A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy

Phase 2

Recruiting

• Conditions: Non-obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893 placebo; Drug: HRS-1893

• Registration Number: NCT06816251
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Study Start: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Age 18~85 years old (including boundary value), male or female.
2. Body mass index < 35 kg/m2.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
4. Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
5. 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 of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.

Exclusion Criteria

1. Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
2. Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
5. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-1893 placebo low-dose group	HRS-1893 placebo	-
HRS-1893 high-dose group	HRS-1893	-
HRS-1893 placebo high-dose group	HRS-1893 placebo	-
HRS-1893 low-dose group	HRS-1893	-

Primary Outcome Measures

Name	Time	Method
The incidence of left ventricular ejection fraction (LVEF) < 50%	Up to 14 weeks.
Adverse events (AEs)	Up to 14 weeks.

Secondary Outcome Measures

Name	Time	Method
Peak oxygen uptake (pVO2) value	About 12 weeks.
The cardiac troponin value	About 12 weeks.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China