A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
Inclusion Criteria:
Exclusion Criteria:
New York Heart Association (NYHA) class IV heart failure.
Uncontrolled cardiac arrhythmia
Uncontrolled severe hypertension
Active liver disease
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.