A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovas… (NCT07185776) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
China203 participantsStarted 2025-10-21
Plain-language summary
The main purpose of this study is to evaluate the efficacy and safety of HRS-5632 in adult participants with elevated Lipoprotein(a) (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 moderate risk or high risk for ASCVD；
✓. Based on clinical practice, participants receiving the following medications must be receiving a stable regimen prior to screening or randomization and expected to remain on a stable regimen at the end of the treatment follow-up period:
✓. Lipid-lowering drugs (statins, cholesterol absorption inhibitors, prescription-dose niacin, fibrates, fish oil or other omega-3 fatty acid-containing products, including over-the-counter \[OTC\] preparations) must be receiving a stable regimen for ≥ 8 weeks prior to randomization; PCSK9 monoclonal antibodies must be receiving a stable regimen for ≥ 12 weeks prior to screening;
✓. Testosterone, estrogen, anti-estrogen/anti-androgen, progestin, selective estrogen receptor modulator, or growth hormone must be receiving a stable regimen for ≥ 4 weeks prior to screening;
✓. Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 1 year after the last administration of the study drug; female participants must have a negative blood pregnancy test and must not be breastfeeding;
Exclusion criteria
What they're measuring
1
The percent change from the baseline in Lipoprotein (a) (Lp(a)).
✕. Any of the following events occurring within 3 months prior to screening or between screening and randomization, or other events considered by the investigator to indicate clinical instability: major cardiac or non-cardiac surgery; coronary, carotid, or peripheral arterial revascularization; stroke or transient ischemic attack, myocardial infarction or unstable angina, acute limb ischemia, and uncontrolled arrhythmias requiring treatment;
✕. Cardiac, cerebrovascular, or peripheral arterial surgery or coronary revascularization planned or anticipated during the trial after randomization;
✕. A history of hemorrhagic stroke or other major bleeding (e.g., hemophilia, von Willebrand disease, coagulation factor deficiency), or a hemorrhagic stroke or other major bleeding event (fatal; major organ bleeding; resulting in a rapid, short-term decrease in hemoglobin or blood transfusion) occurring between the screening visit and the randomization visit;
✕. Patients with an indication for anticoagulation at screening but not receiving anticoagulation therapy, such as patients with atrial fibrillation or flutter or those undergoing aortic valve replacement;
✕. History of any organ system malignancy within 5 years prior to screening (excluding cured basal cell or squamous cell skin cancer, non-invasive stage 0 cervical cancer, non-invasive stage 0 prostate cancer, or ductal carcinoma in situ of the breast), or a history of any organ system malignancy diagnosed between the screening visit and the randomization visit, regardless of whether there is evidence of local recurrence or metastasis;
✕. A history of a disease that significantly affects lipid levels, such as nephrotic syndrome, severe liver disease, or Cushing's syndrome;
✕. Uncontrolled type 1 or type 2 diabetes (including diabetic ketoacidosis or hyperglycemic hyperosmolar state) within 6 months prior to screening, or HbA1c \> 8.0% at screening (secondary confirmation is permitted);
✕. History of acute kidney injury within 12 months prior to screening;