Home › Schizophrenia › NCT07410507
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)
Who can join
Ages 18 to 55 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Brenipatide (drug)
- Placebo (drug)
Sponsor: Eli Lilly and Company · Participants: 450 · Started: Feb 10, 2026
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07410507
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.