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NCT Number: NCT07802132

A Prospective, Observational, Single-Arm, Multicenter Real-World Study Evaluating the Treatment Pattern, Safety and Effectiveness of Xanomeline and Trospium Chloride Capsules (KarXT) in the Treatment of Chinese Adult Participants With Schizophrenia

This study is a prospective, observational, single-arm, open-label, multicenter, real-world study conducted in Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria. The total study duration is up to 17 weeks, including a screening/baseline data collection period followed by an observational part during which KarXT treatmentpattern, schizophrenia treatment decisions and compliance will be observed in the real-world setting.

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Key information

Conditions

Schizophrenia Disorder Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia.
  • The participant is capable of providing written informed consent in the study, agrees to receive KarXT monotherapy, is willing to follow the protocol-specified follow-up schedule, and signs the informed consent form, or, where applicable, both the participant and the participant's legal guardian sign the informed consent form.

Exclusion criteria

  • Participants who have contraindications listed in the prescribing information: urinary retention, moderate or severe hepatic impairment, gastric retention, history of hypersensitivity to this product or trospium chloride, or untreated narrow-angle glaucoma.
  • Participants who have conditions not recommended in the prescribing information, such as moderate or severe renal impairment, mild hepatic impairment, or active biliary disease (e.g., symptomatic gallstones).
  • Participants diagnosed with treatment-resistant schizophrenia (TRS), defined as having previously received at least two courses of treatment with different antipsychotic medications, with each course administered at an adequate dose, as determined by the investigator based on clinical judgment, for at least 4 weeks, but without response.
  • Participants with severe suicidal ideations. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" on items 4 or 5 (C -SSRS ideation) with the most recent episode occurring within the 2 months before screening, or answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before screening. Non-suicidal self-injurious behavior is not exclusionary.
  • Participants who are pregnant, planning to become pregnant, or breastfeeding.
  • Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.

Treatment and study plan

Xanomeline and trospium chloride (KarXT)

Drug

Participants will receive KarXT for a treatment/observation period of 17 weeks. The recommended dosage and administration of KarXT should refer to the prescribing information:

The recommended starting dosage is one 50 mg/20 mg capsule orally twice daily for at least two days, then increase to one 100 mg/20 mg capsule orally twice daily for at least five days, the dosage may be increased to one 125 mg/30 mg capsule orally twice daily based on participant tolerability and response. All participants who are increased to 125 mg/30 mg, depending on clinician's decision, will have the option to return to 100 mg/20 mg for the remainder of the treatment/observation period. Maintenance doses may be set at 125 mg/30 mg or 100 mg/20 mg twice daily.

Primary outcomes

  1. KarXTtreatment pattern according to clinicians'decision

    Time frame: through Week 17

    Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17

  2. KarXTtreatment pattern according to clinicians'decision

    Time frame: Week 17

    Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17

Secondary outcomes

  1. KarXT Safety Profile

    Time frame: through Week 17

    Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17

  2. KarXT Treatment PatternAccording to Clinicians'Decision

    Time frame: through Week 5

    Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5

  3. KarXT Safety Profile

    Time frame: through Week 17

    Proportion (%)of serious adverse events (SAEs) through Week 17

  4. KarXT Treatment Effectiveness

    Time frame: Week 17

    Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17

  5. KarXT Treatment Effectiveness

    Time frame: Week 17

    Change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 17

  6. Schizophrenia Treatment Decisions and Compliance in the Real-world Setting

    Time frame: through Week 17

    Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17

  7. KarXT Treatment PatternAccording to Clinicians'Decision

    Time frame: through Week 5

    Proportion (%) of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5

Other outcomes

  1. Change from baseline in social functional recovery metrics captured via continuous wearable wristband device

    Time frame: Baseline and Week 17

    Change from baseline in social functional recovery metrics captured via continuous wearable wristband device (sleep onset time, wake time, total sleep duration, heart rate, heart rate variability, total daily step count, sedentary duration, and activity interruptions)

  2. Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions

    Time frame: Baseline and Week 17

    Observed Ecological Momentary Assessment (EMA) patient-reported outcomes (PRO) in participants with schizophrenia: Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions: location (at home vs. outdoors), sociality context (alone vs. with others), activity type (productive vs. non-productive), and affect profile (positive vs. negative) at Week 17

  3. Change From Baseline in the Zarit Caregiver Burden Interview (ZBI) Score

    Time frame: Baseline and Week 17

    Change from baseline in caregiver burden, assessed by the Zarit Caregiver Burden Interview (ZBI)

  4. Change From Baseline in the PANSS Marder Negative Factor Score

    Time frame: Baseline and Week 17

    Change from baseline in the PANSS Marder negative factor score

  5. Change From Baseline in the Personal and Social Performance Scale (PSP) Score

    Time frame: Baseline and Week 17

    Change from baseline in the Personal and Social Performance Scale (PSP) score

  6. Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) Score

    Time frame: Baseline and Week 17

    Change from baseline in participant treatment satisfaction measured by the Medication Satisfaction Questionnaire (MSQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Shi WANG

CONTACT

[email protected]

+8618601287374

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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