Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Condition(s) studied
Investigational drug(s) / intervention(s)
inclisiran sodium: 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)
Placebo: Subcutaneously injected on Day 1, 90, and 270.
Study summary
A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C
Eligibility
Primary outcome measure(s)
- Core: Percentage change in low- density lipoprotein cholesterol (LDL-C) — Baseline, Day 330
Superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 - Extension: Number of participants with Adverse Events — Day 360 until study completion, an average of 3 years
Evaluation of the safety and tolerability of inclisiran, treatment emergent Adverse events and Serious Adverse Events
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Lanzhou | Gansu | |
| Novartis Investigative Site | Foshan | Guangdong | |
| Novartis Investigative Site | Guangzhou | Guangdong | |
| Novartis Investigative Site | Shijiazhuang | Hebei | |
| Novartis Investigative Site | Baotou | Inner Mongolia | |
| Novartis Investigative Site | Hohhot | Inner Mongolia | |
| Novartis Investigative Site | Nanjing | Jiangsu | |
| Novartis Investigative Site | Nanjing | Jiangsu | |
| Novartis Investigative Site | Nantong | Jiangsu | |
| Novartis Investigative Site | Suzhou | Jiangsu | |
| Novartis Investigative Site | Xuzhou | Jiangsu | |
| Novartis Investigative Site | Changchun | Jilin | |
| Novartis Investigative Site | Changchun | Jilin | |
| Novartis Investigative Site | Jinan | Shandong | |
| Novartis Investigative Site | Jinshan | Shanghai Municipality | |
| Novartis Investigative Site | Taiyuan | Shanxi | |
| Novartis Investigative Site | Xian | Shanxi | |
| Novartis Investigative Site | Tianjin | Tianjin Municipality | |
| Novartis Investigative Site | Hangzhou | Zhejiang | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Shanghai | China | |
| Novartis Investigative Site | Shanghai | China | |
| Novartis Investigative Site | Shanghai | China | |
| Novartis Investigative Site | Shanghai | China | |
| Novartis Investigative Site | Tianjin | China | |
| Novartis Investigative Site | Tianjin | China | |
| Novartis Investigative Site | Xiamen | China | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Wŏnju | Gangwon-do | |
| Novartis Investigative Site | Incheon | Korea | |
| Novartis Investigative Site | Seoul | Korea | |
| Novartis Investigative Site | Seoul | Korea | |
| Novartis Investigative Site | Seoul | Seoul | |
| Novartis Investigative Site | Seoul | South Korea | |
| Novartis Investigative Site | Gwangju | South Korea | |
| Novartis Investigative Site | Seoul | South Korea |
+ 5 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04765657 on ClinicalTrials.gov ↗ ← All trials in South Korea