A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) (NCT07286175)
A Phase 2, 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 Bipolar Disorder (RENEW-Bipolar-1)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.
Who can join: Review the eligibility criteria below.
Location: ATP Clinical Research — Orange, California
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 (87 Sites)
Showing the first 25 of 87 sites.
- ATP Clinical Research — Orange, California
- Yale University School of Medicine — New Haven, Connecticut
- AGA Clinical Trials — Hialeah, Florida
- Accel Research Sites - Maitland Clinical Research Unit — Maitland, Florida
- K2 Medical Research - Maitland — Maitland, Florida
- Floridian Clinical Research, LLC — Miami Lakes, Florida
- CLA Research — Naples, Florida
- Charter Research - Orlando — Orlando, Florida
- Encore Medical Research - Weston — Weston, Florida
- Atlanta Center for Medical Research — Atlanta, Georgia
- Covenant Medical Center — Waterloo, Iowa
- CBH Health — Gaithersburg, Maryland
- Elixia MA — Springfield, Massachusetts
- Adams Clinical Watertown — Watertown, Massachusetts
- Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania
- Revival Research Institute, LLC — McKinney, Texas
- Pillar Clinical Research - Richardson — Richardson, Texas
- Alpine Research Organization — Clinton, Utah
- Re:Cognition Health — Fairfax, Virginia
- Northwest Clinical Research Center — Bellevue, Washington
- Hospital Italiano de Buenos Aires — ABB,
- Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires,
- Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires,
- Stat Research S.A. — Buenos Aires,
- Mautalen Salud e Investigación — Buenos Aires,
📞 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 Bipolar Disorder
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- Evaluation of the Genetics of Bipolar Disorder — Bethesda, Maryland
- Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth — Toronto, Ontario
- Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression — Belmont, Massachusetts
- Characterizing MyMood Patterns of Use — Toronto, Ontario
- A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder — Boston, Massachusetts
Explore by condition: All Bipolar Disorder 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.