A Study of Brenipatide in Adult Participants With Schizophrenia

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

  • Schizophrenia

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

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
Contact:
508-856-3881

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