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Recruiting Phase 3

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

NCT07775300 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2026-08-14
Last updated
2026-10-07

Condition(s) studied

Depressive Disorder, Major

Investigational drug(s) / intervention(s)

Brenipatide →Placebo

Brenipatide: Administered SC.

Placebo: Administered SC.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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) — From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

Trial sites (170)

FacilityCityRegionStatus
University of Alabama at Birmingham - School of Medicine Birmingham Alabama Recruiting
NoesisPharma, LLC Phoenix Arizona Recruiting
Irvine Clinical Research Irvine California Recruiting
Healthy Brain Clinic Long Beach California Not Yet Recruiting
Oakland Clinical Oakland California Recruiting
Concierge Clinical Trials Valley Village California Recruiting
JEM Research Institute Atlantis Florida Recruiting
Bradenton Research Center, Inc. Bradenton Florida Recruiting
Key Clinical Research Bradenton Florida Recruiting
NextPhase Research Florida - Hollywood Hollywood Florida Recruiting
Miami Jewish health Miami Florida Not Yet Recruiting
Quantix Research - Miami - Southwest 72nd Street Miami Florida Recruiting
Diverse Clinical Research Miami Florida Recruiting
CLA Research Naples Florida Recruiting
Health Synergy Clinical Research West Palm Beach Florida Recruiting
CenExel iResearch, LLC Decatur Georgia Not Yet Recruiting
AGILE Clinical Research Trials, LLC Sandy Springs Georgia Recruiting
Charter Research - Chicago Chicago Illinois Recruiting
Pharmasite Research, Inc. Baltimore Maryland Recruiting
Adams Clinical Boston Boston Massachusetts Recruiting
Adams Clinical Watertown Watertown Massachusetts Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan Recruiting
Be Well Clinical Studies - Omaha Omaha Nebraska Recruiting
Adams Clinical Bronx The Bronx New York Recruiting
Adams Clinical Philadelphia Philadelphia Pennsylvania Recruiting
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania Recruiting
Suburban Research Associates West Chester Pennsylvania Recruiting
FutureSearch Trials of Neurology Austin Texas Not Yet Recruiting
Gadolin Research Beaumont Texas Recruiting
Adams Clinical Dallas DeSoto Texas Recruiting
The University of Texas Rio Grande Valley Harlingen Texas Not Yet Recruiting
Olympus Clinical Research Katy Texas Recruiting
Boeson Research - Provo Provo Utah Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
Ramsay Clinic New Farm Brisbane Australia Not Yet Recruiting
Paratus Clinical Research Canberra Bruce Australia Not Yet Recruiting
NeuroCentrix Carlton Australia Not Yet Recruiting
Lyell McEwin Hospital Elizabeth Vale Australia Not Yet Recruiting
Barwon Health Geelong Australia Not Yet Recruiting
Multidisciplinary Alfred Psychiatry Research Centre Melbourne Australia Not Yet Recruiting

+ 130 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07775300 on ClinicalTrials.gov ↗ ← All trials in South Korea