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Clinical Trials in China / NCT04765657
Active, not recruiting Phase 3

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)

NCT04765657 · tracked via the Priya Life Science China tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2021-03-01
Last updated
2025-12-30

Condition(s) studied

Hypercholesterolemia

Investigational drug(s) / intervention(s)

inclisiran sodiumPlacebo

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: -At screening participants with: ASCVD (including acute coronary syndrome (ACS), stable coronary heart disease, post revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack (TIA), and peripheral atherosclerosis) and Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) OR ASCVD high risk (LDL-C ≥4.9 mmol/L, diabetes, high 10-year ASCVD risk assessed by Chinese ASCVD Risk Assessment Flow Chart , or high risk per local guidelines with a target LDL-C of \<100 mg/dL) and Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) * Fasting triglyceride \< 400 mg/dL (\< 4.52 mmol/L) at screening. * Participants on statins should be receiving a maximally tolerated dose . Maximum tolerated dose is defined as the maximum dose of statin that can be taken on a regular basis without intolerable AE. Intolerance to any dose of statin must be documented as historical AEs attributed to the statin in question on the source documentation and on the Medical history page of the eCRF * Participants not receiving statin must have a documented evidence of intolerance to all doses of at least 2 different statins(or the corresponding local definition of complete intolerance to statins) * Participants following lifestyle modification should be on the therapy of LDL-C lowering (such as statin monotherapy, or statin incombination with ezetimibe) with a stable dose for ≥30 days before screening and have no planned medication or dose change during study participation. * Participants are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures. Exclusion Criteria: * New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%. * Cardiac arrhythmia with clinical significance within 3 months prior to randomization that is not controlled by medication or via ablation. * Major adverse cardiovascular event within 3 months prior to randomization. * Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg prior to randomization despite antihypertensive therapy. * Calculated glomerular filtration rate ≤30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology. * Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years. * History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization. * Barrier method: Condom or Occlusive cap (e.g. diaphragm or cervical/vault caps). * Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
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 China

Other trials for the same condition

Official registry record

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 China