A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

ClinicalTrials.gov ID: NCT07775300

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.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:09 AM EDT

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: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Eli Lilly and Company; Industry
Enrollment: 1,000 participants

Conditions and interventions

Conditions

Depressive Disorder, Major

Interventions

Brenipatide Drug
Placebo Drug

Drug

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: Aug 14, 2026 (Actual)
Primary completion: Dec 2028 (Estimated)
Completion: Feb 2029 (Estimated)
Last update posted: Oct 7, 2026

2026 – 2029

United States locations

U.S. sites: 34
U.S. states: 15
U.S. cities: 30

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama	35294	Recruiting
NoesisPharma, LLC	Phoenix	Arizona	85028	Recruiting
Irvine Clinical Research	Irvine	California	92614	Recruiting
Healthy Brain Clinic	Long Beach	California	90804	Not yet recruiting
Oakland Clinical	Oakland	California	94609	Recruiting
Concierge Clinical Trials	Valley Village	California	91607	Recruiting
JEM Research Institute	Atlantis	Florida	33462	Recruiting
Bradenton Research Center, Inc.	Bradenton	Florida	34205	Recruiting
Key Clinical Research	Bradenton	Florida	34207	Recruiting
NextPhase Research Florida - Hollywood	Hollywood	Florida	33024	Recruiting
Miami Jewish health	Miami	Florida	33137	Not yet recruiting
Quantix Research - Miami - Southwest 72nd Street	Miami	Florida	33173	Recruiting
Diverse Clinical Research	Miami	Florida	33175	Recruiting
CLA Research	Naples	Florida	34116	Recruiting
Health Synergy Clinical Research	West Palm Beach	Florida	33407	Recruiting
CenExel iResearch, LLC	Decatur	Georgia	30030	Not yet recruiting
AGILE Clinical Research Trials, LLC	Sandy Springs	Georgia	30328	Recruiting
Charter Research - Chicago	Chicago	Illinois	60618	Recruiting
Pharmasite Research, Inc.	Baltimore	Maryland	21208	Recruiting
Adams Clinical Boston	Boston	Massachusetts	02116	Recruiting
Adams Clinical Watertown	Watertown	Massachusetts	02472	Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan	48098	Recruiting
Be Well Clinical Studies - Omaha	Omaha	Nebraska	68144	Recruiting
Adams Clinical Bronx	The Bronx	New York	10461	Recruiting
Adams Clinical Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Penn Medicine: University of Pennsylvania Health System	Philadelphia	Pennsylvania	19104	Recruiting
Suburban Research Associates	West Chester	Pennsylvania	19380	Recruiting
FutureSearch Trials of Neurology	Austin	Texas	78731	Not yet recruiting
Gadolin Research	Beaumont	Texas	77702	Recruiting
Adams Clinical Dallas	DeSoto	Texas	75115	Recruiting
The University of Texas Rio Grande Valley	Harlingen	Texas	78550	Not yet recruiting
Olympus Clinical Research	Katy	Texas	77450	Recruiting
Boeson Research - Provo	Provo	Utah	84604	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 136 non-U.S. sites.

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 Oct 7, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07775300 live on ClinicalTrials.gov.

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