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A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

Sponsored by Eli Lilly and Company

About this study

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.

Where this study is enrolling (25)

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama

    Call 205-934-2484

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  • NoesisPharma, LLC

    Phoenix, Arizona

    Call 602.795.1834

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  • Irvine Clinical Research

    Irvine, California

    Call 9497531663

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  • Healthy Brain Clinic

    Long Beach, California

    Call 562-606-5999

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  • Health Synergy Clinical Research

    West Palm Beach, Florida

    Call 786-863-3325

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Show all 25 locations
  • Bradenton Research Center, Inc.

    Bradenton, Florida

    Call 9417080005

    This research site can be reached directly by phone. Call to ask about this study.

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  • CLA Research

    Naples, Florida

    Call 2398378818

    This research site can be reached directly by phone. Call to ask about this study.

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  • De La Cruz Research Center, LLC

    Miami, Florida

    Call 786-977-6155

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  • JEM Research Institute

    Atlantis, Florida

    Call 5619682933

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  • Key Clinical Research

    Bradenton, Florida

    Call 9415385825

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  • Miami Jewish health

    Miami, Florida

    Call 3055148503

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  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia

    I'm interested
  • Charter Research - Chicago

    Chicago, Illinois

    I'm interested
  • Pharmasite Research, Inc.

    Baltimore, Maryland

    Call 410 602-1440

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  • Adams Clinical Watertown

    Watertown, Massachusetts

    Call 6177448542

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  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan

    Call 248-312-0025

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  • Be Well Clinical Studies - Omaha

    Omaha, Nebraska

    Call 402-261-7093

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  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania

    Call 610 820 0342

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  • Adams Clinical Philadelphia

    Philadelphia, Pennsylvania

    I'm interested
  • The University of Texas Rio Grande Valley

    Harlingen, Texas

    Call 956 296 5527

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  • Olympus Clinical Research

    Katy, Texas

    Call 346-397-4457

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  • Gadolin Research

    Beaumont, Texas

    Call 409-331-6040

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  • Consano Clinical Research, LLC

    Shavano Park, Texas

    Call 210-545-4900

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  • Boeson Research - Provo

    Provo, Utah

    Call 385-392-2200

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  • Northwest Clinical Research Center

    Bellevue, Washington

    Call 4254530404

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Who can participate

Inclusion criteria

  • ✓Meet the diagnostic criteria for major depressive disorder
  • ✓Are on 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 spectrum 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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.