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)

NCT ID: NCT04765657

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2026-12-28

Brief Summary

A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C

Detailed Description

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)

Conditions

Hypercholesterolemia

Keywords

inclisiran; siRNA; dyslipidemia; KJX839

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

inclisiran sodium 300 mg

Subcutaneous injection

Group Type: EXPERIMENTAL

inclisiran sodium

Intervention Type: DRUG

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

Subcutaneous injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneously injected on Day 1, 90, and 270.

Interventions

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)

Intervention Type: DRUG

Placebo

Subcutaneously injected on Day 1, 90, and 270.

Intervention Type: DRUG

Other Intervention Names

KJX839

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Novartis Investigative Site

Xuzhou, Jiangsu, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Jinan, Shandong, China

Novartis Investigative Site

Zhujing, Shanghai Municipality, China

Novartis Investigative Site

Taiyuan, Shanxi, China

Novartis Investigative Site

Xian, Shanxi, China

Novartis Investigative Site

Tianjin, Tianjin Municipality, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

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, South Korea

Novartis Investigative Site

Incheon, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea, South Korea

Novartis Investigative Site

Gwangju, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Kaohsiung City, , Taiwan

Novartis Investigative Site

Taipei, , Taiwan

Novartis Investigative Site

Taipei, , Taiwan

Novartis Investigative Site

Taipei, , Taiwan

Countries

China; Singapore; South Korea; Taiwan

References

Huo Y, Lesogor A, Lee CW, Chiang CE, Mena-Madrazo J, Poh KK, Jeong MH, Maheux P, Zhang M, Wei S, Han Y, Li Y. Efficacy and Safety of Inclisiran in Asian Patients: Results From ORION-18. JACC Asia. 2023 Nov 14;4(2):123-134. doi: 10.1016/j.jacasi.2023.09.006. eCollection 2024 Feb.

Reference Type: DERIVED

PMID: 38371290 (View on PubMed)

Other Identifiers

CKJX839A12307

Identifier Type: -

Identifier Source: org_study_id