Brenipatide for Schizophrenia

(RENEW-Scz-1 Trial)

Not yet recruiting at 100 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Must be taking: Standard care
Prior Safety DataThis treatment has passed at least one previous human 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?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

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

I have been diagnosed with schizophrenia.
I have someone reliable to support me during the study.
I can self-inject the medication and follow the storage/use instructions.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive brenipatide or placebo administered subcutaneously along with standard of care for schizophrenia

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

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

Group I: BrenipatideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University