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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brenipatide 		Brenipatide administered subcutaneously (SC) + SoC.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Placebo Comparator
Placebo 		Placebo administered SC + SoC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204

Clinical Innovations, Inc. dba CITrials
Bellflower, California 90706
Contact:
562-249-6956

Collaborative Neuroscience Research, LLC
Garden Grove, California 92845
Contact:
714-799-7799

Stanford University School of Medicine
Stanford, California 94305
Contact:
650-723-3305

Collaborative Neuroscience Research, LLC
Torrance, California 90502
Contact:
310-523-4200

Institute of Living
Hartford, Connecticut 06106

Magno Medical Research Group
Cooper City, Florida 33024
Contact:
954-589-0658

Vital Medical Research
Miami, Florida 33174
Contact:
305-703-4414

Atlanta Center for Medical Research
Atlanta, Georgia 30331

Adams Clinical Watertown
Watertown, Massachusetts 02472
Contact:
617-744-8542

Adams Clinical Harlem
New York, New York 10029
Contact:
917-423-67697

University of Oregon
Eugene, Oregon 97403
Contact:
310-844-6458

Adams Clinical Philadelphia
Philadelphia, Pennsylvania 19104

Adams Clinical Dallas
DeSoto, Texas 75115

Northwest Clinical Research Center
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.