A Study of Brenipatide in Adult Participants With Schizophrenia
RENEW-Scz-1
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)
2 other identifiers
interventional
450
7 countries
102
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Feb 2026
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2026
CompletedStudy Start
First participant enrolled
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
May 22, 2026
May 1, 2026
1.7 years
February 6, 2026
May 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)
Baseline, Week 52
Secondary Outcomes (10)
Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36
Baseline, Week 36
Time to Relapse
Randomization up to Week 52
Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)
Baseline, Week 52
Change from Baseline in Patient Global Impression - Severity
Baseline, Week 52
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Baseline, Week 52
- +5 more secondary outcomes
Study Arms (2)
Brenipatide
EXPERIMENTALBrenipatide administered subcutaneously (SC) + SoC.
Placebo
PLACEBO COMPARATORPlacebo administered SC + SoC.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
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
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
PsychMe
Tampa, Florida, 33614, 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 13, 2026
Study Start
February 10, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.