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Taking people in ArgentinaPhase 2

Tests brenipatide added to usual care for schizophrenia

Tests brenipatide with usual care against placebo in adults with schizophrenia.

Key facts

Who runs it
Eli Lilly and Company
Where
Buenos Aires, Caba, Córdoba, La Plata, Mendoza, and Rosario, ArgentinaSee the 13 sitesAlso in 6 other countries, 88 sites
Trial code
Registry title
A Study of Brenipatide in Adult Participants With Schizophrenia
Status
Recruiting
Phase
Phase 2
People taking part
450 people, planned
Started
10 Feb 2026
Expected to end
Nov 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Brenipatide
  • Placebo
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 55 with schizophrenia who already take a stable standard medication. Brenipatide or placebo is added to their usual treatment.

Age
18 to 55 years
Sex
All sexes can join.
Disease stage
Schizophrenia. If the illness has lasted more than 6 years, at least one relapse in the last 3 years is needed.
Earlier treatment
A stable standard medication regimen for schizophrenia.

Main reasons for not taking part

  • Lifetime history of bipolar disorder, borderline personality disorder or any eating disorder
  • Moderate or severe substance or alcohol use disorder within 180 days of screening
  • Type 1 diabetes, or a history of ketoacidosis or hyperosmolar state or coma
  • Actively suicidal or a significant suicide risk
  • Currently in another clinical study or medical research that does not fit with this study

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

Where in Argentina

Also in 6 other countries, 88 sites

  • Centro Neurobiológico y de Estrés Traumático (CENydET)Buenos Aires, ArgentinaContact: Enrique Kuper (principal investigator)Taking people
  • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)Buenos Aires, ArgentinaContact: Ricardo Corral (principal investigator)Taking people
  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMosBuenos Aires, ArgentinaContact: Luis Mosca (principal investigator)Taking people
  • Fundacion CENIT para la Investigacion en NeurocienciasCaba, ArgentinaContact: Griselda Russo (principal investigator)Not yet recruiting
  • CEN Centro Especializado en NeurocienciasCórdoba, ArgentinaContact: Hernan Ruggeri (principal investigator)Taking people
  • Centro Médico LuquezCórdoba, ArgentinaContact: Juan Luquez (principal investigator)Taking people
  • Instituto KremerCórdoba, ArgentinaContact: TAMARA YERCOVICH (principal investigator)Taking people
  • Sanatorio Morra S.A.Córdoba, ArgentinaContact: Carlos Morra (principal investigator)Taking people
  • Global Psy Asociación CivilLa Plata, ArgentinaContact: Hernan Alessandria (principal investigator)Taking people
  • INSA Instituto de Neurociencia San AgustinLa Plata, ArgentinaContact: Hector Lamaison (principal investigator)Taking people
  • Resolution Psychopharmacology Research InstituteMendoza, ArgentinaContact: Eugenio Velasco (principal investigator)Taking people
  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)Rosario, ArgentinaContact: Christian Lupo (principal investigator)Taking people
  • Fundacion Estudios ClinicosRosario, ArgentinaContact: Javier Travella (principal investigator)Taking people

About the trial

What the trial wants to find out

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 full original descriptionShow less

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.

The 2 groups in the trial

  • BrenipatideTreatment being tested

    Brenipatide administered subcutaneously (SC) + SoC.

  • PlaceboPlacebo, for comparison

    Placebo administered SC + SoC.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests brenipatide added to usual care for schizophreniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07410507, who can take part
Record updated
7 October 2026