Brenipatide for Schizophrenia
(RENEW-Scz-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with schizophrenia who meet the diagnostic criteria, are on a stable medication regimen, and if ill for over 6 years, have had at least one relapse in the past 3 years. Participants must have a reliable study partner and be able to self-inject the treatment, maintain diaries, and complete questionnaires.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brenipatide or placebo administered subcutaneously along with standard of care for schizophrenia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brenipatide
Trial Overview
The study tests Brenipatide's effectiveness and safety when added to standard care versus a placebo plus standard care in treating schizophrenia. It includes about 1 month of screening, up to 12 months of treatment, followed by roughly 2 months follow-up.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Brenipatide administered subcutaneously (SC) + SoC.
Placebo administered SC + SoC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
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