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RecruitingPhase 2

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

Eli Lilly and Company · NCT07286175

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
400
US sites recruiting
20
Study start
November 24, 2025
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Brenipatide; Placebo

Conditions: Bipolar Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • ATP Clinical Research

    Orange, CA 92866

    Site contact: 949-354-5353

  • Yale University School of Medicine

    New Haven, CT 06519

    Site contact: 203-932-5711

  • AGA Clinical Trials

    Hialeah, FL 33012

    Site contact: 3058196990 X 1

  • Accel Research Sites - Maitland Clinical Research Unit

    Maitland, FL 32751

    Site contact: 386-785-2400

  • K2 Medical Research - Maitland

    Maitland, FL 32751

    Site contact: Sejal Patel

  • Floridian Clinical Research, LLC

    Miami Lakes, FL 33016-1518

    Site contact: 305-330-9977

  • CLA Research

    Naples, FL 34116

    Site contact: 239-837-8818

  • Charter Research - Orlando

    Orlando, FL 32803

    Site contact: Jorel Martinez

  • Encore Medical Research - Weston

    Weston, FL 33331

    Site contact: 954-777-8827

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron

  • Covenant Medical Center

    Waterloo, IA 50702

    Site contact: 319-272-2112

  • CBH Health

    Gaithersburg, MD 20877

    Site contact: 301-251-4702

  • Elixia MA

    Springfield, MA 01103

    Site contact: 413-305-1142

  • Adams Clinical Watertown

    Watertown, MA 02472

    Site contact: 617-744-8542

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, PA 19104

    Site contact: Yvette Sheline

  • Revival Research Institute, LLC

    McKinney, TX 75071

    Site contact: Jawad Riaz

  • Pillar Clinical Research - Richardson

    Richardson, TX 75080

    Site contact: 214-396-4844

  • Alpine Research Organization

    Clinton, UT 84015

    Site contact: 801-928-3292

  • Re:Cognition Health

    Fairfax, VA 22031

    Site contact: Scott Williams

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: 425-453-0404

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Brenipatide in Adult Participants With Bipolar Disorder… (NCT07286175) | Bored Studies