Primary Hypercholesterolemia or Mixed Dyslipidemia Clinical Trial
Official title:
A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol
The purpose of this study is to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who are not on any lipid lowering therapy.
This study is designed as a randomized, double-blind, multi-center phase 3 trial, with a placebo-controlled period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300mg s.c. in participants aged 18~75 years with low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but < 190 mg/dL who are not on any lipid lowering therapy. ;