A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Eli Lilly and Company trials in Spain
Other trials for the same condition
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 Spain