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Clinical Trials in the UK / NCT07775300
Starting soon Phase 3

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

NCT07775300 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-08
Last updated
2026-08-27

Condition(s) studied

Depressive Disorder, Major

Investigational drug(s) / intervention(s)

BrenipatidePlacebo

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)

Trial sites (169)

FacilityCityRegionStatus
University of Alabama at Birmingham - School of Medicine Birmingham Alabama
NoesisPharma, LLC Phoenix Arizona
Irvine Clinical Research Irvine California
Healthy Brain Clinic Long Beach California
Oakland Clinical Oakland California
Concierge Clinical Trials Valley Village California
JEM Research Institute Atlantis Florida
Bradenton Research Center, Inc. Bradenton Florida
Key Clinical Research Bradenton Florida
NextPhase Research Florida - Hollywood Hollywood Florida
Miami Jewish health Miami Florida
Quantix Research - Miami - Southwest 72nd Street Miami Florida
Diverse Clinical Research Miami Florida
De La Cruz Research Center, LLC Miami Florida
CLA Research Naples Florida
Charter Research - Orlando Orlando Florida
Health Synergy Clinical Research West Palm Beach Florida
AGILE Clinical Research Trials, LLC Sandy Springs Georgia
Charter Research - Chicago Chicago Illinois
Pharmasite Research, Inc. Baltimore Maryland
Adams Clinical Boston Boston Massachusetts
Adams Clinical Watertown Watertown Massachusetts
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
Be Well Clinical Studies - Omaha Omaha Nebraska
Adams Clinical Bronx The Bronx New York
Lehigh Center for Clinical Research Allentown Pennsylvania
Suburban Research Associates Media Pennsylvania
Adams Clinical Philadelphia Philadelphia Pennsylvania
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania
Gadolin Research Beaumont Texas
Adams Clinical Dallas DeSoto Texas
The University of Texas Rio Grande Valley Harlingen Texas
Olympus Clinical Research Katy Texas
Consano Clinical Research, LLC Shavano Park Texas
Boeson Research - Provo Provo Utah
Northwest Clinical Research Center Bellevue Washington
Ramsay Clinic New Farm Brisbane Australia
Paratus Clinical Research Canberra Bruce Australia
NeuroCentrix Carlton Australia
Lyell McEwin Hospital Elizabeth Vale Australia

+ 129 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 the UK