A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Public ClinicalTrials.gov record NCT07775300. 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- 2)
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
- NCT07775300
- Recruitment status
- Not yet 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
- Jul 31, 2026
- Primary completion
- Nov 30, 2028
- Completion
- Jan 31, 2029
- Last update posted
- Aug 19, 2026
2026 – 2029
United States locations
- U.S. sites
- 36
- U.S. states
- 15
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - School of Medicine | Birmingham | Alabama | 35294 | — |
| NoesisPharma, LLC | Phoenix | Arizona | 85028 | — |
| Irvine Clinical Research | Irvine | California | 92614 | — |
| Healthy Brain Clinic | Long Beach | California | 90804 | — |
| Oakland Clinical | Oakland | California | 94609 | — |
| Concierge Clinical Trials | Valley Village | California | 91607 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | — |
| Key Clinical Research | Bradenton | Florida | 34207 | — |
| NextPhase Research Florida - Hollywood | Hollywood | Florida | 33024 | — |
| Miami Jewish health | Miami | Florida | 33137 | — |
| Quantix Research - Miami - Southwest 72nd Street | Miami | Florida | 33173 | — |
| Diverse Clinical Research | Miami | Florida | 33175 | — |
| De La Cruz Research Center, LLC | Miami | Florida | 33184 | — |
| CLA Research | Naples | Florida | 34116 | — |
| Charter Research - Orlando | Orlando | Florida | 32803 | — |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | — |
| AGILE Clinical Research Trials, LLC | Sandy Springs | Georgia | 30328 | — |
| Charter Research - Chicago | Chicago | Illinois | 60618 | — |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | — |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | — |
| Adams Clinical Watertown | Watertown | Massachusetts | 02472 | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | — |
| Be Well Clinical Studies - Omaha | Omaha | Nebraska | 68144 | — |
| Adams Clinical Bronx | The Bronx | New York | 10461 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18103 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Adams Clinical Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Gadolin Research | Beaumont | Texas | 77702 | — |
| Adams Clinical Dallas | DeSoto | Texas | 75115 | — |
| The University of Texas Rio Grande Valley | Harlingen | Texas | 78550 | — |
| Olympus Clinical Research | Katy | Texas | 77450 | — |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | — |
| Boeson Research - Provo | Provo | Utah | 84604 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
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 133 non-U.S. sites.
Recently updated Depressive Disorder, Major trials
Other public records listing Depressive Disorder, Major. Sorted by last update posted; newest first. Not a recommendation.
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- NCT07227454: A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder Recruiting
- NCT06785012: A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07775300, 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 19, 2026 · Synced Aug 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07775300 live on ClinicalTrials.gov.