Recruiting
Phase 2

Brenipatide

Sponsor:

Eli Lilly and Company

Code:

NCT07410507

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 55

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 to placebo plus SoC for treatment of schizophrenia.

The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Conditions

Schizophrenia

Study ID

NCT07410507

Start date

Feb 10, 2026

Status verified date

Sep, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Meet the diagnostic criteria of schizophrenia
  • Are on a stable standard of care medication regimen for schizophrenia
  • If the duration of illness is >6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
  • Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
  • 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 study intervention as directed,
  • maintain electronic or paper study diaries, as applicable, and
  • complete the required questionnaires

Exclusion Criteria:

  • Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
  • Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
  • Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
  • Are actively suicidal or deemed to be a significant risk for suicide
  • Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brenipatide

Brenipatide administered subcutaneously (SC) + SoC.

placebo comparator: Placebo

Placebo administered SC + SoC.

Interventions

Brenipatide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²) [ Time Frame: Baseline, Week 52 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Pillar Clinical Research- Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

Principal Investigator:

Leslie Smith

Clinical Innovations, Inc. dba CITrials

Recruiting

Bellflower, California, United States, 90706

Contacts

562-249-6956

Principal Investigator:

Gerald Maguire

Collaborative Neuroscience Research, LLC

Recruiting

Garden Grove, California, United States, 92845

Contacts

714-799-7799

Principal Investigator:

David Walling

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

650-723-3305

Principal Investigator:

Jacob Ballon

Collaborative Neuroscience Research, LLC

Recruiting

Torrance, California, United States, 90502

Contacts

310-523-4200

Principal Investigator:

Lara Shirikjian

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

Contacts

925-298-5147

Principal Investigator:

Ira Glick

Institute of Living

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Benjamin Anderson

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06511

Principal Investigator:

Youngsun Cho

Magno Medical Research Group

Recruiting

Cooper City, Florida, United States, 33024

Contacts

954-589-0658

Principal Investigator:

Richard Douyon

Innovative Clinical Research

Recruiting

Lauderhill, Florida, United States, 33319

Contacts

786-570-1971

Principal Investigator:

Rishi Kakar

Accel Research Sites - Maitland Clinical Research Unit

Recruiting

Maitland, Florida, United States, 32751

Contacts

386-785-2400

Principal Investigator:

Andrea Marraffino

Wellness Research Center

Recruiting

Miami, Florida, United States, 33135

Contacts

305-300-2623

Principal Investigator:

Emilio Mantero-Atienza

Vital Medical Research

Recruiting

Miami, Florida, United States, 33174

Contacts

305-703-4414

Principal Investigator:

Linda Collado

CLA Research

Recruiting

Naples, Florida, United States, 34116

Contacts

239-837-8818

Principal Investigator:

Evelia Iglesias

Apg Research, Llc

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

MORTEZA NADJAFI

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Principal Investigator:

Elyssa Barron

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Principal Investigator:

Joseph McEvoy

Re:Cognition Health - Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Abid Nazeer

CBH Health

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

301-251-4702

Principal Investigator:

Elia Acevedo Diaz

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Principal Investigator:

Virginie-Anne Chouinard

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

617-744-8542

Principal Investigator:

Dyanna Domilici

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

508-856-3881

Principal Investigator:

Xiaoduo Fan

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

314-282-3521

Principal Investigator:

Junaid Syed

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

Contacts

917-423-67697

Principal Investigator:

Rachel Noone

Insight Clinical Trials

Recruiting

Independence, Ohio, United States, 44131

Contacts

216-526-1843

Principal Investigator:

Mark Stillman

University of Oregon

Recruiting

Eugene, Oregon, United States, 97403

Contacts

310-844-6458

Principal Investigator:

Fred Sabb

Adams Clinical Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Cassie Blanchard

Adams Clinical Dallas

Recruiting

DeSoto, Texas, United States, 75115

Principal Investigator:

Benji Kurian

Re:Cognition Health - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

682-394-3500

Principal Investigator:

Sondra Bell

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

425-453-0404

Principal Investigator:

Arun Arora

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 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.