Brenipatide for adults with bipolar disorder (RENEW-Bipolar-1)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RENEW-Bipolar-1 is a randomized, placebo-controlled Phase 2 trial comparing brenipatide plus standard of care (SoC) versus placebo plus SoC in adults with bipolar I or II. Participants complete a screening period of about one month, a minimum six-month treatment period during which they self-inject the blinded study intervention and complete diaries and questionnaires, and a follow-up period of about two months. Eligible participants must be on stable bipolar medication and willing to attend required study visits, while those with psychotic disorders, certain personality or eating disorders, type 1 diabetes, or recent substance use disorder are excluded. The trial measures whether brenipatide delays clinical worsening of bipolar symptoms and monitors safety throughout treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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

Where it's running

• ATP Clinical Research
  Orange, California, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting
• Accel Research Sites - Maitland Clinical Research Unit
  Maitland, Florida, United States Recruiting
• K2 Medical Research - Maitland
  Maitland, Florida, United States Recruiting
• Floridian Clinical Research, LLC
  Miami Lakes, Florida, United States Recruiting

+37 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.