A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder (NCT07775300)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham - School of Medicine — Birmingham, Alabama
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (169 Sites)
Showing the first 25 of 169 sites.
- University of Alabama at Birmingham - School of Medicine — Birmingham, Alabama
- NoesisPharma, LLC — Phoenix, Arizona
- Irvine Clinical Research — Irvine, California
- Healthy Brain Clinic — Long Beach, California
- Oakland Clinical — Oakland, California
- Concierge Clinical Trials — Valley Village, California
- JEM Research Institute — Atlantis, Florida
- Bradenton Research Center, Inc. — Bradenton, Florida
- Key Clinical Research — Bradenton, Florida
- NextPhase Research Florida - Hollywood — Hollywood, Florida
- Miami Jewish health — Miami, Florida
- Quantix Research - Miami - Southwest 72nd Street — Miami, Florida
- Diverse Clinical Research — Miami, Florida
- De La Cruz Research Center, LLC — Miami, Florida
- CLA Research — Naples, Florida
- Charter Research - Orlando — Orlando, Florida
- Health Synergy Clinical Research — West Palm Beach, Florida
- AGILE Clinical Research Trials, LLC — Sandy Springs, Georgia
- Charter Research - Chicago — Chicago, Illinois
- Pharmasite Research, Inc. — Baltimore, Maryland
- Adams Clinical Boston — Boston, Massachusetts
- Adams Clinical Watertown — Watertown, Massachusetts
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan
- Be Well Clinical Studies - Omaha — Omaha, Nebraska
- Adams Clinical Bronx — The Bronx, New York
📞 Contact the Study Coordinator
Phone: (317) 615-4559
Email: LillyTrials@Lilly.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Depressive Disorder, Major
- Psilocybin for Major Depressive Disorder (MDD) — Birmingham, Alabama
- Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab — Boston, Massachusetts
- bWell-D Pilot Randomized Controlled Trial — Vancouver, British Columbia
- Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation — Belmont, Massachusetts
- Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms — Birmingham, Alabama
Explore by condition: All Depressive Disorder, Major clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.