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Phase 3Recruiting

A Study of Brenipatide 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 (26)

  • ATP Clinical Research

    Orange, California

    Call 949-354-5353

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  • Accellacare - Moorpark

    Moorpark, California

    Call 747-998-0394

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  • Yale University School of Medicine

    New Haven, Connecticut

    Call 203-932-5711

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  • Floridian Clinical Research, LLC

    Miami Lakes, Florida

    Call 305-330-9977

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  • Encore Medical Research

    Hollywood, Florida

    Call 954-400-1725

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Show all 26 locations

  • Optimal Research Sites

    Orange City, Florida

    Call 386-218-5911

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  • Life Medical Research Group Corp

    Miami Gardens, Florida

    Call 305-705-4111

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  • K2 Medical Research - Tampa

    Tampa, Florida

    Call 813-800-5252

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  • CLA Research

    Naples, Florida

    Call 239-837-8818

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  • CenExel iResearch, LLC

    Decatur, Georgia

    Call 404-537-1281

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  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana

    Call 317-963-7300

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  • Cedar Valley Medical Specialists

    Waterloo, Iowa

    Call 319-888-8270

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  • Pharmasite Research, Inc.

    Baltimore, Maryland

    Call 410-602-1440

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  • Adams Clinical Boston

    Boston, Massachusetts

    Call 617-744-8542

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  • Adams Clinical Watertown

    Watertown, Massachusetts

    Call 617-744-8542

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  • K2 Medical Research - Foxborough

    Foxborough, Massachusetts

    Call 401-435-8950

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  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan

    Call 248-312-0025

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  • Arch Clinical Trials

    St Louis, Missouri

    Call 314-282-3521

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  • Vector Clinical Trials

    Las Vegas, Nevada

    Call 702-750-0000

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  • Adams Clinical Harlem

    New York, New York

    Call 917-423-67697

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  • Summit Headlands

    Portland, Oregon

    Call 503-314-3900

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  • Circle Clinical Research

    Sioux Falls, South Dakota

    Call 605-215-1159

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  • Consano Clinical Research, LLC

    Shavano Park, Texas

    Call 210-545-4900

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  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas

    Call 682-394-3500

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  • Alpine Research Organization

    Clinton, Utah

    Call 801-928-3292

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  • Northwest Clinical Research Center

    Bellevue, Washington

    Call 425-453-0404

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Who can participate

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

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.