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RecruitingPhase 2

A Study of Brenipatide in Adult Participants With Schizophrenia

Eli Lilly and Company · NCT07410507

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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 18–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
450
US sites recruiting
32
Study start
February 10, 2026
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 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.

Being studied: Brenipatide; Placebo

Conditions: Schizophrenia

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 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

Recruiting US locations

  • Pillar Clinical Research- Little Rock

    Little Rock, AR 72204

    Site contact: Leslie Smith

  • Clinical Innovations, Inc. dba CITrials

    Bellflower, CA 90706

    Site contact: 562-249-6956

  • Collaborative Neuroscience Research, LLC

    Garden Grove, CA 92845

    Site contact: 714-799-7799

  • Catalina Research Institute, LLC

    Montclair, CA 91763

    Site contact: Stephen Volk

  • Stanford University School of Medicine

    Stanford, CA 94305

    Site contact: 650-723-3305

  • Collaborative Neuroscience Research, LLC

    Torrance, CA 90502

    Site contact: 310-523-4200

  • Sunwise Clinical Research

    Walnut Creek, CA 94596

    Site contact: 925-298-5147

  • Institute of Living

    Hartford, CT 06106

    Site contact: Benjamin Anderson

  • Yale University School of Medicine

    New Haven, CT 06511

    Site contact: Youngsun Cho

  • Magno Medical Research Group

    Cooper City, FL 33024

    Site contact: 954-589-0658

  • NextPhase Research Florida - Hollywood

    Hollywood, FL 33024

    Site contact: Peter Ventre

  • Innovative Clinical Research

    Lauderhill, FL 33319

    Site contact: 786-570-1971

  • Accel Research Sites - Maitland Clinical Research Unit

    Maitland, FL 32751

    Site contact: 386-785-2400

  • Wellness Research Center

    Miami, FL 33135

    Site contact: 305-300-2623

  • Vital Medical Research

    Miami, FL 33174

    Site contact: 305-703-4414

  • CLA Research

    Naples, FL 34116

    Site contact: 239-837-8818

  • Apg Research, Llc

    Orlando, FL 32803

    Site contact: MORTEZA NADJAFI

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron

  • Augusta University

    Augusta, GA 30912

    Site contact: Joseph McEvoy

  • Re:Cognition Health - Chicago

    Chicago, IL 60611

    Site contact: Abid Nazeer

  • CBH Health

    Gaithersburg, MD 20877

    Site contact: 301-251-4702

  • McLean Hospital

    Belmont, MA 02478

    Site contact: Virginie-Anne Chouinard

  • Adams Clinical Watertown

    Watertown, MA 02472

    Site contact: 617-744-8542

  • University of Massachusetts Chan Medical School

    Worcester, MA 01655

    Site contact: 508-856-3881

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: 314-282-3521

  • Adams Clinical Harlem

    New York, NY 10029

    Site contact: 917-423-67697

  • Insight Clinical Trials

    Independence, OH 44131

    Site contact: 216-526-1843

  • University of Oregon

    Eugene, OR 97403

    Site contact: 310-844-6458

  • Adams Clinical Philadelphia

    Philadelphia, PA 19104

    Site contact: Cassie Blanchard

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Benji Kurian

  • Re:Cognition Health - Fort Worth

    Fort Worth, TX 76104

    Site contact: Syed Quadri

  • 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 Schizophrenia (NCT07410507) | Bored Studies