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

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)

Phase 2 Interventional Eli Lilly and Company · NCT07286175

This trial will test whether adding brenipatide to standard bipolar medications can delay worsening of symptoms in adults with bipolar I or II.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations88 sites (Orange, California and 87 other locations)
Trial IDNCT07286175 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with bipolar I or II who are on stable standard-of-care medication, can self-inject the study drug, and can attend regular clinic visits and complete study diaries are the ideal candidates.

Not a fit: People with current or lifetime schizophrenia or other psychotic disorders, borderline personality or eating disorders, type 1 diabetes, recent substance or alcohol use disorder, or those not on stable bipolar medications are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, brenipatide could help delay relapses and reduce worsening of symptoms for adults with bipolar disorder when added to standard treatments.

How similar studies have performed: The approach of adding a novel agent like brenipatide to standard care for bipolar disorder is relatively novel and large, definitive clinical successes in this exact approach have not yet been established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Orange, California and 87 other locations

+38 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.