NCT07410507 · Eli Lilly and Company
A Study of Brenipatide in Adult Participants With Schizophrenia
(RENEW-Scz-1)
What this study is about
The purpose of this study is to assess the effectiveness and safety of brenipatide when administered with the usual treatment (SoC) compared to placebo plus SoC for treatment of schizophrenia.
View original scientific 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. 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Little Rock, Arkansas
- Bellflower, California
- Garden Grove, California
- Montclair, California
- Stanford, California
- Torrance, California
- Walnut Creek, California
- Hartford, Connecticut
- New Haven, Connecticut
- Cooper City, Florida
- Lauderhill, Florida
- Maitland, Florida
And 19 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations