

    Site Not Available

  • CEN Centro Especializado en Neurociencias

    Córdoba, 5000
    Argentina

    Site Not Available

  • Centro Médico Luquez

    Córdoba, X5006CBI
    Argentina

    Site Not Available

  • Instituto Kremer

    Córdoba, X5004AOA
    Argentina

    Site Not Available

  • Sanatorio Morra S.A.

    Córdoba, 5000
    Argentina

    Site Not Available

  • CEN Centro Especializado en Neurociencias

    Córdoba 3860259, 5000
    Argentina

    Site Not Available

  • Centro Médico Luquez

    Córdoba 3860259, X5006CBI
    Argentina

    Site Not Available

  • Instituto Kremer

    Córdoba 3860259, X5004AOA
    Argentina

    Site Not Available

  • Sanatorio Morra S.A.

    Córdoba 3860259, 5000
    Argentina

    Site Not Available

  • Global Psy Asociación Civil

    La Plata, 1904
    Argentina

    Site Not Available

  • INSA Instituto de Neurociencia San Agustin

    La Plata, 1900
    Argentina

    Site Not Available

  • Global Psy Asociación Civil

    La Plata 3432043, 1904
    Argentina

    Site Not Available

  • INSA Instituto de Neurociencia San Agustin

    La Plata 3432043, 1900
    Argentina

    Site Not Available

  • Resolution Psychopharmacology Research Institute

    Mendoza, 5502
    Argentina

    Site Not Available

  • Resolution Psychopharmacology Research Institute

    Mendoza 3844421, 5502
    Argentina

    Site Not Available

  • Centro de Investigación y Asistencia en Psiquiatría (CIAP)

    Rosario, 2000
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario, 2000
    Argentina

    Site Not Available

  • Centro de Investigación y Asistencia en Psiquiatría (CIAP)

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • Hospital das Clínicas da UFMG

    Belo Horizonte, 30130-100
    Brazil

    Site Not Available

  • Hospital das Clínicas da UFMG

    Belo Horizonte 3470127, 30130-100
    Brazil

    Site Not Available

  • Chronos Pesquisa Clínica

    Brasília, 72145-450
    Brazil

    Site Not Available

  • Chronos Pesquisa Clínica

    Brasília 3469058, 72145-450
    Brazil

    Site Not Available

  • Instituto de Pesquisa clinica de Campinas

    Campinas, 13060-080
    Brazil

    Site Not Available

  • Instituto de Pesquisa clinica de Campinas

    Campinas 3467865, 13060-080
    Brazil

    Site Not Available

  • Trial Tech

    Curitiba, 80240-280
    Brazil

    Site Not Available

  • Trial Tech

    Curitiba 3464975, 80240-280
    Brazil

    Site Not Available

  • Clinilive

    Maringá, 87013-250
    Brazil

    Site Not Available

  • Clinilive

    Maringá 3457671, 87013-250
    Brazil

    Site Not Available

  • Instituto Atena de Pesquisa Clinica

    Natal, 59020-500
    Brazil

    Site Not Available

  • Instituto Atena de Pesquisa Clinica

    Natal 3394023, 59020-500
    Brazil

    Site Not Available

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060
    Brazil

    Site Not Available

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro 3451190, 22270-060
    Brazil

    Site Not Available

  • Instituto Apice

    Salvador, 40170-180
    Brazil

    Site Not Available

  • Instituto Apice

    Salvador 3450554, 40170-180
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Clinica Viver - Centro de Desospitalizacao Humana

    São Paulo, 04020-060
    Brazil

    Site Not Available

  • PSEG Centro de Pesquisa Clínica

    São Paulo, 04038-002
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo 3448439, 01228-000
    Brazil

    Site Not Available

  • Clinica Viver - Centro de Desospitalizacao Humana

    São Paulo 3448439, 04020-060
    Brazil

    Site Not Available

  • PSEG Centro de Pesquisa Clínica

    São Paulo 3448439, 04038-002
    Brazil

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, 410011
    China

    Site Not Available

  • The Fourth People's Hospital of Chengdu

    Chengdu, 610036
    China

    Site Not Available

  • The Fourth People's Hospital of Chengdu

    Chengdu 1815286, 610036
    China

    Site Not Available

  • The Seventh People's Hospital of Hangzhou

    Hangzhou, 310000
    China

    Site Not Available

  • The Seventh People's Hospital of Hangzhou

    Hangzhou 1808926, 310000
    China

    Site Not Available

  • Suzhou Guangji Hospital

    Suzhou, 215003
    China

    Site Not Available

  • Suzhou Guangji Hospital

    Suzhou 1886760, 215003
    China

    Site Not Available

  • Tianjin Anding Hospital

    Tianjin, 300022
    China

    Site Not Available

  • Tianjin Anding Hospital

    Tianjin 1792947, 300022
    China

    Site Not Available

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu, 242407
    China

    Site Not Available

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu 1791236, 242407
    China

    Site Not Available

  • Xi An Mental Health Center

    Xi'an, 710061
    China

    Site Not Available

  • Xi An Mental Health Center

    Xi'an 1790630, 710061
    China

    Site Not Available

  • Zhumadian Psychiatric Hospital

    Zhumadian, 463000
    China

    Site Not Available

  • Zhumadian Psychiatric Hospital

    Zhumadian 1783873, 463000
    China

    Site Not Available

  • Galaxy Superspeciality Hospital

    Aurangabad, 431001
    India

    Site Not Available

  • Galaxy Superspeciality Hospital

    Aurangabad 1278149, 431001
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS) - Bhopal

    Bhopal, 462024
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS) - Bhopal

    Bhopal 1275841, 462024
    India

    Site Not Available

  • Rajiv Gandhi Government General Hospital

    Chennai, 600003
    India

    Site Not Available

  • Rajiv Gandhi Government General Hospital

    Chennai 1264527, 600003
    India

    Site Not Available

  • Graphic Era Institute of Medical Sciences and Hospital

    Dehradun, 248008
    India

    Site Not Available

  • Graphic Era Institute of Medical Sciences and Hospital

    Dehradun 1273313, 248008
    India

    Site Not Available

  • Dharwad Institute Of Mental Health And Neurosciences

    Dharwad, 580008
    India

    Site Not Available

  • Dharwad Institute Of Mental Health And Neurosciences

    Dharwad 1272818, 580008
    India

    Site Not Available

  • Calida Rehab - Karjat

    Karjat, 410201
    India

    Site Not Available

  • Shree Mahalaxmi DIATONE Institute

    Kolhāpur, 416001
    India

    Site Not Available

  • Shree Mahalaxmi DIATONE Institute

    Kolhāpur 1266285, 416001
    India

    Site Not Available

  • Career Institute of Medical Sciences and Hospital - Lucknow

    Lucknow, 226020
    India

    Site Not Available

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, 226010
    India

    Site Not Available

  • Career Institute of Medical Sciences and Hospital - Lucknow

    Lucknow 1264733, 226020
    India

    Site Not Available

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    Lucknow 1264733, 226010
    India

    Site Not Available

  • D.Y. Patil Hospital

    Navi Mumbai, 400706
    India

    Site Not Available

  • D.Y. Patil Hospital

    Navi Mumbai 6619347, 400706
    India

    Site Not Available

  • Lifepoint Multispeciality Hospital

    Pune, 411057
    India

    Site Not Available

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007
    India

    Site Not Available

  • Lifepoint Multispeciality Hospital

    Pune 1259229, 411057
    India

    Site Not Available

  • Medipoint Hospitals Pvt. Ltd.

    Pune 1259229, 411007
    India

    Site Not Available

  • Sowmanasya Hospital and Institute of Psychiatry

    Tiruchirappalli, 620002
    India

    Site Not Available

  • Sowmanasya Hospital and Institute of Psychiatry

    Tiruchirappalli 1254388, 620002
    India

    Site Not Available

  • Uematsu Mental Clinic

    Chikugo, 833-0041
    Japan

    Site Not Available

  • Uematsu Mental Clinic

    Chikugo 11611638, 833-0041
    Japan

    Site Not Available

  • Horikoshi Mental Somatic Clinic

    Fukushima, 960-8053
    Japan

    Site Not Available

  • Horikoshi Mental Somatic Clinic

    Fukushima 2112923, 960-8053
    Japan

    Site Not Available

  • Seinan Hospital

    Hachinohe, 039-1104
    Japan

    Site Not Available

  • Seinan Hospital

    Hachinohe 2130203, 039-1104
    Japan

    Site Not Available

  • Fujimidai Hospital

    Hiratsuka, 259-1205
    Japan

    Site Not Available

  • Fujimidai Hospital

    Hiratsuka 1862462, 259-1205
    Japan

    Site Not Available

  • Rainbow and Sea Hospital

    Karatsu, 847-0031
    Japan

    Site Not Available

  • Rainbow and Sea Hospital

    Karatsu 1860063, 847-0031
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira, 187-8551
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira 11611930, 187-8551
    Japan

    Site Not Available

  • Yuge Hospital

    Kumamoto, 861-8002
    Japan

    Site Not Available

  • Yuge Hospital

    Kumamoto 1858421, 861-8002
    Japan

    Site Not Available

  • Hirota Clinic

    Kurume, 830-0033
    Japan

    Site Not Available

  • Hirota Clinic

    Kurume 1858088, 830-0033
    Japan

    Site Not Available

  • Asuka Hospital

    Machida, 194-0005
    Japan

    Site Not Available

  • Asuka Hospital

    Machida 1857871, 194-0005
    Japan

    Site Not Available

  • Arata Clinic

    Nagasaki, 852-8137
    Japan

    Site Not Available

  • Arata Clinic

    Nagasaki 1856177, 852-8137
    Japan

    Site Not Available

  • Yutaka Clinic

    Sagamihara, 252-0303
    Japan

    Site Not Available

  • Yutaka Clinic

    Sagamihara 11611609, 252-0303
    Japan

    Site Not Available

  • Sho Midori Hospital

    Saitama, 336-0022
    Japan

    Site Not Available

  • Sho Midori Hospital

    Saitama 6940394, 336-0022
    Japan

    Site Not Available

  • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

    Tokyo, 162-0843
    Japan

    Site Not Available

  • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

    Tokyo 1850147, 162-0843
    Japan

    Site Not Available

  • Okehazama Hospital

    Toyoake, 470-1168
    Japan

    Site Not Available

  • Okehazama Hospital

    Toyoake 6822210, 470-1168
    Japan

    Site Not Available

  • Yamagata Sakuracho Hospital

    Yamagata, 990-0045
    Japan

    Site Not Available

  • Yamagata Sakuracho Hospital

    Yamagata 2110556, 990-0045
    Japan

    Site Not Available

  • Shioiri Mental Clinic

    Yokosuka, 238-0042
    Japan

    Site Not Available

  • Shioiri Mental Clinic

    Yokosuka 1848313, 238-0042
    Japan

    Site Not Available

  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

    Site Not Available

  • Changhua Christian Hospital

    Changhua County, 50006
    Taiwan

    Site Not Available

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204
    Taiwan

    Site Not Available

  • Keelung Chang Gung Memorial Hospital

    Keelung 1678228, 204
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 402
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung 1668399, 402
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei City Hospital - Songde Branch

    Taipei, 110204
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei, 110
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 114
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Taipei City Hospital - Songde Branch

    Taipei 1668341, 110204
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei 1668341, 114
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Pillar Clinical Research- Little Rock

    Little Rock, Arkansas 72204
    United States

    Active - Recruiting

  • Pillar Clinical Research- Little Rock

    Little Rock 4119403, Arkansas 4099753 72204
    United States

    Site Not Available

  • Clinical Innovations, Inc. dba CITrials

    Bellflower, California 90706
    United States

    Active - Recruiting

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Active - Recruiting

  • Collaborative Neuroscience Research, LLC

    Torrance, California 90502
    United States

    Active - Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Clinical Innovations, Inc. dba CITrials

    Bellflower 5327422, California 5332921 90706
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Garden Grove 5351515, California 5332921 92845
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Torrance 5403022, California 5332921 90502
    United States

    Site Not Available

  • Sunwise Clinical Research

    Walnut Creek 5406990, California 5332921 94596
    United States

    Site Not Available

  • Institute of Living

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Institute of Living

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Site Not Available

  • Magno Medical Research Group

    Cooper City, Florida 33024
    United States

    Active - Recruiting

  • Innovative Clinical Research

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • Accel Research Sites - Maitland Clinical Research Unit

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Vital Medical Research

    Miami, Florida 33174
    United States

    Active - Recruiting

  • Wellness Research Center

    Miami, Florida 33135
    United States

    Site Not Available

  • CLA Research

    Naples, Florida 34116
    United States

    Active - Recruiting

  • Apg Research, Llc

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • PsychMe

    Tampa, Florida 33614
    United States

    Site Not Available

  • Magno Medical Research Group

    Cooper City 4151824, Florida 4155751 33024
    United States

    Site Not Available

  • Innovative Clinical Research

    Lauderhill 4161625, Florida 4155751 33319
    United States

    Site Not Available

  • Accel Research Sites - Maitland Clinical Research Unit

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Vital Medical Research

    Miami 4164138, Florida 4155751 33174
    United States

    Site Not Available

  • Wellness Research Center

    Miami 4164138, Florida 4155751 33135
    United States

    Site Not Available

  • CLA Research

    Naples 4165565, Florida 4155751 34116
    United States

    Site Not Available

  • Apg Research, Llc

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • PsychMe

    Tampa 4174757, Florida 4155751 33614
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Augusta University

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • Re:Cognition Health - Chicago

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Re:Cognition Health - Chicago

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • CBH Health

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Site Not Available

  • McLean Hospital

    Belmont, Massachusetts 02478
    United States

    Active - Recruiting

  • Adams Clinical Watertown

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • McLean Hospital

    Belmont 4930282, Massachusetts 6254926 02478
    United States

    Site Not Available

  • Adams Clinical Watertown

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • Arch Clinical Trials

    St Louis, Missouri 63141
    United States

    Active - Recruiting

  • Arch Clinical Trials

    St Louis 4407066, Missouri 4398678 63141
    United States

    Site Not Available

  • Adams Clinical Harlem

    New York, New York 10029
    United States

    Active - Recruiting

  • Adams Clinical Harlem

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Insight Clinical Trials

    Independence, Ohio 44131
    United States

    Active - Recruiting

  • Insight Clinical Trials

    Independence 5158404, Ohio 5165418 44131
    United States

    Site Not Available

  • University of Oregon

    Eugene, Oregon 97403
    United States

    Active - Recruiting

  • University of Oregon

    Eugene 5725846, Oregon 5744337 97403
    United States

    Site Not Available

  • Adams Clinical Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Adams Clinical Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Adams Clinical Dallas

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Adams Clinical Dallas

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Re:Cognition Health - Fort Worth

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

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