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RECRUITING
NCT07410507
PHASE2

A Study of Brenipatide in Adult Participants With Schizophrenia

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2026-02-10

Completion Date

2027-11

Last Updated

2026-03-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Brenipatide

Administered SC

DRUG

Placebo

Administered SC

Locations (101)

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California, United States

Collaborative Neuroscience Research, LLC

Garden Grove, California, United States

Stanford University School of Medicine

Stanford, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Institute of Living

Hartford, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Magno Medical Research Group

Cooper City, Florida, United States

Innovative Clinical Research

Lauderhill, Florida, United States

Accel Research Sites - Maitland Clinical Research Unit

Maitland, Florida, United States

Wellness Research Center

Miami, Florida, United States

Vital Medical Research

Miami, Florida, United States

CLA Research

Naples, Florida, United States

Apg Research, Llc

Orlando, Florida, United States

PsychMe

Tampa, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Re:Cognition Health - Chicago

Chicago, Illinois, United States

CBH Health

Gaithersburg, Maryland, United States

McLean Hospital

Belmont, Massachusetts, United States

Adams Clinical Watertown

Watertown, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Arch Clinical Trials

St Louis, Missouri, United States

Adams Clinical Harlem

New York, New York, United States

Insight Clinical Trials

Independence, Ohio, United States

University of Oregon

Eugene, Oregon, United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Adams Clinical Dallas

DeSoto, Texas, United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Centro Neurobiológico y de Estrés Traumático (CENydET)

Buenos Aires, Argentina

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

Buenos Aires, Argentina

Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

CEN Centro Especializado en Neurociencias

Córdoba, Argentina

Sanatorio Morra S.A.

Córdoba, Argentina

Instituto Kremer

Córdoba, Argentina

Centro Médico Luquez

Córdoba, Argentina

INSA Instituto de Neurociencia San Agustin

La Plata, Argentina

Global Psy Asociación Civil

La Plata, Argentina

Resolution Psychopharmacology Research Institute

Mendoza, Argentina

Centro de Investigación y Asistencia en Psiquiatría (CIAP)

Rosario, Argentina

Fundacion Estudios Clinicos

Rosario, Argentina

Hospital das Clínicas da UFMG

Belo Horizonte, Brazil

Chronos Pesquisa Clínica

Brasília, Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, Brazil

Trial Tech

Curitiba, Brazil

Clinilive

Maringá, Brazil

Instituto Atena de Pesquisa Clinica

Natal, Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, Brazil

Instituto Apice

Salvador, Brazil

CPQuali Pesquisa Clínica

São Paulo, Brazil

Clinica Viver - Centro de Desospitalizacao Humana

São Paulo, Brazil

PSEG Centro de Pesquisa Clínica

São Paulo, Brazil

The Second Xiangya Hospital of Central South University

Changsha, China

The Fourth People's Hospital of Chengdu

Chengdu, China

The Seventh People's Hospital of Hangzhou

Hangzhou, China

Suzhou Guangji Hospital

Suzhou, China

Tianjin Anding Hospital

Tianjin, China

Wuhu Hospital of Beijing Anding hospital

Wuhu, China

Xi An Mental Health Center

Xi'an, China

Zhumadian Psychiatric Hospital

Zhumadian, China

Galaxy Superspeciality Hospital

Aurangabad, India

All India Institute of Medical Sciences (AIIMS) - Bhopal

Bhopal, India

Rajiv Gandhi Government General Hospital

Chennai, India

Graphic Era Institute of Medical Sciences and Hospital

Dehradun, India

Dharwad Institute Of Mental Health And Neurosciences

Dharwad, India

Shree Mahalaxmi DIATONE Institute

Kolhāpur, India

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, India

Career Institute of Medical Sciences and Hospital - Lucknow

Lucknow, India

D.Y. Patil Hospital

Navi Mumbai, India

Medipoint Hospitals Pvt. Ltd.

Pune, India

Lifepoint Multispeciality Hospital

Pune, India

Sowmanasya Hospital and Institute of Psychiatry

Tiruchirappalli, India

Uematsu Mental Clinic

Chikugo, Japan

Horikoshi Mental Somatic Clinic

Fukushima, Japan

Seinan Hospital

Hachinohe, Japan

Fujimidai Hospital

Hiratsuka, Japan

Rainbow and Sea Hospital

Karatsu, Japan

National Center of Neurology and Psychiatry

Kodaira, Japan

Yuge Hospital

Kumamoto, Japan

Hirota Clinic

Kurume, Japan

Asuka Hospital

Machida, Japan

Arata Clinic

Nagasaki, Japan

Yutaka Clinic

Sagamihara, Japan

Sho Midori Hospital

Saitama, Japan

Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

Tokyo, Japan

Okehazama Hospital

Toyoake, Japan

Yamagata Sakuracho Hospital

Yamagata, Japan

Shioiri Mental Clinic

Yokosuka, Japan

Changhua Christian Hospital

Changhua, Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei City Hospital - Songde Branch

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan