A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C
The purpose of the study is to demonstrate the efficacy and safety of inclisiran sodium 300mg to support the indication for LDL-C reduction of inclisiran in Asian patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-high risk patients with elevated LDL-C as an adjunct to diet and maximally tolerated dose statins with or without additional lipid-lowering therapy. A core part (2-week screening period and a 12-month double-blinded treatment period), and an extension part (until reasonable access to the IMP post product launch provided for the participants)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
345
Subcutaneously injected on Day 1, 90 and 270 (Core Part). Subcutaneously injected on Day 360 and every 6 months thereafter until EOS visit (Extension Part)
Subcutaneously injected on Day 1, 90, and 270.
Core: Percentage change in low- density lipoprotein cholesterol (LDL-C)
Superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330
Time frame: Baseline, Day 330
Extension: Number of participants with Adverse Events
Evaluation of the safety and tolerability of inclisiran, treatment emergent Adverse events and Serious Adverse Events
Time frame: Day 360 until study completion, an average of 3 years
Core: Time adjusted percentage change in LDL-C
The superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 and over time
Time frame: From baseline after Day 90 and up to Day 360
Core: Absolute change in LDL-C
The superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 and over time
Time frame: From baseline to Day 330
Core: Time adjusted absolute change in LDL-C
The superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 and over time
Time frame: From baseline after Day 90 and up to Day 360
Core: Percentage change in PCSK9
The superiority of inclisiran compared to placebo in reducing PCSK9 from baseline to Day 330
Time frame: From baseline to Day 330
Core: Absolute change in PCSK9
The superiority of inclisiran compared to placebo in reducing PCSK9 from baseline to Day 330
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Novartis Investigative Site
Lanzhou, Gansu, China
Novartis Investigative Site
Foshan, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Baotou, Inner Mongolia, China
Novartis Investigative Site
Hohhot, Inner Mongolia, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nantong, Jiangsu, China
Novartis Investigative Site
Suzhou, Jiangsu, China
...and 35 more locations
Time frame: From baseline to Day 330
Core: Proportion of participants reaching LDL-C levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL
The superiority of inclisiran compared to placebo in individual response rate for lipid controlling
Time frame: Day 330
Core: Proportion of participants in each group with ≥ 50% LDL-C reduction
The superiority of inclisiran compared to placebo in individual response rate for lipid controlling
Time frame: From baseline to Day 330
Core: Proportion of participants in each group who attain global lipid targets for their level of ASCVD risk (55mg/dl for ASCVD patients, 70mg/dl for ASCVD high risk patients)
The superiority of inclisiran compared to placebo in individual response rate for lipid controlling
Time frame: Day 330
Core: Percentage change in total cholesterol, ApoB, non-HDL-C, ApoA1, HDL-C, Lp(a) and triglycerides
The superiority of inclisiran compared to placebo in reducing other lipids, lipoproteins and apolipoproteins
Time frame: From baseline to Day 330
Core: Absolute change in total cholesterol, ApoB, non-HDL-C, ApoA1, HDL-C, Lp(a) and triglycerides
The superiority of inclisiran compared to placebo in reducing other lipids, lipoproteins and apolipoproteins
Time frame: From baseline to Day 330