CompletedPhase 3

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

United States173 participantsStarted 2024-10-28

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

Trial details

NCT IDNCT06572449

SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-13

Results submitted2026-03-09

View on ClinicalTrials.gov More Schizophrenia trials