A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Public ClinicalTrials.gov record NCT07412756. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07412756
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 8, 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2028
- Last update posted
- Aug 5, 2026
2026 – 2028
United States locations
- U.S. sites
- 32
- U.S. states
- 19
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Accellacare - Moorpark | Moorpark | California | 93021 | Recruiting |
| ATP Clinical Research | Orange | California | 92866 | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | Recruiting |
| Encore Medical Research | Hollywood | Florida | 33024 | Recruiting |
| K2 Medical Research - Maitland | Maitland | Florida | 32751 | Recruiting |
| Life Medical Research Group Corp | Miami Gardens | Florida | 33014 | Recruiting |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016-1518 | Recruiting |
| CLA Research | Naples | Florida | 34116 | Recruiting |
| Optimal Research Sites | Orange City | Florida | 32763 | Recruiting |
| Charter Research - Orlando | Orlando | Florida | 32803 | Recruiting |
| K2 Medical Research - Tampa | Tampa | Florida | 33634 | Recruiting |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | Recruiting |
| Indiana University Health Neuroscience Center | Indianapolis | Indiana | 46202 | Recruiting |
| Cedar Valley Medical Specialists | Waterloo | Iowa | 50701 | Recruiting |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | Recruiting |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | Recruiting |
| K2 Medical Research - Foxborough | Foxborough | Massachusetts | 02035 | Recruiting |
| Adams Clinical Watertown | Watertown | Massachusetts | 02472 | Recruiting |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | Recruiting |
| Arch Clinical Trials | St Louis | Missouri | 63141 | Recruiting |
| Vector Clinical Trials | Las Vegas | Nevada | 89128 | Recruiting |
| Adams Clinical Harlem | New York | New York | 10029 | Recruiting |
| Summit Headlands | Portland | Oregon | 97210 | Recruiting |
| Suburban Research Associates | Media | Pennsylvania | 19063 | Recruiting |
| Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Circle Clinical Research | Sioux Falls | South Dakota | 57104 | Not yet recruiting |
| Adams Clinical Dallas | DeSoto | Texas | 75115 | Recruiting |
| Re:Cognition Health - Fort Worth | Fort Worth | Texas | 76104 | Recruiting |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | Recruiting |
| Alpine Research Organization | Clinton | Utah | 84015 | Recruiting |
| Re:Cognition Health | Fairfax | Virginia | 22031 | Recruiting |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 147 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07412756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07412756 live on ClinicalTrials.gov.