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NCT Number: NCT06816251

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100032, China

Location status: Recruiting

Location contact

Lianming Kang

CONTACT

[email protected]

010-88396870

Lianming Kang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18~85 years old (including boundary value), male or female.
  • Body mass index < 35 kg/m2.
  • Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
  • 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.
  • 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

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

Treatment and study plan

HRS-1893

Drug

HRS-1893 tablet.

HRS-1893 placebo

Drug

HRS-1893 tablet placebo.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Up to 14 weeks.

  2. The incidence of left ventricular ejection fraction (LVEF) < 50%

    Time frame: Up to 14 weeks.

Secondary outcomes

  1. Peak oxygen uptake (pVO2) value

    Time frame: About 12 weeks.

  2. The cardiac troponin value

    Time frame: About 12 weeks.

Study contacts

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

Jianhong Lv

CONTACT

[email protected]

18921102884

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Mar 5, 2025

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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