Brenipatide added to usual care for adults with major depressive disorder
Tests brenipatide, added to usual care, in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Key facts
- Where
- Baltimore, Bellevue, Boston, Clinton, Decatur, DeSoto, Fairfax, Fort Worth, Foxborough, Hollywood, Indianapolis, Las Vegas, Maitland, Miami Gardens, Miami Lakes, Moorpark, Naples, New Haven, New York, Orange, Orange City, Orlando, Philadelphia, Portland, Shavano Park, Sioux Falls, St Louis, Tampa, Troy, Waterloo, Watertown, and West Chester, United StatesSee the 32 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07412756, who can take part
Where in United States
- Pharmasite Research, Inc.Baltimore, United StatesTaking people
- Northwest Clinical Research CenterBellevue, United StatesTaking people
- Adams Clinical BostonBoston, United StatesTaking people
- Alpine Research OrganizationClinton, United StatesTaking people
- CenExel iResearch, LLCDecatur, United StatesTaking people
- Adams Clinical DallasDeSoto, United StatesTaking people
- Re:Cognition HealthFairfax, United StatesTaking people
- Re:Cognition Health - Fort WorthFort Worth, United StatesTaking people
- K2 Medical Research - FoxboroughFoxborough, United StatesTaking people
- Encore Medical ResearchHollywood, United StatesTaking people
- Indiana University Health Neuroscience CenterIndianapolis, United StatesTaking people
- Vector Clinical TrialsLas Vegas, United StatesTaking people
- K2 Medical Research - MaitlandMaitland, United StatesTaking people
- Life Medical Research Group CorpMiami Gardens, United StatesTaking people
- Floridian Clinical Research, LLCMiami Lakes, United StatesTaking people
- Accellacare - MoorparkMoorpark, United StatesTaking people
- CLA ResearchNaples, United StatesTaking people
- Yale University School Of MedicineNew Haven, United StatesTaking people
- Adams Clinical HarlemNew York, United StatesTaking people
- ATP Clinical ResearchOrange, United StatesTaking people
- Orange CityOrange City, United StatesTaking people
- Charter Research - OrlandoOrlando, United StatesTaking people
- Penn Medicine: University of Pennsylvania Health SystemPhiladelphia, United StatesTaking people
- Summit HeadlandsPortland, United StatesTaking people
- Consano Clinical Research, LLCShavano Park, United StatesNo longer taking part
- Circle Clinical ResearchSioux Falls, United StatesTaking people
- Arch Clinical TrialsSt Louis, United StatesTaking people
- K2 Medical Research - TampaTampa, United StatesTaking people
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesTaking people
- Cedar Valley Medical SpecialistsWaterloo, United StatesNot yet recruiting
- Adams Clinical WatertownWatertown, United StatesTaking people
- Suburban Research AssociatesWest Chester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07412756EU 2025-522308-25-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)
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 four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.
Inclusion: 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: 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; 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.