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Purpose

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Meet the diagnostic criteria for major depressive disorder - Are on a stable standard of care medication for major depressive disorder - 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 blinded study intervention, as directed - maintain electronic and paper study diaries, as applicable, and - complete the required questionnaires

Exclusion Criteria

  • Have a lifetime history or current diagnosis of the following: - schizophrenia or other psychotic disorder - bipolar disorder - borderline personality disorder, or - any eating disorder. - Have type 1 diabetes mellitus, or a history of - ketoacidosis, or - hyperosmolar state or coma. - Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening - Are actively suicidal or deemed a significant risk for suicide - Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brenipatide Dose 1 		Brenipatide administered subcutaneously (SC) + standard of care (SoC).
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Experimental
Brenipatide Dose 2 		Brenipatide administered SC + SoC
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Experimental
Brenipatide Dose 3 		Brenipatide administered SC + SoC
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Placebo Comparator
Placebo 		Placebo administered SC + SoC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

ATP Clinical Research
Orange, California 92866
Contact:
949-354-5353

Life Medical Research Group Corp
Miami Gardens, Florida 33014
Contact:
305-705-4111

Optimal Research Sites
Orange City, Florida 32763
Contact:
386-218-5911

Charter Research - Orlando
Orlando, Florida 32803

CenExel iResearch, LLC
Decatur, Georgia 30030
Contact:
404-537-1281

Indiana University Health Neuroscience Center
Indianapolis, Indiana 46202
Contact:
317-963-7300

Pharmasite Research, Inc.
Baltimore, Maryland 21208
Contact:
410-602-1440

Adams Clinical Boston
Boston, Massachusetts 02116
Contact:
617-744-8542

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

Vector Clinical Trials
Las Vegas, Nevada 89128
Contact:
702-750-0000

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

Suburban Research Associates
Media, Pennsylvania 19063

Adams Clinical Dallas
DeSoto, Texas 75115

Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104

Alpine Research Organization
Clinton, Utah 84015
Contact:
801-928-3292

Northwest Clinical Research Center
Bellevue, Washington 98007
Contact:
425-453-0404

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.