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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia Disorder
• Intervention / Treatment: Drug: Xanomeline and trospium chloride (KarXT)

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Hua Shi WANG; Phone Number: +8618601287374; Email: shihua.wang@zailaboratory.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria

Description

Inclusion Criteria:

1. Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia.
2. 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:

1. 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.
2. 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).
3. 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.
4. 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.
5. Participants who are pregnant, planning to become pregnant, or breastfeeding.
6. Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

KarXT Treatment Cohort; The participant is capable of providing written informed consent in this study, agrees to receive KarXT monotherapy

Drug: Xanomeline and trospium chloride (KarXT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KarXTtreatment pattern according to clinicians'decision	Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17	through Week 17
KarXTtreatment pattern according to clinicians'decision	Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17	Week 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KarXT Safety Profile	Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17	through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision	Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5	through Week 5
KarXT Safety Profile	Proportion (%)of serious adverse events (SAEs) through Week 17	through Week 17
KarXT Treatment Effectiveness	Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17	Week 17
KarXT Treatment Effectiveness	Change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 17	Week 17
Schizophrenia Treatment Decisions and Compliance in the Real-world Setting	Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17	through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision	Proportion (%) of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5	through Week 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device	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)	Baseline and Week 17
Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions	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	Baseline and Week 17
Change From Baseline in the Zarit Caregiver Burden Interview (ZBI) Score	Change from baseline in caregiver burden, assessed by the Zarit Caregiver Burden Interview (ZBI)	Baseline and Week 17
Change From Baseline in the PANSS Marder Negative Factor Score	Change from baseline in the PANSS Marder negative factor score	Baseline and Week 17
Change From Baseline in the Personal and Social Performance Scale (PSP) Score	Change from baseline in the Personal and Social Performance Scale (PSP) score	Baseline and Week 17
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) Score	Change from baseline in participant treatment satisfaction measured by the Medication Satisfaction Questionnaire (MSQ)	Baseline and Week 17

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 30, 2026
• First Submitted That Met QC Criteria: August 30, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; xanomeline; trospium chloride
• Other Study ID Numbers: ZL-2701-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No