A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT07286175

Run by

Eli Lilly and Company

People needed

400

Starts

2025-11-24

Expected to finish

2027-11-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II
• Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
• self-inject study intervention
• store and use the provided blinded study intervention, as directed
• maintain electronic and paper study diaries, as applicable, and
• complete the required questionnaires
• Are on stable standard of care medication for bipolar disorder

You may not qualify if…

• 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

Where it is running

• ATP Clinical Research — Orange, California, United States (enrolling)
• Instituto Médico DAMIC — Córdoba, Argentina (enrolling)
• Accel Research Sites - Maitland Clinical Research Unit — Maitland, Florida, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• AGA Clinical Trials — Hialeah, Florida, United States (enrolling)
• CLA Research — Naples, Florida, United States (enrolling)
• Charter Research - Orlando — Orlando, Florida, United States (enrolling)
• Encore Medical Research - Weston — Weston, Florida, United States (enrolling)
• K2 Medical Research - Maitland — Maitland, Florida, United States (enrolling)
• Covenant Medical Center — Waterloo, Iowa, United States (enrolling)
• Floridian Clinical Research, LLC — Miami Lakes, Florida, United States (enrolling)
• Elixia MA — Springfield, Massachusetts, United States (enrolling)
• Adams Clinical Watertown — Watertown, Massachusetts, United States (enrolling)
• Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States (enrolling)
• Revival Research Institute, LLC — McKinney, Texas, United States (enrolling)
• Pillar Clinical Research - Richardson — Richardson, Texas, United States (enrolling)
• Alpine Research Organization — Clinton, Utah, United States (enrolling)
• Re:Cognition Health — Fairfax, Virginia, United States (enrolling)
• Northwest Clinical Research Center — Bellevue, Washington, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires, Argentina (enrolling)
• Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires, Argentina (enrolling)
• CBH Health — Gaithersburg, Maryland, United States (enrolling)
• Mautalen Salud e Investigación — Buenos Aires, Argentina (enrolling)
• Instituto Kremer — Córdoba, Argentina (enrolling)

Full record on ClinicalTrials.gov

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