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RecruitingPhase 3

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

Eli Lilly and Company · NCT07775300

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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
29
Study start
August 14, 2026
Record last updated
October 7, 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 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.

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 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

Recruiting US locations

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, AL 35294

    Site contact: 205-934-2484

  • NoesisPharma, LLC

    Phoenix, AZ 85028

    Site contact: John Prater

  • Irvine Clinical Research

    Irvine, CA 92614

    Site contact: 949-753-1663

  • Oakland Clinical

    Oakland, CA 94609

    Site contact: T. Richard Parenteau

  • Concierge Clinical Trials

    Valley Village, CA 91607

    Site contact: Neal Cutler

  • JEM Research Institute

    Atlantis, FL 33462

    Site contact: 561-968-2933

  • Bradenton Research Center, Inc.

    Bradenton, FL 34205

    Site contact: 941-708-0005

  • Key Clinical Research

    Bradenton, FL 34207

    Site contact: 941-538-5825

  • NextPhase Research Florida - Hollywood

    Hollywood, FL 33024

    Site contact: Peter Ventre

  • Quantix Research - Miami - Southwest 72nd Street

    Miami, FL 33173

    Site contact: Sergio Jaramillo

  • Diverse Clinical Research

    Miami, FL 33175

    Site contact: Georgette DeJesus

  • CLA Research

    Naples, FL 34116

    Site contact: 239-837-8818

  • Health Synergy Clinical Research

    West Palm Beach, FL 33407

    Site contact: 786-863-3325

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, GA 30328

    Site contact: Vasundhara Cheekati

  • Charter Research - Chicago

    Chicago, IL 60618

    Site contact: Derrick Farmer

  • Pharmasite Research, Inc.

    Baltimore, MD 21208

    Site contact: 410-602-1440

  • Adams Clinical Boston

    Boston, MA 02116

    Site contact: Darin Dougherty

  • Adams Clinical Watertown

    Watertown, MA 02472

    Site contact: 617-744-8542

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, MI 48098

    Site contact: 248-312-0025

  • Be Well Clinical Studies - Omaha

    Omaha, NE 68144

    Site contact: 402-261-7093

  • Adams Clinical Bronx

    The Bronx, NY 10461

    Site contact: Shama Farooq

  • Adams Clinical Philadelphia

    Philadelphia, PA 19104

    Site contact: Cassie Blanchard

  • 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

  • Gadolin Research

    Beaumont, TX 77702

    Site contact: 409-331-6040

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Benji Kurian

  • Olympus Clinical Research

    Katy, TX 77450

    Site contact: 346-397-4457

  • Boeson Research - Provo

    Provo, UT 84604

    Site contact: 385-392-2200

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: 425-453-0404

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
All mental health studies in Alabama →
A Study of Brenipatide (LY3537031) in Adult Participants With… (NCT07775300) | Bored Studies