CompletedPhase 2

A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

China120 participantsStarted 2025-02-18

Plain-language summary

The main purpose of this study is to evaluate the efficacy and safety of HRS-5346 in adult participants with elevated Lp(a) at high risk for cardiovascular events.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Understanding the specific procedures of the trial, voluntarily participating in this trial, and providing written informed consent;
✓. Being at least 18 years of age on the day of signing the informed consent form;
✓. Body Mass Index (BMI) within the range of 18.5 to 40 kg/m² (inclusive of boundary values);
✓. Participants must be at high risk of cardiovascular events, defined as individuals diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) and those at high risk for ASCVD.
✓. Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last administration of the study drug; female participants must have a negative blood pregnancy test and must not be breastfeeding;
✓. Willing and able to comply with all the provisions of the protocol, including demonstrating the ability to adhere to study procedures prior to random assignment.

Exclusion criteria

✕. Occurrence of any of the following events within 3 months prior to screening, or between screening and randomization, or any other event deemed by the investigator to indicate clinical instability: major cardiac or non-cardiac surgery, coronary, carotid, or peripheral artery revascularization, stroke or transient ischemic attack, myocardial infarction or unstable angina, acute limb ischemia;
✕. Planned or anticipated cardiac, cerebrovascular, or peripheral artery surgery or coronary revascularization or other major surgery after randomization;
✕. History of hemorrhagic stroke or other significant bleeding events;
✕. History of malignancy in any organ system (except well-treated basal cell carcinoma of the skin);
✕. History of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
✕. Uncontrolled type 1 or type 2 diabetes within 6 months prior to screening (including diabetic ketoacidosis or hyperosmolar hyperglycemic state or HbA1c \> 8.5% at screening);
✕. History of acute kidney injury within 12 months prior to screening;
✕. Uncontrolled hyperthyroidism or hypothyroidism;

What they're measuring

Percent Change from Baseline in Lipoprotein (a) Lp(a)

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT06816264

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-29

View on ClinicalTrials.gov More Treatment of Lipoprotein Disorder trials