Recruiting

Phase 2

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

Sponsor:

Eli Lilly and Company

Code:

NCT07286175

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brenipatide

Placebo

Study Details

Brief summary:

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.

Conditions

Bipolar Disorder

Study ID

NCT07286175

Start date

Nov 24, 2025

Status verified date

Sep, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brenipatide Dose 1

Brenipatide administered subcutaneous (SC) + SoC.

experimental: Brenipatide Dose 2 .

Brenipatide administered subcutaneous (SC) + SoC.

placebo comparator: Placebo

Placebo administered SC + SoC.

Interventions

Brenipatide

Administered SC

Placebo

Administered SC

Primary outcome measure

Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion [ Time Frame: Randomization up to at least 6 months ]

Central Contacts and Locations

Central contacts

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

Locations

ATP Clinical Research

Recruiting

Orange, California, United States, 92866

Contacts

949-354-5353

Principal Investigator:

Gustavo Alva

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

203-932-5711

Principal Investigator:

Mohini Ranganathan

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012

Contacts

3058196990 X 1

Principal Investigator:

WILSON CUEVA

Accel Research Sites - Maitland Clinical Research Unit

Recruiting

Maitland, Florida, United States, 32751

Contacts

386-785-2400

Principal Investigator:

Andrea Marraffino

K2 Medical Research - Maitland

Recruiting

Maitland, Florida, United States, 32751

Principal Investigator:

Sejal Patel

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016-1518

Contacts

305-330-9977

Principal Investigator:

Hortensia Valeron

CLA Research

Recruiting

Naples, Florida, United States, 34116

Contacts

239-837-8818

Principal Investigator:

Evelia Iglesias

Charter Research - Orlando

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

Jorel Martinez

Encore Medical Research - Weston

Recruiting

Weston, Florida, United States, 33331

Contacts

954-777-8827

Principal Investigator:

Luis Marchany Alfonso

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Principal Investigator:

Elyssa Barron

Covenant Medical Center

Recruiting

Waterloo, Iowa, United States, 50702

Contacts

319-272-2112

Principal Investigator:

NICHOLAS GOETSCH

CBH Health

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

301-251-4702

Principal Investigator:

Elia Acevedo Diaz

Elixia MA

Recruiting

Springfield, Massachusetts, United States, 01103

Contacts

413-305-1142

Principal Investigator:

Susan Smiga

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

617-744-8542

Principal Investigator:

Dyanna Domilici

Penn Medicine: University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

yvette sheline

Revival Research Institute, LLC

Recruiting

McKinney, Texas, United States, 75071

Principal Investigator:

Jawad Riaz

Pillar Clinical Research - Richardson

Recruiting

Richardson, Texas, United States, 75080

Contacts

214-396-4844

Principal Investigator:

Scott Bartley

Alpine Research Organization

Recruiting

Clinton, Utah, United States, 84015

Contacts

801-928-3292

Principal Investigator:

Michael Roundy

Re:Cognition Health

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Scott Williams

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

425-453-0404

Principal Investigator:

Wisam Al jumaili

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.