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Clinical Trials in the UK / NCT07412756
Recruiting Phase 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

NCT07412756 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-02-09
Last updated
2026-08-06

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 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

Primary outcome measure(s)

Trial sites (179)

FacilityCityRegionStatus
Accellacare - Moorpark Moorpark California Recruiting
ATP Clinical Research Orange California Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
Encore Medical Research Hollywood Florida Recruiting
K2 Medical Research - Maitland Maitland Florida Recruiting
Life Medical Research Group Corp Miami Gardens Florida Recruiting
Floridian Clinical Research, LLC Miami Lakes Florida Recruiting
CLA Research Naples Florida Recruiting
Optimal Research Sites Orange City Florida Recruiting
Charter Research - Orlando Orlando Florida Recruiting
K2 Medical Research - Tampa Tampa Florida Recruiting
CenExel iResearch, LLC Decatur Georgia Recruiting
Indiana University Health Neuroscience Center Indianapolis Indiana Recruiting
Cedar Valley Medical Specialists Waterloo Iowa Recruiting
Pharmasite Research, Inc. Baltimore Maryland Recruiting
Adams Clinical Boston Boston Massachusetts Recruiting
K2 Medical Research - Foxborough Foxborough Massachusetts Recruiting
Adams Clinical Watertown Watertown Massachusetts Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan Recruiting
Arch Clinical Trials St Louis Missouri Recruiting
Vector Clinical Trials Las Vegas Nevada Recruiting
Adams Clinical Harlem New York New York Recruiting
Summit Headlands Portland Oregon Recruiting
Suburban Research Associates Media Pennsylvania Recruiting
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania Recruiting
Circle Clinical Research Sioux Falls South Dakota Not Yet Recruiting
Adams Clinical Dallas DeSoto Texas Recruiting
Re:Cognition Health - Fort Worth Fort Worth Texas Recruiting
Consano Clinical Research, LLC Shavano Park Texas Recruiting
Alpine Research Organization Clinton Utah Recruiting
Re:Cognition Health Fairfax Virginia Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
NeuroCentrix Carlton Australia Recruiting
Lyell McEwin Hospital Elizabeth Vale Australia Not Yet Recruiting
Barwon Health Geelong Australia Recruiting
Multidisciplinary Alfred Psychiatry Research Centre Melbourne Australia Recruiting
Paratus Clinical Research - Melbourne Melbourne Australia Recruiting
Toowoomba Hospital Toowoomba Australia Recruiting
Westmead Hospital Westmead Australia Recruiting
Hospital das Clínicas da UFMG Belo Horizonte Brazil Not Yet Recruiting

+ 139 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the UK

Other trials for the same condition

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 NCT07412756 on ClinicalTrials.gov ↗ ← All trials in the UK