Recruiting
Phase 1

KarXT

Sponsor:

Bristol-Myers Squibb

Code:

NCT07061288

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

KarXT

Study Details

Brief summary:

A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia

Conditions

Schizophrenia

Study ID

NCT07061288

Start date

Sep 3, 2025

Status verified date

Aug, 2026

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Jun 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2).
  • Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline.
  • Participants must have a body mass index (BMI) between 18 and 40 kg/m².
  • Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements.

Exclusion Criteria

  • Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia.
  • Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder.
  • Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results.
  • Participants must not be at risk for suicidal behavior.
  • Female participants must not be pregnant or breastfeeding.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

131 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of KarXT

Interventions

KarXT

Specified dose on specified days

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Up to 3 weeks ]
  • Number of participants with adverse events of special interest (AESIs) [ Time Frame: Up to 3 weeks ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 3 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Collaborative Neuroscience Research, LLC

Recruiting

Los Alamitos, California, United States, 90720-3118

Contacts

David Walling, Site 0001

714-799-7799

Research Centers of America ( Hollywood )

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Edwin Gomez, Site 0005

954-990-7649

Innovative Clinical Research, Inc.

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Rishi Kakar, Site 0004

786-512-4106

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Elyssa Barron, Site 0008

404-881-5800

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Kimball Johnson, Site 0003

312-942-5592

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Contacts

John Sonnenberg, Site 0002

773-968-9868

Hassman Research Institute Marlton Site

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Elan Cohen, Site 0007

856-452-9901

Community Clinical Research

Recruiting

Austin, Texas, United States, 78754

Contacts

David Brown, Site 0006

512-323-2622

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • KarXT
  • Long-acting injectable (LAI)
  • Cobenfy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-02.