A Study of Brenipatide in Participants With Major Depressive Disorder
Key facts
- Where
- Allentown, Atlanta, Austin, Bellevue, Boston, Cedarhurst, Chino, Dallas, Decatur, DeSoto, Fairfax, Hollywood, Jacksonville, Las Vegas, Marlton, Montclair, Mount Kisco, New York, Oceanside, Orlando, Philadelphia, Phoenix, Plant City, Savannah, Sherman Oaks, Staten Island, Tampa, Toms River, Watertown, West Hills, and West Palm Beach, United StatesSee the 35 sites
- Phase
- Phase 2
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: NCT07928245, who can take part
Where in United States
- Lehigh Center for Clinical ResearchAllentown, United StatesNo longer taking part
- Atlanta Center for Medical ResearchAtlanta, United StatesNo longer taking part
- Synexus Clinical ResearchAtlanta, United StatesNo longer taking part
- IMA Clinical Research Austin - NorthlandAustin, United StatesNo longer taking part
- Northwest Clinical Research CenterBellevue, United StatesNo longer taking part
- Adams Clinical BostonBoston, United StatesNo longer taking part
- Boston Clinical TrialsBoston, United StatesNo longer taking part
- Neurobehavioral Research, Inc.Cedarhurst, United StatesNo longer taking part
- Inland Psychiatric Medical Group.Chino, United StatesNo longer taking part
- Lonestar Clinical ResearchDallas, United StatesNo longer taking part
- CenExel iResearch, LLCDecatur, United StatesNo longer taking part
- Adams Clinical DallasDeSoto, United StatesNo longer taking part
- Inspire Behavioral HealthFairfax, United StatesNo longer taking part
- Research Centers of America, LLC-HollywoodHollywood, United StatesNo longer taking part
- The Medici Medical ResearchHollywood, United StatesNo longer taking part
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonville, United StatesNo longer taking part
- IMA Clinical Research - Las VegasLas Vegas, United StatesNo longer taking part
- Hassman Research Institute Marlton SiteMarlton, United StatesNo longer taking part
- Catalina Research Institute, LLCMontclair, United StatesNo longer taking part
- Bioscience Research LLCMount Kisco, United StatesNo longer taking part
- Adams Clinical HarlemNew York, United StatesNo longer taking part
- IMA Clinical Research - NYC MidtownNew York, United StatesNo longer taking part
- Excell ResearchOceanside, United StatesNo longer taking part
- Combined Research Orlando Phase I-IV LLCOrlando, United StatesNo longer taking part
- Adams Clinical PhiladelphiaPhiladelphia, United StatesNo longer taking part
- IMA Clinical Research PhoenixPhoenix, United StatesNo longer taking part
- Denali Health - Plant City, FLPlant City, United StatesNo longer taking part
- CenExel iResearch, LLCSavannah, United StatesNo longer taking part
- California Neuroscience Research Medical Group, Inc.Sherman Oaks, United StatesNo longer taking part
- Richmond Behavioral AssociatesStaten Island, United StatesNo longer taking part
- ForCare Clinical ResearchTampa, United StatesNo longer taking part
- Bio Behavioral HealthToms River, United StatesNo longer taking part
- Adams ClinicalWatertown, United StatesNo longer taking part
- Alliance Clinical West HillsWest Hills, United StatesNo longer taking part
- Neuroscience Research Institute - West Palm BeachWest Palm Beach, United StatesNo longer taking part
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
- NCT07928245EU 2026-527689-65-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide Compared With Placebo in Adult Participants With Major Depressive Disorder Who Have Partial Response to Antidepressant Therapy (RENEW-MDD-3)
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.
Inclusion: 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: Have had a history of any substance or alcohol use disorder of any severity within 180 days before Visit 1; 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; 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; Are actively suicidal or deemed a significant risk for suicide.