A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT07412756

Run by

Eli Lilly and Company

People needed

1000

Starts

2026-02-09

Expected to finish

2028-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ATP Clinical Research — Orange, California, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Encore Medical Research — Hollywood, Florida, United States (enrolling)
• K2 Medical Research - Maitland — Maitland, Florida, United States (enrolling)
• Life Medical Research Group Corp — Miami Gardens, Florida, United States (enrolling)
• Floridian Clinical Research, LLC — Miami Lakes, Florida, United States (enrolling)
• CLA Research — Naples, Florida, United States (enrolling)
• Optimal Research Sites — Orange City, Florida, United States (enrolling)
• Charter Research - Orlando — Orlando, Florida, United States (enrolling)
• K2 Medical Research - Tampa — Tampa, Florida, United States (enrolling)
• CenExel iResearch, LLC — Decatur, Georgia, United States (enrolling)
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States (enrolling)
• Cedar Valley Medical Specialists — Waterloo, Iowa, United States (enrolling)
• Pharmasite Research, Inc. — Baltimore, Maryland, United States (enrolling)
• Adams Clinical Boston — Boston, Massachusetts, United States (enrolling)
• K2 Medical Research - Foxborough — Foxborough, Massachusetts, United States (enrolling)
• Adams Clinical Watertown — Watertown, Massachusetts, United States (enrolling)
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (enrolling)
• Arch Clinical Trials — St Louis, Missouri, United States (enrolling)
• Vector Clinical Trials — Las Vegas, Nevada, United States (enrolling)
• Adams Clinical Harlem — New York, New York, United States (enrolling)
• Summit Headlands — Portland, Oregon, United States (enrolling)
• Suburban Research Associates — Media, Pennsylvania, United States (enrolling)
• Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States (enrolling)
• Accellacare - Moorpark — Moorpark, California, United States (enrolling)

Full record on ClinicalTrials.gov

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