Inclisiran sodium

DRUG10 trials

Sponsors

Novartis Pharma GmbH, The Medicines Company, Novartis Pharmaceuticals, Nanjing First Hospital, Nanjing Medical University

Conditions

ASCVDAtherosclerotic Cardiovascular DiseaseCoronary Artery DiseaseElevated CholesterolHeterozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaHypercholesterolemiaRisk Factor, Cardiovascular

Phase 2

Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

CompletedNCT04666298

Novartis PharmaceuticalsHeterozygous Familial Hypercholesterolemia, Hypercholesterolemia

Start: 2021-01-29End: 2022-10-19Updated: 2024-06-20

Phase 3

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

CompletedNCT03399370

The Medicines CompanyASCVD, Elevated Cholesterol

Start: 2017-12-21End: 2019-09-17Updated: 2020-10-05

Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

CompletedNCT03400800

The Medicines CompanyASCVD, Elevated Cholesterol, Risk Factor, Cardiovascular

Start: 2017-11-01End: 2019-08-27Updated: 2020-08-21

Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

CompletedNCT03814187

Novartis PharmaceuticalsASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia +1

Start: 2019-04-16End: 2023-02-13Updated: 2024-03-06

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)

Active, not recruitingNCT04765657

Novartis PharmaceuticalsHypercholesterolemia

Start: 2021-03-01End: 2026-12-28Updated: 2025-12-30

Phase 4

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

CompletedNCT05192941

Novartis PharmaceuticalsHypercholesterolemia

Start: 2022-04-08End: 2025-03-19Updated: 2026-04-14

Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques

RecruitingNCT06338293

Nanjing First Hospital, Nanjing Medical UniversityCoronary Artery Disease

Start: 2024-03-15End: 2025-12-31Target: 40Updated: 2025-02-14

A randomized, multicenter, open-label trial comparing the effectiveness of Inclisiran to bempedoic acid on LDL cholesterol (LDL-C) lowering in participants with atherosclerotic cardiovascular disease (VICTORION-CHALLENGE)

CompletedCTIS2024-511076-32-00

Novartis Pharma GmbHHypercholesterolemia

Start: 2024-06-21End: 2026-01-02Target: 400Updated: 2025-10-10

A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.

CompletedNCT06431763

Novartis PharmaceuticalsHypercholesterolemia

Start: 2024-06-21End: 2026-01-02Updated: 2026-07-29

Unknown Phase

In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

CompletedNCT05974345

Novartis PharmaceuticalsAtherosclerotic Cardiovascular Disease

Start: 2023-11-03End: 2023-12-15Updated: 2024-05-08

Related Papers

Prediction of inclisiran efficacy in patients with established atherosclerotic cardiovascular disease: the SIRIUS In-Silico modelling of cardiovascular outcomes.

2025-12-26

Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran’s early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia

American Heart Journal2025-05-261 citations

Abstract 4134364: Predicted Low-Density Lipoprotein Cholesterol and Cardiovascular Outcomes Lowering With Inclisiran in Patients With or Without stroke: Insights from SIRIUS in silico trial.

Circulation2024-11-12

Abstract 4139801: Predicted efficacy of Inclisiran compared to active comparators on Cardiovascular Outcomes in patients with established atherosclerotic cardiovascular disease: results from the In Silico SIRIUS trial

Circulation2024-11-12

Abstract 4139141: Predicted efficacy of inclisiran on cardiovascular outcomes in lower extremity peripheral artery disease: results of the In Silico Sirius study

Circulation2024-11-111 citations

In-silico trial emulation to predict the cardiovascular protection of new lipid-lowering drugs: an illustration through the design of the SIRIUS programme

European Journal of Preventive Cardiology2024-08-0510 citations

Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease

Mayo Clinic Proceedings2024-08-0114 citations

Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial

Cardiovascular Research2024-05-1565 citations

A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients.

2023-12-194 citations

Efficacy and Safety of Inclisiran in Asian Patients

JACC Asia2023-11-1421 citations

Plain Language Summary of Results From ORION-10 and ORION-11: Two Studies to Learn How Well Inclisiran Works in People with High Cholesterol

Future Cardiology2023-03-012 citations

EFFICACY AND SAFETY OF INCLISIRAN BY BASELINE BODY MASS INDEX: A POST HOC POOLED ANALYSIS OF THE ORION-9, ORION-10 AND ORION-11 PHASE III RANDOMIZED CONTROLLED TRIALS

American Journal of Preventive Cardiology2023-01-211 citations

Abstract 11143: Efficacy and Safety of Inclisiran by Baseline Body Mass Index: A Post Hoc Pooled Analysis of the ORION-9, ORION-10 and ORION-11 Phase III Randomized Controlled Trials

Circulation2021-11-16

Efficacy and safety of inclisiran in patients with established cerebrovascular disease: pooled, post hoc analysis of the ORION-9, ORION-10 and ORION-11, phase 3 randomised clinical trials

European Heart Journal2021-10-013 citations

Efficacy and safety of inclisiran in patients with polyvascular disease: pooled, post hoc analysis of the ORION-9, ORION-10 and ORION-11, phase 3 randomised controlled trials

European Heart Journal2021-10-012 citations

Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol

New England Journal of Medicine2020-03-181444 citations