A Study of Brenipatide in Participants With Major Depressive Disorder

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

330 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study evaluates the safety and efficacy of brenipatide (LY3537031) as an add on therapy in participants with major depression who still have symptoms while taking a stable dose of standard of care anti-depressant medicine.

The study will last approximately 5 months.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Have a diagnosis of Major Depressive Disorder (MDD) and are in a current major depressive episode, without psychotic features
• Are on a stable antidepressant monotherapy regimen for the current major depressive episode
• Are a partial responder to the current antidepressant monotherapy regimen
• 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
• other personality disorders that would interfere with compliance with the study protocol
• neurocognitive disorders or intellectual disability, or
• any eating disorder
• Have type 1 diabetes mellitus, or a history of

• ketoacidosis, or
• hyperosmolar state or coma
• Have had a history of any substance or alcohol use disorder of any severity within 180 days before Visit 1
• 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 Visit 1

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (75)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

75 locations

Study team and timeline

Lead sponsor

Eli Lilly and Company

Study start

2026-11 Estimated

Primary completion

2028-05 Estimated

Study completion

2028-07 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts