A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy

A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07021963

Enrollment

300

Registered

2025-06-15

Start date

2025-07-04

Completion date

2027-12-31

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Brief summary

This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.

Interventions

DRUGHRS-1893 Tablet

HRS-1893 tablet.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies. 2. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements. 3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.

Exclusion criteria

1. Previous history of coronary artery disease (stenosis of one or more coronary arteries \>70%) or myocardial infarction. 2. Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening. 3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening. 4. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events (AEs).	About 1 year.
Incidence of left ventricular ejection fraction (LVEF) <50%.	About 1 year.

Secondary

Measure	Time frame
The change in cardiac troponin from baseline.	Week 24 and Week 52.
The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.	Week 24 and Week 52.

Countries

China

Contacts

Primary ContactJianhong Lv

jianhong.lv.jl9@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026