Tests brenipatide added to usual care for schizophrenia
Tests brenipatide with usual care against placebo in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Adult Participants With Schizophrenia
Key facts
- Where
- Bhopal, Chhatrapati Sambhajinagar, Dharwad, Karjat, Kolhāpur, Lucknow, Navi Mumbai, Pune, and Tiruchirappalli, IndiaSee the 11 sites
- Phase
- Phase 2
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT07410507, who can take part
Where in India
- All India Institute of Medical Sciences (AIIMS) - BhopalBhopal, IndiaTaking people
- Galaxy Superspeciality HospitalChhatrapati Sambhajinagar, IndiaTaking people
- Dharwad Institute Of Mental Health And NeurosciencesDharwad, IndiaTaking people
- Calida Rehab - KarjatKarjat, IndiaTaking people
- Shree Mahalaxmi DIATONE InstituteKolhāpur, IndiaTaking people
- Career Institute of Medical Sciences and Hospital - LucknowLucknow, IndiaTaking people
- Dr Ram Manohar Lohia Institute of Medical SciencesLucknow, IndiaTaking people
- D.Y. Patil HospitalNavi Mumbai, IndiaTaking people
- Lifepoint Multispeciality HospitalPune, IndiaTaking people
- Medipoint Hospitals Pvt. Ltd.Pune, IndiaTaking people
- Sowmanasya Hospital and Institute of PsychiatryTiruchirappalli, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07410507
- Record updated
- 7 October 2026
- Original description
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
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.
Inclusion: 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: 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.