NCT07410507RecruitingPhase 2
A Study of Brenipatide in Adult Participants With Schizophrenia
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)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 10 Feb 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Schizophrenia
- NCT number
- NCT07410507
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 450
- From 10 Feb 2026 to the primary completion date, Nov 2027
- 101 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Are actively suicidal or deemed to be a significant risk for suicide
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (101)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Neurobiológico y de Estrés Traumático (CENydET) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Instituto Nacional de Psicopatología (INAPsi)- FunDaMos Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Fundacion CENIT para la Investigacion en Neurociencias Coordinator of this site? Confirm its status | Caba | Argentina | Not yet recruiting |
| Sanatorio Morra S.A. Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Centro Médico Luquez Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Instituto Kremer Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| CEN Centro Especializado en Neurociencias Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| INSA Instituto de Neurociencia San Agustin Coordinator of this site? Confirm its status | La Plata | Argentina | Recruiting |
| Global Psy Asociación Civil Coordinator of this site? Confirm its status | La Plata | Argentina | Recruiting |
| Resolution Psychopharmacology Research Institute Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Centro de Investigacion y Asistencia en Psiquiatria (CIAP) Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Fundacion Estudios Clinicos Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Hospital das Clinicas da UFMG Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Chronos Pesquisa Clínica Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Trial Tech Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Clinilive Coordinator of this site? Confirm its status | Maringá | Brazil | Recruiting |
| Instituto Atena de Pesquisa Clínica Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Ruschel Medicina e Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Instituto Apice Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| PSEG Centro de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Clinica Viver - Centro de Desospitalizacao Humana Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The Fourth People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Seventh People's Hospital of Hangzhou Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Suzhou Guangji Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Tianjin Anding Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Wuhu Hospital of Beijing Anding hospital Coordinator of this site? Confirm its status | Wuhu | China | Recruiting |
| Xi'an Mental Health Center Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Zhumadian Psychiatric Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Recruiting |
| All India Institute of Medical Sciences (AIIMS) - Bhopal Coordinator of this site? Confirm its status | Bhopal | India | Recruiting |
| Galaxy Superspeciality Hospital Coordinator of this site? Confirm its status | Chhatrapati Sambhajinagar | India | Recruiting |
| Dharwad Institute Of Mental Health And Neurosciences Coordinator of this site? Confirm its status | Dharwad | India | Recruiting |
| Calida Rehab - Karjat Coordinator of this site? Confirm its status | Karjat | India | Recruiting |
| Shree Mahalaxmi DIATONE Institute Coordinator of this site? Confirm its status | Kolhāpur | India | Recruiting |
| Career Institute of Medical Sciences and Hospital - Lucknow Coordinator of this site? Confirm its status | Lucknow | India | Recruiting |
| Dr Ram Manohar Lohia Institute of Medical Sciences Coordinator of this site? Confirm its status | Lucknow | India | Recruiting |
| D.Y. Patil Hospital Coordinator of this site? Confirm its status | Navi Mumbai | India | Recruiting |
| Lifepoint Multispeciality Hospital Coordinator of this site? Confirm its status | Pune | India | Recruiting |
| Medipoint Hospitals Pvt. Ltd. Coordinator of this site? Confirm its status | Pune | India | Recruiting |
| Sowmanasya Hospital and Institute of Psychiatry Coordinator of this site? Confirm its status | Tiruchirappalli | India | Recruiting |
| Uematsu Mental Clinic Coordinator of this site? Confirm its status | Chikugo | Japan | Recruiting |
| Horikoshi Mental Somatic Clinic Coordinator of this site? Confirm its status | Fukushima | Japan | Recruiting |
| Seinan Hospital Coordinator of this site? Confirm its status | Hachinohe | Japan | Not yet recruiting |
| Fujimidai Hospital Coordinator of this site? Confirm its status | Hiratsuka | Japan | Recruiting |
| Rainbow and Sea Hospital Coordinator of this site? Confirm its status | Karatsu | Japan | Recruiting |
| National Center of Neurology and Psychiatry Coordinator of this site? Confirm its status | Kodaira | Japan | Recruiting |
| Yuge Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Hirota Clinic Coordinator of this site? Confirm its status | Kurume | Japan | Recruiting |
| Asuka Hospital Coordinator of this site? Confirm its status | Machida | Japan | Recruiting |
| Arata Clinic Coordinator of this site? Confirm its status | Nagasaki | Japan | Recruiting |
| Yutaka Clinic Coordinator of this site? Confirm its status | Sagamihara | Japan | Recruiting |
| Sho Midori Hospital Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Okehazama Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Recruiting |
| Yamagata Sakuracho Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Recruiting |
| Shioiri Mental Clinic Coordinator of this site? Confirm its status | Yokosuka | Japan | Recruiting |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Recruiting |
| Keelung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Keelung | Taiwan | Recruiting |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei City Hospital - Songde Branch Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Atlanta Center for Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Clinical Innovations, Inc. dba CITrials Coordinator of this site? Confirm its status | Bellflower | United States | Recruiting |
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
| Re:Cognition Health - Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Magno Medical Research Group Coordinator of this site? Confirm its status | Cooper City | United States | Recruiting |
| Adams Clinical Dallas Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| University of Oregon Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Re:Cognition Health - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| CBH Health Coordinator of this site? Confirm its status | Gaithersburg | United States | Recruiting |
| Collaborative NeuroScience Research , LLC Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| Institute of Living Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| NextPhase Research Florida - Hollywood Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Insight Clinical Trials Coordinator of this site? Confirm its status | Independence | United States | Recruiting |
| Innovative Clinical Research Coordinator of this site? Confirm its status | Lauderhill | United States | Recruiting |
| Pillar Clinical Research - Little Rock Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Accel Research Sites - Maitland Clinical Research Unit Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Wellness Research Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Vital Medical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Catalina Research Institute, LLC Coordinator of this site? Confirm its status | Montclair | United States | Recruiting |
| CLA Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Adams Clinical Harlem Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| APG Research, LLC Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Adams Clinical Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Arch Clinical Trials Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Collaborative Neuroscience Research LLC Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| Sunwise Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Adams Clinical Watertown Coordinator of this site? Confirm its status | Watertown | United States | Recruiting |
| University of Massachusetts Chan Medical School Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.