A Study of Brenipatide in Adult Participants With Major Depressive Disorder

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

  • Depressive Disorder, Major

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

Accellacare - Moorpark
Moorpark, California 93021
Contact:
747-998-0394

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

Yale University School of Medicine
New Haven, Connecticut 06519
Contact:
203-932-5711

Encore Medical Research
Hollywood, Florida 33024
Contact:
954-400-1725

K2 Medical Research - Maitland
Maitland, Florida 32751

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

Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
Contact:
305-330-9977

CLA Research
Naples, Florida 34116
Contact:
239-837-8818

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

Charter Research - Orlando
Orlando, Florida 32803

K2 Medical Research - Tampa
Tampa, Florida 33634
Contact:
813-800-5252

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

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

Cedar Valley Medical Specialists
Waterloo, Iowa 50701
Contact:
319-888-8270

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

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

K2 Medical Research - Foxborough
Foxborough, Massachusetts 02035
Contact:
401-435-8950

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

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Contact:
248-312-0025

Arch Clinical Trials
St Louis, Missouri 63141
Contact:
314-282-3521

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

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

Summit Headlands
Portland, Oregon 97210
Contact:
503-314-3900

Suburban Research Associates
Media, Pennsylvania 19063

Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104

Adams Clinical Dallas
DeSoto, Texas 75115

Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104
Contact:
682-394-3500

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

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

Re:Cognition Health
Fairfax, Virginia 22031

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

SCB Research Center
Bayamón, Puerto Rico 00961
Contact:
(787) 798-4592

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