SchizophreniaPhase 3NCT06572449

Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

A Phase 3 study testing KarXT in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: KarXT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: 6 sitesUnited States
Study dates: 28 Oct 2024to 13 Mar 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
Willing and able to discontinue all antipsychotic medications prior to baseline visit.

Who cannot join

History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
History of treatment resistance to schizophrenia medications.
History of allergy/hypersensitivity to KarXT.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Local Institution - 0005
Atlanta, Georgia, 30331
Local Institution - 0003
Decatur, Georgia, 30030
Local Institution - 0006
Hollywood, Florida, 33024
Local Institution - 0002
Los Alamitos, California, 90720-3118
Local Institution - 0001
Marlton, New Jersey, 08053-3449
Local Institution - 0004
Riverside, California, 92506-3257

Other trials in United States

About this study

Official title: A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.

Conditions: Schizophrenia
Being tested: KarXT
Keywords: BMS-986510, KarXT, DSM-5 Schizophrenia, Diagnostic and Statistical Manual of Mental Disorders, Mental Disorders
Medical subject headings: Schizophrenia, Disease, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KarXTDrug
Also called BMS-986510
Specified dose on specified days

Study groups in NCT06572449
Study group	Role	What they receive
KarXT on empty stomach and with food	Experimental	Not described Receives: Drug: KarXT

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With TEAEs From First Dose to End of Study Follow up.
Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up.
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Measured: From first dose to end of study follow up (63 days)
Number of Participants With TEAEs at the End of Period 1 and Period 2.
Number of participants with TEAEs at the end of period 1 and period 2.
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Measured: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
Number of participants with TEAEs at the end of period 1 and period 2.
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of Participants With TEAEs Leading to Treatment Discontinuation.
Number of participants with TEAEs leading to treatment discontinuation.
Measured: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.
Measured: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

Secondary outcomes (8)

Change From Baseline in PANSS Total Score, Positive Score and Negative Score
The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales. Each item is rated from 1 (absent) to 7 (extreme). Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function. The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity. The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.
Measured: From first dose to end of treatment (56 days)
Change From Baseline in Marder Factor Score.
PANSS Marder factor score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale, with a total score ranging from 7 to 49. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Baseline is defined as the PANSS score at screening.
Measured: From first dose to end of treatment (56 days)
Change From Baseline in CGI Severity Score
Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness.
Measured: From first dose to end of treatment (56 days)
Number of Participants With Spontaneously Reported AESIs
The AEs of special interest (AESIs) will be monitored and include symptomatic orthostasis, syncope(a transient loss of consciousness or fainting),and liver function test elevations as defined below. For SAE reporting requirements for events of liver injury.
Measured: From first dose to end of study follow up (63 days)
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs
Measured: From first dose to end of study follow up (63 days)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Number of participants with clinically significant changes in clinical laboratory assessments
Measured: From first dose to end of study follow up (63 days)
Number of Participants With Clinically Significant Changes in 12-lead ECGs
Number of participants with clinically significant changes in 12-lead ECGs
Measured: From first dose to end of study follow up (63 days)
Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS
Number of participants who exhibited suicidal behavior as assessed by C-SSRS
Measured: From first dose to end of study follow up (63 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202413 Mar 2025

First posted27 Aug 2024
Study start28 Oct 2024
Primary completion13 Mar 2025
Study completion13 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06572449
Sponsor's protocol ID: CN012-0048
Status last verified: Jun 2026
First submitted: 8 Aug 2024
Last updated: 22 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia
ClinicalTrials.gov ID: NCT06572449
Acronym / sponsor ID: CN012-0048
Conditions: Schizophrenia
Keywords: BMS-986510, KarXT, DSM-5 Schizophrenia, Diagnostic and Statistical Manual of Mental Disorders, Mental Disorders
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
Study start: 28 Oct 2024 (actual)
Primary completion: 13 Mar 2025 (actual)
Study completion: 13 Mar 2025 (actual)
First posted: 27 Aug 2024 (actual)
Results: Posted 22 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
KarXT on empty stomach and with food	Experimental	Drug: KarXT

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
Willing and able to discontinue all antipsychotic medications prior to baseline visit.

Key exclusion criteria (5 listed)

History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
History of treatment resistance to schizophrenia medications.
History of allergy/hypersensitivity to KarXT.
Other protocol-defined Inclusion/Exclusion criteria apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KarXTAlso: BMS-986510Specified dose on specified days	Drug	KarXT on empty stomach and with food

Primary outcome

Number of Participants With TEAEs From First Dose to End of Study Follow up.
Time frame: From first dose to end of study follow up (63 days)
Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Number of Participants With TEAEs at the End of Period 1 and Period 2.
Time frame: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)
Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Number of Participants With TEAEs Leading to Treatment Discontinuation.
Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of participants with TEAEs leading to treatment discontinuation.
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.

8 secondary outcomes

Change From Baseline in PANSS Total Score, Positive Score and Negative Score
Time frame: From first dose to end of treatment (56 days)
Change From Baseline in Marder Factor Score.
Time frame: From first dose to end of treatment (56 days)
Change From Baseline in CGI Severity Score
Time frame: From first dose to end of treatment (56 days)
Number of Participants With Spontaneously Reported AESIs
Time frame: From first dose to end of study follow up (63 days)
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From first dose to end of study follow up (63 days)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: From first dose to end of study follow up (63 days)
Number of Participants With Clinically Significant Changes in 12-lead ECGs
Time frame: From first dose to end of study follow up (63 days)
Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS
Time frame: From first dose to end of study follow up (63 days)

Results and safety

Results posted to the registry on 22 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	100	83
Cohort 2	73	56

Primary outcome: Number of Participants With TEAEs From First Dose to End of Study Follow up.

Time frame: From first dose to end of study follow up (63 days). Count of participants. Unit: Participants

Measure	Cohort 1 n = 100	Cohort 2 n = 73
TEAE	72	55
Treatment Related TEAEs	61	44

Population analysed: All Treated Participants

Primary outcome: Number of Participants With TEAEs at the End of Period 1 and Period 2.

Time frame: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56). Count of participants. Unit: Participants

Measure	Cohort 1 n = 100	Cohort 2 n = 73
Period 1 (First dose to day 28)	62	49
Period 2 (from day 29 to day 56)	34	26

Population analysed: All Treated Participants

Primary outcome: Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.

Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days). Count of participants. Unit: Participants

Measure	Cohort 1 n = 100	Cohort 2 n = 73
Period 1 (First dose to day 28)	0	0
Period 2 (from day 29 to day 56)	0	0
From First dose to day 63	0	0

Population analysed: All Treated Participants

Primary outcome: Number of Participants With TEAEs Leading to Treatment Discontinuation.

Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days). Count of participants. Unit: Participants

Measure	Cohort 1 n = 100	Cohort 2 n = 73
Period 1 (First dose to day 28)	1	2
Period 2 (from day 29 to day 56)	0	3
From First dose to day 63	1	5

Population analysed: All Treated Participants

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs and SAEs are collected on or after the first dosing date through the end of the safety follow up (Day 63 ± 3 days) or EOT+7 (Day 56+7 ±3 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 100 (0%)	54 of 100 (54%)	0 of 100
Cohort 2	0 of 73 (0%)	44 of 73 (60.3%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KarXT in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With TEAEs From First Dose to End of Study Follow up. (time frame: From first dose to end of study follow up (63 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06572449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.