Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This study is designed to evaluate the efficacy and safety of HRS-5346 Tablets in participants with high cardiovascular event risk and elevated Lp(a), and to investigate the appropriate dosage of HRS-5346 Tablets

Eligibility criteria

Qualifiers

Understand the specific procedures of the trial, voluntarily participate in this trial, and provide written informed consent;

Aged ≥ 18 years on the day of signing the informed consent form;

Body mass index (BMI) ranging from 18.5 to 40 kg/m²;

High risk of cardiovascular events at screening;

Disqualifiers

Any of the following occurring within 3 months prior to screening, or between screening and randomization: major cardiac or non-cardiac surgery, coronary, carotid or peripheral arterial revascularization, stroke or transient ischaemic attack, myocardial infarction or unstable angina, acute limb ischaemia; as well as arrhythmias requiring treatment but uncontrolled; or other events deemed clinically unstable by the Investigator;

Participants with planned or anticipated cardiac, cerebrovascular, or peripheral arterial surgery, coronary revascularization, or other major surgery during the trial period after randomization;

History of haemorrhagic stroke or other major bleeding, or occurrence of haemorrhagic stroke or other major bleeding events between screening visit and randomization visit;

Participants with an indication for anticoagulation but not receiving anticoagulant therapy at screening;

Trial design

Treatments tested in this trial

  • HRS-5346
  • HRS-5346

Treatment groups

60 Participants
are divided into 2 treatment groups