Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Athersclerotic Cardiovascular Disease(ascvd) With Elevated Ldl Cholesterol Levels,covid-19
• Age: Between 40 years - 85 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Established cardiovascular (CV) disease.
  3. At the Screening Visit, participants must be on a stable (=4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without ezetimibe) that must include a high-intensity statin therapy with either atorvastatin =40 mg QD or rosuvastatin =20 mg QD.
  4. Fasting LDL-C =1.8 mmol/L (70 mg/dL) at the Screening Visit, measured at the central laboratory.

  
  

You may not be eligible for this study if the following are true:

• 1. Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease <4 weeks prior to the first study visit (defined as either the Statin Optimization Screening Visit or the Screening Visit, whichever comes first) or during the Statin Optimization or Screening periods.
  2. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary re-vascularization within the 6 months after the first study visit.
  3. Heart failure NYHA class III or IV at the Statin Optimization Screening Visit (if applicable), the Screening Visit, or at the Baseline Visit (Day 1).
  4. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Statin Optimization Screening Visit (if applicable) or Screening Visit.
  5. Previous (within 90 days prior to the first study visit i.e. the Statin Optimization Screening Visit or the Screening Visit) treatment with a mAb directed towards PCSK9 (e.g., evolocumab, alirocumab) or planned use post first study visit.
  6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years prior to the first study visit (Statin Optimization Screening Visit or the Screening Visit, whichever comes first).
  7. History of hypersensitivity to the study drug or its excipients or to other siRNA drugs.
  8. Use of other investigational drugs within 5 half-lives, 30 days or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer, or longer if required by local regulation, prior to the first study visit (Statin Optimization Screening Visit or the Screening Visit, whichever comes first).
  9. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years.
  10. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 3 years prior to the first study visit (defined as either the Statin Optimization Screening Visit or the Screening Visit, whichever comes first).
  11. Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits, fasting blood draws and compliance with study treatment regimens), and medication administration (injections) and schedule.
  12. Pregnant or nursing (lactating) women.
  13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.