Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT07775300

Conditions

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brenipatide

Placebo

Study Details

Brief summary:

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.

Conditions

Depressive Disorder, Major

Study ID

NCT07775300

Start date

Aug 14, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brenipatide Dose 1

Brenipatide administered subcutaneous (SC) + standard of care (SoC).

experimental: Brenipatide Dose 2

Brenipatide administered SC + SoC.

experimental: Brenipatide Dose 3

Brenipatide administered SC + SoC.

placebo comparator: Placebo

Placebo administered SC + SoC.

Interventions

Brenipatide

Administered SC.

Placebo

Administered SC.

Primary outcome measure

Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD) [ Time Frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months ]

Central Contacts and Locations

Central contacts

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

Locations

Irvine Clinical Research

Recruiting

Irvine, California, United States, 92614

Contacts

949-753-1663

Principal Investigator:

Elly Lee

Oakland Clinical

Recruiting

Oakland, California, United States, 94609

Principal Investigator:

T. Richard Parenteau

Concierge Clinical Trials

Recruiting

Valley Village, California, United States, 91607

Principal Investigator:

Neal Cutler

JEM Research Institute

Recruiting

Atlantis, Florida, United States, 33462

Contacts

561-968-2933

Principal Investigator:

Linda Pao

Bradenton Research Center, Inc.

Recruiting

Bradenton, Florida, United States, 34205

Contacts

941-708-0005

Principal Investigator:

Eric Folkens

Key Clinical Research

Recruiting

Bradenton, Florida, United States, 34207

Contacts

941-538-5825

Principal Investigator:

Nicholas Weber

NextPhase Research Florida - Hollywood

Recruiting

Hollywood, Florida, United States, 33024

Principal Investigator:

Peter Ventre

Quantix Research - Miami - Southwest 72nd Street

Recruiting

Miami, Florida, United States, 33173

Principal Investigator:

Sergio Jaramillo

Diverse Clinical Research

Recruiting

Miami, Florida, United States, 33175

Principal Investigator:

Georgette DeJesus

CLA Research

Recruiting

Naples, Florida, United States, 34116

Contacts

239-837-8818

Principal Investigator:

Evelia Iglesias

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

786-863-3325

Principal Investigator:

Mohammad Nisar

AGILE Clinical Research Trials, LLC

Recruiting

Sandy Springs, Georgia, United States, 30328

Principal Investigator:

Vasundhara Cheekati

Charter Research - Chicago

Recruiting

Chicago, Illinois, United States, 60618

Principal Investigator:

Derrick Farmer

Pharmasite Research, Inc.

Recruiting

Baltimore, Maryland, United States, 21208

Contacts

410-602-1440

Principal Investigator:

Sarah Herts

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Principal Investigator:

Darin Dougherty

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

617-744-8542

Principal Investigator:

Stephanie Ellickson

Adams Clinical Bronx

Recruiting

The Bronx, New York, United States, 10461

Principal Investigator:

Shama Farooq

Adams Clinical Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Cassie Blanchard

Penn Medicine: University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

yvette sheline

Gadolin Research

Recruiting

Beaumont, Texas, United States, 77702

Contacts

409-331-6040

Principal Investigator:

John Fowler

Adams Clinical Dallas

Recruiting

DeSoto, Texas, United States, 75115

Principal Investigator:

Benji Kurian

Olympus Clinical Research

Recruiting

Katy, Texas, United States, 77450

Contacts

346-397-4457

Principal Investigator:

Benjamin Wowo

Boeson Research - Provo

Recruiting

Provo, Utah, United States, 84604

Contacts

385-392-2200

Principal Investigator:

Jason Andersen

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

425-453-0404

Principal Investigator:

Wisam Al jumaili

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

Major Depressive Episode
Mood Disorders
Depression
Depressive Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.