Recruiting
Phase 3

Brenipatide

Sponsor:

Eli Lilly and Company

Code:

NCT07412756

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

NCT07412756

Start date

Feb 9, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

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 subcutaneously (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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Accellacare - Moorpark

Recruiting

Moorpark, California, United States, 93021

Contacts

747-998-0394

Principal Investigator:

Arjun Reyes

ATP Clinical Research

Recruiting

Orange, California, United States, 92866

Contacts

949-354-5353

Principal Investigator:

Gustavo Alva

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

203-932-5711

Principal Investigator:

Mohini Ranganathan

Encore Medical Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

954-400-1725

Principal Investigator:

Alen Hidalgo

K2 Medical Research - Maitland

Recruiting

Maitland, Florida, United States, 32751

Principal Investigator:

Sejal Patel

Life Medical Research Group Corp

Recruiting

Miami Gardens, Florida, United States, 33014

Contacts

305-705-4111

Principal Investigator:

Rafael Conte

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016-1518

Contacts

305-330-9977

Principal Investigator:

Hortensia Valeron

CLA Research

Recruiting

Naples, Florida, United States, 34116

Contacts

239-837-8818

Principal Investigator:

Evelia Iglesias

Optimal Research Sites

Recruiting

Orange City, Florida, United States, 32763

Contacts

386-218-5911

Principal Investigator:

Antonio Cubano

Charter Research - Orlando

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

Jorel Martinez

K2 Medical Research - Tampa

Recruiting

Tampa, Florida, United States, 33634

Contacts

813-800-5252

Principal Investigator:

Kelley Wilson

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

404-537-1281

Principal Investigator:

Saundra Maass-Robinson

Indiana University Health Neuroscience Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

317-963-7300

Principal Investigator:

Stephen Strakowski

Cedar Valley Medical Specialists

Recruiting

Waterloo, Iowa, United States, 50701

Contacts

319-888-8270

Principal Investigator:

James Poock

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

Contacts

617-744-8542

Principal Investigator:

Dyanna Domilici

K2 Medical Research - Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

401-435-8950

Principal Investigator:

john stoukides

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

617-744-8542

Principal Investigator:

Stephanie Ellickson

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Recruiting

Troy, Michigan, United States, 48098

Contacts

248-312-0025

Principal Investigator:

Neil Fraser

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

314-282-3521

Principal Investigator:

Junaid Syed

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-750-0000

Principal Investigator:

Ann Childress

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

Contacts

917-423-67697

Principal Investigator:

Rachel Noone

Summit Headlands

Recruiting

Portland, Oregon, United States, 97210

Contacts

503-314-3900

Principal Investigator:

Beal Essink

Suburban Research Associates

Recruiting

Media, Pennsylvania, United States, 19063

Principal Investigator:

Kristen Dopf

Penn Medicine: University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

yvette sheline

Adams Clinical Dallas

Recruiting

DeSoto, Texas, United States, 75115

Principal Investigator:

Benji Kurian

Re:Cognition Health - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

682-394-3500

Principal Investigator:

Sondra Bell

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

210-545-4900

Principal Investigator:

Michelle Welch

Alpine Research Organization

Recruiting

Clinton, Utah, United States, 84015

Contacts

801-928-3292

Principal Investigator:

Michael Roundy

Re:Cognition Health

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Scott Williams

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

425-453-0404

Principal Investigator:

Arun Arora

Alpha Recherche Clinique - Lévis

Recruiting

Lévis, Canada, G6V 0C9

Principal Investigator:

Julie Beaudoin

Dar Clinical Research - Ottawa

Recruiting

Ottawa, Canada, K2J 3Z6

Principal Investigator:

Jabir Jassam

Alpha Recherche Clinique

Recruiting

Québec, Canada, G2J 0C4

Contacts

418-704-1112

Principal Investigator:

Raphael Poulin-Robitaille

ALPHA Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

Contacts

418-847-1112

Principal Investigator:

Jérôme Nadeau

Richmond Clinical Trials

Recruiting

Richmond, Canada, V6V 2L1

Contacts

604-373-4954

Principal Investigator:

Harris Lari

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Major Depressive Episode
  • Mood Disorders
  • Depression
  • Depressive Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-06.