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New drug aims to improve schizophrenia treatment and reduce relapse

NCT ID NCT07410507

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 8 times

Summary

This study tests whether adding brenipatide to standard schizophrenia medication is safe and effective. About 450 adults with schizophrenia will receive either brenipatide or a placebo for up to 12 months. The study looks at weight changes, cognitive function, and time to relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    103 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accel Research Sites - Maitland Clinical Research Unit

    RECRUITING

    Maitland, Florida, 32751, United States

  • Adams Clinical Dallas

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Adams Clinical Harlem

    RECRUITING

    New York, New York, 10029, United States

  • Adams Clinical Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Adams Clinical Watertown

    RECRUITING

    Watertown, Massachusetts, 02472, United States

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

    RECRUITING

    Bhopal, 462024, India

  • Apg Research, Llc

    RECRUITING

    Orlando, Florida, 32803, United States

  • Arata Clinic

    RECRUITING

    Nagasaki, 852-8137, Japan

  • Arch Clinical Trials

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Asuka Hospital

    RECRUITING

    Machida, 194-0005, Japan

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • CBH Health

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • CEN Centro Especializado en Neurociencias

    RECRUITING

    Córdoba, 5000, Argentina

  • CLA Research

    RECRUITING

    Naples, Florida, 34116, United States

  • CPQuali Pesquisa Clínica

    RECRUITING

    São Paulo, 01228-000, Brazil

  • Calida Rehab - Karjat

    NOT_YET_RECRUITING

    Karjat, 410201, India

  • Career Institute of Medical Sciences and Hospital - Lucknow

    RECRUITING

    Lucknow, 226020, India

  • Catalina Research Institute, LLC

    NOT_YET_RECRUITING

    Montclair, California, 91763, United States

  • Centro Médico Luquez

    RECRUITING

    Córdoba, X5006CBI, Argentina

  • Centro Neurobiológico y de Estrés Traumático (CENydET)

    RECRUITING

    Buenos Aires, 1058, Argentina

  • Centro de Investigación y Asistencia en Psiquiatría (CIAP)

    RECRUITING

    Rosario, 2000, Argentina

  • Chang Gung Medical Foundation-Linkou Branch

    RECRUITING

    Taoyuan, 333, Taiwan

  • Changhua Christian Hospital

    RECRUITING

    Changhua, 50006, Taiwan

  • Chronos Pesquisa Clínica

    RECRUITING

    Brasília, 72145-450, Brazil

  • Chung Shan Medical University Hospital

    RECRUITING

    Taichung, 402, Taiwan

  • Clinica Viver - Centro de Desospitalizacao Humana

    RECRUITING

    São Paulo, 04020-060, Brazil

  • Clinical Innovations, Inc. dba CITrials

    RECRUITING

    Bellflower, California, 90706, United States

  • Clinilive

    RECRUITING

    Maringá, 87013-250, Brazil

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Garden Grove, California, 92845, United States

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Torrance, California, 90502, United States

  • D.Y. Patil Hospital

    RECRUITING

    Navi Mumbai, 400706, India

  • Dharwad Institute Of Mental Health And Neurosciences

    RECRUITING

    Dharwad, 580008, India

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    RECRUITING

    Lucknow, 226010, India

  • Fujimidai Hospital

    RECRUITING

    Hiratsuka, 259-1205, Japan

  • Fundacion Estudios Clinicos

    RECRUITING

    Rosario, 2000, Argentina

  • Fundación Cenit Para La Investigación En Neurociencias

    NOT_YET_RECRUITING

    CABA, 1125, Argentina

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

    RECRUITING

    Buenos Aires, 1133, Argentina

  • Galaxy Superspeciality Hospital

    RECRUITING

    Aurangabad, 431001, India

  • Global Psy Asociación Civil

    RECRUITING

    La Plata, 1904, Argentina

  • Graphic Era Institute of Medical Sciences and Hospital

    NOT_YET_RECRUITING

    Dehradun, 248008, India

  • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

    RECRUITING

    Tokyo, 162-0843, Japan

  • Hirota Clinic

    RECRUITING

    Kurume, 830-0033, Japan

  • Horikoshi Mental Somatic Clinic

    RECRUITING

    Fukushima, 960-8053, Japan

  • Hospital das Clínicas da UFMG

    NOT_YET_RECRUITING

    Belo Horizonte, 30130-100, Brazil

  • INSA Instituto de Neurociencia San Agustin

    RECRUITING

    La Plata, 1900, Argentina

  • Innovative Clinical Research

    RECRUITING

    Lauderhill, Florida, 33319, United States

  • Insight Clinical Trials

    RECRUITING

    Independence, Ohio, 44131, United States

  • Institute of Living

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Instituto Apice

    NOT_YET_RECRUITING

    Salvador, 40170-180, Brazil

  • Instituto Atena de Pesquisa Clinica

    RECRUITING

    Natal, 59020-500, Brazil

  • Instituto Kremer

    RECRUITING

    Córdoba, X5004AOA, Argentina

  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

    RECRUITING

    Buenos Aires, 1405, Argentina

  • Instituto de Pesquisa clinica de Campinas

    RECRUITING

    Campinas, 13060-080, Brazil

  • Keelung Chang Gung Memorial Hospital

    RECRUITING

    Keelung, 204, Taiwan

  • Lifepoint Multispeciality Hospital

    RECRUITING

    Pune, 411057, India

  • Magno Medical Research Group

    RECRUITING

    Cooper City, Florida, 33024, United States

  • McLean Hospital

    RECRUITING

    Belmont, Massachusetts, 02478, United States

  • Medipoint Hospitals Pvt. Ltd.

    RECRUITING

    Pune, 411007, India

  • National Center of Neurology and Psychiatry

    RECRUITING

    Kodaira, 187-8551, Japan

  • National Cheng Kung University Hospital

    NOT_YET_RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • NextPhase Research Florida - Hollywood

    NOT_YET_RECRUITING

    Hollywood, Florida, 33024, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Okehazama Hospital

    RECRUITING

    Toyoake, 470-1168, Japan

  • PSEG Centro de Pesquisa Clínica

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Pillar Clinical Research- Little Rock

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Rainbow and Sea Hospital

    RECRUITING

    Karatsu, 847-0031, Japan

  • Rajiv Gandhi Government General Hospital

    SUSPENDED

    Chennai, 600003, India

  • Re:Cognition Health - Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Re:Cognition Health - Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Resolution Psychopharmacology Research Institute

    RECRUITING

    Mendoza, 5502, Argentina

  • Ruschel Medicina e Pesquisa Clínica

    NOT_YET_RECRUITING

    Rio de Janeiro, 22270-060, Brazil

  • Sanatorio Morra S.A.

    NOT_YET_RECRUITING

    Córdoba, 5000, Argentina

  • Seinan Hospital

    NOT_YET_RECRUITING

    Hachinohe, 039-1104, Japan

  • Shioiri Mental Clinic

    RECRUITING

    Yokosuka, 238-0042, Japan

  • Sho Midori Hospital

    RECRUITING

    Saitama, 336-0022, Japan

  • Shree Mahalaxmi DIATONE Institute

    RECRUITING

    Kolhāpur, 416001, India

  • Sowmanasya Hospital and Institute of Psychiatry

    RECRUITING

    Tiruchirappalli, 620002, India

  • Stanford University School of Medicine

    RECRUITING

    Stanford, California, 94305, United States

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Suzhou Guangji Hospital

    RECRUITING

    Suzhou, 215003, China

  • Taipei City Hospital - Songde Branch

    NOT_YET_RECRUITING

    Taipei, 110204, Taiwan

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • The Fourth People's Hospital of Chengdu

    RECRUITING

    Chengdu, 610036, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, 410011, China

  • The Seventh People's Hospital of Hangzhou

    RECRUITING

    Hangzhou, 310000, China

  • Tianjin Anding Hospital

    RECRUITING

    Tianjin, 300022, China

  • Tri-Service General Hospital

    NOT_YET_RECRUITING

    Taipei, 114, Taiwan

  • Trial Tech

    RECRUITING

    Curitiba, 80240-280, Brazil

  • Uematsu Mental Clinic

    RECRUITING

    Chikugo, 833-0041, Japan

  • University of Massachusetts Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Oregon

    RECRUITING

    Eugene, Oregon, 97403, United States

  • Vital Medical Research

    RECRUITING

    Miami, Florida, 33174, United States

  • Wellness Research Center

    RECRUITING

    Miami, Florida, 33135, United States

  • Wuhu Hospital of Beijing Anding hospital

    RECRUITING

    Wuhu, 242407, China

  • Xi An Mental Health Center

    RECRUITING

    Xi'an, 710061, China

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Yamagata Sakuracho Hospital

    RECRUITING

    Yamagata, 990-0045, Japan

  • Yuge Hospital

    RECRUITING

    Kumamoto, 861-8002, Japan

  • Yutaka Clinic

    RECRUITING

    Sagamihara, 252-0303, Japan

  • Zhumadian Psychiatric Hospital

    RECRUITING

    Zhumadian, 463000, China

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