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

NCT07802132 | Not Yet Recruiting FDA Drug

• 1 other identifier: ZL-2701-007
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Schizophrenia Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• KarXT Safety Profile

  through Week 17

• KarXT Treatment PatternAccording to Clinicians'Decision

  through Week 5

• KarXT Safety Profile

  through Week 17

• KarXT Treatment Effectiveness

  Week 17

• KarXT Treatment Effectiveness

  Week 17

Other Outcomes (6)

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

  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

  Baseline and Week 17

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

  Baseline and Week 17

Study Arms (1)

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)

Interventions

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.

KarXT Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Hua Shi WANG

CONTACT

+8618601287374; shihua.wang@zailaboratory.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 17 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 3, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share