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RecruitingPhase 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Eli Lilly and Company · NCT07412756

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1000
US sites recruiting
32
Study start
February 9, 2026
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

Being studied: Brenipatide; Placebo

Conditions: Depressive Disorder, Major

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Accellacare - Moorpark

    Moorpark, CA 93021

    Site contact: 747-998-0394

  • ATP Clinical Research

    Orange, CA 92866

    Site contact: 9493545353

  • Yale University School of Medicine

    New Haven, CT 06519

    Site contact: 2039325711

  • Encore Medical Research

    Hollywood, FL 33024

    Site contact: 954-400-1725

  • K2 Medical Research - Maitland

    Maitland, FL 32751

    Site contact: Sejal Patel

  • Life Medical Research Group Corp

    Miami Gardens, FL 33014

    Site contact: 305-705-4111

  • Floridian Clinical Research, LLC

    Miami Lakes, FL 33016-1518

    Site contact: 305-330-9977

  • CLA Research

    Naples, FL 34116

    Site contact: 2398378818

  • Optimal Research Sites

    Orange City, FL 32763

    Site contact: 3862185911

  • Charter Research - Orlando

    Orlando, FL 32803

    Site contact: Jorel Martinez

  • K2 Medical Research - Tampa

    Tampa, FL 33634

    Site contact: 813.800.5252

  • CenExel iResearch, LLC

    Decatur, GA 30030

    Site contact: 404-537-1281

  • Indiana University Health Neuroscience Center

    Indianapolis, IN 46202

    Site contact: 3179637300

  • Cedar Valley Medical Specialists

    Waterloo, IA 50701

    Site contact: 319-888-8270

  • Pharmasite Research, Inc.

    Baltimore, MD 21208

    Site contact: 410 602-1440

  • Adams Clinical Boston

    Boston, MA 02116

    Site contact: (617) 744-8542

  • K2 Medical Research - Foxborough

    Foxborough, MA 02035

    Site contact: 401-435-8950

  • Adams Clinical Watertown

    Watertown, MA 02472

    Site contact: 6177448542

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, MI 48098

    Site contact: 248-312-0025

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: 314-282-3521

  • Vector Clinical Trials

    Las Vegas, NV 89128

    Site contact: 7027500000

  • Adams Clinical Harlem

    New York, NY 10029

    Site contact: 917-423-67697

  • Summit Headlands

    Portland, OR 97210

    Site contact: 5033143900

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, PA 19104

    Site contact: yvette sheline

  • Suburban Research Associates

    West Chester, PA 19380

    Site contact: Omer Abdullah

  • Circle Clinical Research

    Sioux Falls, SD 57104

    Site contact: 6052151159

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Benji Kurian

  • Re:Cognition Health - Fort Worth

    Fort Worth, TX 76104

    Site contact: Syed Quadri

  • Consano Clinical Research, LLC

    Shavano Park, TX 78231

    Site contact: 210-545-4900

  • Alpine Research Organization

    Clinton, UT 84015

    Site contact: 801-928-3292

  • Re:Cognition Health

    Fairfax, VA 22031

    Site contact: Scott Williams

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: 4254530404

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Brenipatide in Adult Participants With Major Depressive… (NCT07412756) | Bored Studies