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SchizophreniaPhase 2RENEW-Scz-1NCT07410507

A Study of Brenipatide in Adult Participants With Schizophrenia

A Phase 2 study testing Brenipatide in people with Schizophrenia, run by Eli Lilly and Company at 101 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
Brenipatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
101 sitesin 7 countries
Study dates
10 Feb 2026to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

101 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

101 sites in 7 countries

United States32 sites, 32 recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

    Elyssa Barron

    Recruiting

  • Augusta University

    Augusta, Georgia, 30912

    Joseph McEvoy

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    425-453-0404

    Arun Arora

    Recruiting

  • Clinical Innovations, Inc. dba CITrials

    Bellflower, California, 90706

    562-249-6956

    Gerald Maguire

    Recruiting

  • McLean Hospital

    Belmont, Massachusetts, 02478

    Virginie-Anne Chouinard

    Recruiting

  • Re:Cognition Health - Chicago

    Chicago, Illinois, 60611

    Abid Nazeer

    Recruiting

  • Magno Medical Research Group

    Cooper City, Florida, 33024

    954-589-0658

    Richard Douyon

    Recruiting

  • Adams Clinical Dallas

    DeSoto, Texas, 75115

    Benji Kurian

    Recruiting

  • University of Oregon

    Eugene, Oregon, 97403

    310-844-6458

    Fred Sabb

    Recruiting

  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas, 76104

    Syed Quadri

    Recruiting

  • CBH Health

    Gaithersburg, Maryland, 20877

    301-251-4702

    Elia Acevedo Diaz

    Recruiting

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California, 92845

    714-799-7799

    David Walling

    Recruiting

  • Institute of Living

    Hartford, Connecticut, 06106

    Benjamin Anderson

    Recruiting

  • NextPhase Research Florida - Hollywood

    Hollywood, Florida, 33024

    Peter Ventre

    Recruiting

  • Insight Clinical Trials

    Independence, Ohio, 44131

    216-526-1843

    Mark Stillman

    Recruiting

  • Innovative Clinical Research

    Lauderhill, Florida, 33319

    786-570-1971

    Rishi Kakar

    Recruiting

  • Pillar Clinical Research- Little Rock

    Little Rock, Arkansas, 72204

    Leslie Smith

    Recruiting

  • Accel Research Sites - Maitland Clinical Research Unit

    Maitland, Florida, 32751

    386-785-2400

    Andrea Marraffino

    Recruiting

  • Wellness Research Center

    Miami, Florida, 33135

    305-300-2623

    Emilio Mantero-Atienza

    Recruiting

  • Vital Medical Research

    Miami, Florida, 33174

    305-703-4414

    Linda Collado

    Recruiting

  • Catalina Research Institute, LLC

    Montclair, California, 91763

    Stephen Volk

    Recruiting

  • CLA Research

    Naples, Florida, 34116

    239-837-8818

    Evelia Iglesias

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

    Youngsun Cho

    Recruiting

  • Adams Clinical Harlem

    New York, New York, 10029

    917-423-67697

    Rachel Noone

    Recruiting

  • Apg Research, Llc

    Orlando, Florida, 32803

    MORTEZA NADJAFI

    Recruiting

  • Adams Clinical Philadelphia

    Philadelphia, Pennsylvania, 19104

    Cassie Blanchard

    Recruiting

  • Arch Clinical Trials

    St Louis, Missouri, 63141

    314-282-3521

    Junaid Syed

    Recruiting

  • Stanford University School of Medicine

    Stanford, California, 94305

    650-723-3305

    Jacob Ballon

    Recruiting

  • Collaborative Neuroscience Research, LLC

    Torrance, California, 90502

    310-523-4200

    Lara Shirikjian

    Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

    925-298-5147

    Ira Glick

    Recruiting

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472

    617-744-8542

    Dyanna Domilici

    Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

    508-856-3881

    Xiaoduo Fan

    Recruiting

Other trials in United States

Japan16 sites, 16 recruiting

  • Uematsu Mental Clinic

    Chikugo, 833-0041

    81120023812

    Ken Uematsu

    Recruiting

  • Horikoshi Mental Somatic Clinic

    Fukushima, 960-8053

    81120023812

    Sho Horikoshi

    Recruiting

  • Seinan Hospital

    Hachinohe, 039-1104

    81120023812

    Takashi Fukasawa

    Not yet recruiting

  • Fujimidai Hospital

    Hiratsuka, 259-1205

    81120023812

    Takafumi Yahoko

    Recruiting

  • Rainbow and Sea Hospital

    Karatsu, 847-0031

    81120023812

    Taro Shindo

    Recruiting

  • National Center of Neurology and Psychiatry

    Kodaira, 187-8551

    81120023812

    Tomiki Sumiyoshi

    Recruiting

  • Yuge Hospital

    Kumamoto, 861-8002

    81120023812

    Masahiro Shono

    Recruiting

  • Hirota Clinic

    Kurume, 830-0033

    81120023812

    Susumu Hirota

    Recruiting

  • Asuka Hospital

    Machida, 194-0005

    81120023812

    yoshie tamura

    Recruiting

  • Arata Clinic

    Nagasaki, 852-8137

    81120023812

    Takatoshi Mori

    Recruiting

  • Yutaka Clinic

    Sagamihara, 252-0303

    81120023812

    Hideo Muraoka

    Recruiting

  • Sho Midori Hospital

    Saitama, 336-0022

    81120023812

    Yohei Kita

    Recruiting

  • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

    Tokyo, 162-0843

    81120023812

    Seiji Hongo

    Recruiting

  • Okehazama Hospital

    Toyoake, 470-1168

    81120023812

    kiyoshi Fujita

    Recruiting

  • Yamagata Sakuracho Hospital

    Yamagata, 990-0045

    81120023812

    Nobuhiro Yokokawa

    Recruiting

  • Shioiri Mental Clinic

    Yokosuka, 238-0042

    81120023812

    Kenichi Goto

    Recruiting

Other trials in Japan

Argentina13 sites, 13 recruiting

  • Centro Neurobiológico y de Estrés Traumático (CENydET)

    Buenos Aires, 1058

    +5411 4313 4916

    Enrique Kuper

    Recruiting

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

    Buenos Aires, 1133

    5491144455572

    Ricardo Corral

    Recruiting

  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

    Buenos Aires, 1405

    +5491156257810

    Luis Mosca

    Recruiting

  • Fundación Cenit Para La Investigación En Neurociencias

    CABA, 1125

    5491125891973

    Griselda Russo

    Not yet recruiting

  • CEN Centro Especializado en Neurociencias

    Córdoba, 5000

    543515339477

    Hernan Ruggeri

    Recruiting

  • Sanatorio Morra S.A.

    Córdoba, 5000

    +5493516858696

    Carlos Morra

    Recruiting

  • Instituto Kremer

    Córdoba, X5004AOA

    TAMARA YERCOVICH

    Recruiting

  • Centro Médico Luquez

    Córdoba, X5006CBI

    +5493517481586

    Juan Luquez

    Recruiting

  • INSA Instituto de Neurociencia San Agustin

    La Plata, 1900

    5402214538862

    Hector Lamaison

    Recruiting

  • Global Psy Asociación Civil

    La Plata, 1904

    Hernan Alessandria

    Recruiting

  • Resolution Psychopharmacology Research Institute

    Mendoza, 5502

    +54 9 2615861633

    Eugenio Velasco

    Recruiting

  • Centro de Investigación y Asistencia en Psiquiatría (CIAP)

    Rosario, 2000

    +5493413612594

    Christian Lupo

    Recruiting

  • Fundacion Estudios Clinicos

    Rosario, 2000

    03415290041

    Javier Travella

    Recruiting

Other trials in Argentina

Brazil11 sites, 11 recruiting

  • Hospital das Clínicas da UFMG

    Belo Horizonte, 30130-100

    31991990093

    Frederico Garcia

    Recruiting

  • Chronos Pesquisa Clínica

    Brasília, 72145-450

    +55 61 98208-4248

    Monique Scalco

    Recruiting

  • Instituto de Pesquisa clinica de Campinas

    Campinas, 13060-080

    Alexandre Comandule

    Recruiting

  • Trial Tech

    Curitiba, 80240-280

    41992061583

    Hamilton Grabowski

    Recruiting

  • Clinilive

    Maringá, 87013-250

    Antonio da Silva

    Recruiting

  • Instituto Atena de Pesquisa Clinica

    Natal, 59020-500

    +55 84 99664-5782

    Emerson Nunes

    Recruiting

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

    55 21 35979708

    Sandra Ruschel

    Recruiting

  • Instituto Apice

    Salvador, 40170-180

    Ivete Santos

    Recruiting

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

    +55 (11) 2776-6801

    Moacyr Rosa

    Recruiting

  • Clinica Viver - Centro de Desospitalizacao Humana

    São Paulo, 04020-060

    +55 11 99892-9840

    CLAUDIANE DALTIO

    Recruiting

  • PSEG Centro de Pesquisa Clínica

    São Paulo, 04038-002

    Paulo Victor Sgobbi de Souza

    Recruiting

Other trials in Brazil

India11 sites, 11 recruiting

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

    Bhopal, 462024

    Tamonud Modak

    Recruiting

  • Galaxy Superspeciality Hospital

    Chhatrapati Sambhajinagar, 431001

    Amol Deshmukh

    Recruiting

  • Dharwad Institute Of Mental Health And Neurosciences

    Dharwad, 580008

    Srinivas Kosgi

    Recruiting

  • Calida Rehab - Karjat

    Karjat, 410201

    Prashant Dasud

    Recruiting

  • Shree Mahalaxmi DIATONE Institute

    Kolhāpur, 416001

    Shreyansh Patil

    Recruiting

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, 226010

    Abdul Qadir Jilani

    Recruiting

  • Career Institute of Medical Sciences and Hospital - Lucknow

    Lucknow, 226020

    Abbas Mehdi

    Recruiting

  • D.Y. Patil Hospital

    Navi Mumbai, 400706

    +91 9021909400

    Chetan Vispute

    Recruiting

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007

    Bhalchandra Kalmegh

    Recruiting

  • Lifepoint Multispeciality Hospital

    Pune, 411057

    Nitin Dalaya

    Recruiting

  • Sowmanasya Hospital and Institute of Psychiatry

    Tiruchirappalli, 620002

    Gopalakrishnan Ganesan

    Recruiting

Other trials in India

Taiwan10 sites, 10 recruiting

  • Changhua Christian Hospital

    Changhua, 50006

    Hsu Wen-Yu

    Recruiting

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204

    Chih-Ken Chen

    Recruiting

  • Chung Shan Medical University Hospital

    Taichung, 402

    Po-Chung Ju

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    +886-6-2353535ext.5213

    Yen Kuang Yang

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Chen-Chung Liu

    Recruiting

  • Taipei City Hospital - Songde Branch

    Taipei, 110204

    Po-Yu Chen

    Not yet recruiting

  • Taipei Medical University Hospital

    Taipei, 110

    0970405254

    Kuo-Hsuan Chung

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Ya-Mei Bai

    Recruiting

  • Tri-Service General Hospital

    Taipei, 114

    Chin-Bin Yeh

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Huang-Li Lin

    Recruiting

Other trials in Taiwan

China8 sites, 8 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

    18908457721

    Xiaoping Wang

    Recruiting

  • The Fourth People's Hospital of Chengdu

    Chengdu, 610036

    13980601321

    Xiaohan Jia

    Recruiting

  • The Seventh People's Hospital of Hangzhou

    Hangzhou, 310000

    Tao Li

    Recruiting

  • Suzhou Guangji Hospital

    Suzhou, 215003

    Chuanwei Li

    Recruiting

  • Tianjin Anding Hospital

    Tianjin, 300022

    Lina Wang

    Recruiting

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu, 242407

    Changqing Hu

    Recruiting

  • Xi An Mental Health Center

    Xi'an, 710061

    Huali Lin

    Recruiting

  • Zhumadian Psychiatric Hospital

    Zhumadian, 463000

    Hua Guo

    Recruiting

Other trials in China

About this study

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)

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
Schizophrenia
Being tested
Brenipatide, Placebo
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrenipatideDrug

    Also called LY3537031

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT07410507
Study groupRoleWhat they receive
BrenipatideExperimentalBrenipatide administered subcutaneously (SC) + SoC.
Receives: Drug: Brenipatide
PlaceboPlacebo comparatorPlacebo administered SC + SoC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)

    Measured: Baseline, Week 52

Secondary outcomes (10)

  1. Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36

    Measured: Baseline, Week 36

  2. Time to Relapse

    Time to relapse defined as days from randomization to the dates on which the participant meets any relapse criteria.

    Measured: Randomization up to Week 52

  3. Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)

    Measured: Baseline, Week 52

  4. Change from Baseline in Patient Global Impression - Severity

    Measured: Baseline, Week 52

  5. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

    Measured: Baseline, Week 52

  6. Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time

    Measured: Baseline, Week 52

  7. Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score

    Measured: Baseline, Week 52

  8. Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5%

    Measured: Baseline up to 52 Weeks

  9. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Measured: Baseline up to Week 52

  10. Number of Participants with Treatment-Emergent Anti-Drug Antibodies

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start10 Feb 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07410507
Sponsor's protocol ID
27366
Other IDs
J2S-MC-GZMK
Acronym
RENEW-Scz-1
Status last verified
Oct 2026
First submitted
6 Feb 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brenipatide in people with Schizophrenia, run by Eli Lilly and Company at 101 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Japan, Argentina, Brazil, India and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07410507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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