A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) (NCT07286175)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).
Location: ATP Clinical Research — Orange, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:
- schizophrenia or other psychotic disorder
- borderline personality disorder, or
- any eating disorder
- Have type 1 diabetes mellitus, or a history of
- ketoacidosis, or
- hyperosmolar state or coma
- Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
- Are actively suicidal and or deemed to be at significant risk for suicide
- Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (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,
💰 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.