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NCT07410507PHASE2Recruiting

A Study of Brenipatide in Adult Participants With Schizophrenia

Eli Lilly and Company

Start Date

2/10/2026

Completion Date

11/1/2027

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

Age Range: 18 years to 55 years

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 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 store and use the provided study intervention as directed, * maintain electronic or paper study diaries, as applicable, and * complete the required questionnaires Exclusion Criteria: * 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

Interventions

DRUG

Brenipatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Schizophrenia

Locations

Pillar Clinical Research- Little Rock

Little Rock, Arkansas 72204

United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California 90706

United States

Collaborative Neuroscience Research, LLC

Garden Grove, California 92845

United States

Catalina Research Institute, LLC

Montclair, California 91763

United States

Stanford University School of Medicine

Stanford, California 94305

United States

Collaborative Neuroscience Research, LLC

Torrance, California 90502

United States

Sunwise Clinical Research

Walnut Creek, California 94596

United States

Institute of Living

Hartford, Connecticut 06106

United States

Yale University School of Medicine

New Haven, Connecticut 06511

United States

Magno Medical Research Group

Cooper City, Florida 33024

United States

Innovative Clinical Research

Lauderhill, Florida 33319

United States

Accel Research Sites - Maitland Clinical Research Unit

Maitland, Florida 32751

United States

Wellness Research Center

Miami, Florida 33135

United States

Vital Medical Research

Miami, Florida 33174

United States

CLA Research

Naples, Florida 34116

United States

Apg Research, Llc

Orlando, Florida 32803

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Augusta University

Augusta, Georgia 30912

United States

Re:Cognition Health - Chicago

Chicago, Illinois 60611

United States

CBH Health

Gaithersburg, Maryland 20877

United States

McLean Hospital

Belmont, Massachusetts 02478

United States

Adams Clinical Watertown

Watertown, Massachusetts 02472

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Arch Clinical Trials

St Louis, Missouri 63141

United States

Adams Clinical Harlem

New York, New York 10029

United States

Insight Clinical Trials

Independence, Ohio 44131

United States

University of Oregon

Eugene, Oregon 97403

United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania 19104

United States

Adams Clinical Dallas

DeSoto, Texas 75115

United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas 76104

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Centro Neurobiológico y de Estrés Traumático (CENydET)

Buenos Aires, 1058

Argentina

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

Buenos Aires, 1133

Argentina

Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

Buenos Aires, 1405

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI

Argentina

CEN Centro Especializado en Neurociencias

Córdoba, 5000

Argentina

Sanatorio Morra S.A.

Córdoba, 5000

Argentina

Instituto Kremer

Córdoba, X5004AOA

Argentina

Centro Médico Luquez

Córdoba, X5006CBI

Argentina

INSA Instituto de Neurociencia San Agustin

La Plata, 1900

Argentina

Global Psy Asociación Civil

La Plata, 1904

Argentina

Resolution Psychopharmacology Research Institute

Mendoza, 5502

Argentina

Centro de Investigación y Asistencia en Psiquiatría (CIAP)

Rosario, 2000

Argentina

Fundacion Estudios Clinicos

Rosario, 2000

Argentina

Hospital das Clínicas da UFMG

Belo Horizonte, 30130-100

Brazil

Chronos Pesquisa Clínica

Brasília, 72145-450

Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080

Brazil

Trial Tech

Curitiba, 80240-280

Brazil

Clinilive

Maringá, 87013-250

Brazil

Instituto Atena de Pesquisa Clinica

Natal, 59020-500

Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060

Brazil

Instituto Apice

Salvador, 40170-180

Brazil

CPQuali Pesquisa Clínica

São Paulo, 01228-000

Brazil

Clinica Viver - Centro de Desospitalizacao Humana

São Paulo, 04020-060

Brazil

PSEG Centro de Pesquisa Clínica

São Paulo, 04038-002

Brazil

The Second Xiangya Hospital of Central South University

Changsha, 410011

China

The Fourth People's Hospital of Chengdu

Chengdu, 610036

China

The Seventh People's Hospital of Hangzhou

Hangzhou, 310000

China

Suzhou Guangji Hospital

Suzhou, 215003

China

Tianjin Anding Hospital

Tianjin, 300022

China

Wuhu Hospital of Beijing Anding hospital

Wuhu, 242407

China

Xi An Mental Health Center

Xi'an, 710061

China

Zhumadian Psychiatric Hospital

Zhumadian, 463000

China

Galaxy Superspeciality Hospital

Aurangabad, 431001

India

All India Institute of Medical Sciences (AIIMS) - Bhopal

Bhopal, 462024

India

Rajiv Gandhi Government General Hospital

Chennai, 600003

India

Graphic Era Institute of Medical Sciences and Hospital

Dehradun, 248008

India

Dharwad Institute Of Mental Health And Neurosciences

Dharwad, 580008

India

Calida Rehab - Karjat

Karjat, 410201

India

Shree Mahalaxmi DIATONE Institute

Kolhāpur, 416001

India

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, 226010

India

Career Institute of Medical Sciences and Hospital - Lucknow

Lucknow, 226020

India

D.Y. Patil Hospital

Navi Mumbai, 400706

India

Medipoint Hospitals Pvt. Ltd.

Pune, 411007

India

Lifepoint Multispeciality Hospital

Pune, 411057

India

Sowmanasya Hospital and Institute of Psychiatry

Tiruchirappalli, 620002

India

Uematsu Mental Clinic

Chikugo, 833-0041

Japan

Horikoshi Mental Somatic Clinic

Fukushima, 960-8053

Japan

Seinan Hospital

Hachinohe, 039-1104

Japan

Fujimidai Hospital

Hiratsuka, 259-1205

Japan

Rainbow and Sea Hospital

Karatsu, 847-0031

Japan

National Center of Neurology and Psychiatry

Kodaira, 187-8551

Japan

Yuge Hospital

Kumamoto, 861-8002

Japan

Hirota Clinic

Kurume, 830-0033

Japan

Asuka Hospital

Machida, 194-0005

Japan

Arata Clinic

Nagasaki, 852-8137

Japan

Yutaka Clinic

Sagamihara, 252-0303

Japan

Sho Midori Hospital

Saitama, 336-0022

Japan

Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

Tokyo, 162-0843

Japan

Okehazama Hospital

Toyoake, 470-1168

Japan

Yamagata Sakuracho Hospital

Yamagata, 990-0045

Japan

Shioiri Mental Clinic

Yokosuka, 238-0042

Japan

Changhua Christian Hospital

Changhua, 50006

Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, 204

Taiwan

Chung Shan Medical University Hospital

Taichung, 402

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei City Hospital - Songde Branch

Taipei, 110204

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Tri-Service General Hospital

Taipei, 114

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan