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

PHASE4CompletedINTERVENTIONAL
Enrollment

1,776

Participants

Timeline

Start Date

April 8, 2022

Primary Completion Date

June 11, 2024

Study Completion Date

March 19, 2025

Conditions
Hypercholesterolemia
Interventions
DRUG

Inclisiran Sodium

Subcutaneously injected on Day 1, Day 90, and Day 270

DRUG

Placebo

Placebo to inclisiran 300 mg subcutaneously

Trial Locations (135)

1012

Novartis Investigative Site, Riga

1202

Novartis Investigative Site, Sofia

1233

Novartis Investigative Site, Sofia

1606

Novartis Investigative Site, Sofia

1618

Novartis Investigative Site, Sofia

4002

Novartis Investigative Site, Plovdiv

5000

Novartis Investigative Site, Veliko Tarnovo

5001

Novartis Investigative Site, Ogre

5300

Novartis Investigative Site, Gabrovo

5800

Novartis Investigative Site, Pleven

Novartis Investigative Site, Pleven

6000

Novartis Investigative Site, Stara Zagora

7000

Novartis Investigative Site, Rousse

8000

Novartis Investigative Site, Burgas

Novartis Investigative Site, Burgas

9010

Novartis Investigative Site, Varna

10138

Novartis Investigative Site, Tallinn

10367

Novartis Investigative Site, Berlin

10559

Novartis Investigative Site, Berlin

10787

Novartis Investigative Site, Berlin

10789

Novartis Investigative Site, Berlin

11540

Novartis Investigative Site, Sanlúcar de Barrameda

13347

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

13385

Novartis Investigative Site, Marseille

13419

Novartis Investigative Site, Tallinn

14004

Novartis Investigative Site, Córdoba

14471

Novartis Investigative Site, Potsdam

15562

Novartis Investigative Site, Rüdersdorf

16761

Novartis Investigative Site, Hennigsdorf

18057

Novartis Investigative Site, Rostock

21339

Novartis Investigative Site, Lüneburg

21423

Novartis Investigative Site, Winsen

22041

Novartis Investigative Site, Hamburg

22607

Novartis Investigative Site, Hamburg

23858

Novartis Investigative Site, Reinfeld

24105

Novartis Investigative Site, Kiel

24837

Novartis Investigative Site, Schleswig

26871

Novartis Investigative Site, Papenburg

27401

Novartis Investigative Site, Slaný

27601

Novartis Investigative Site, Mělník

28222

Novartis Investigative Site, Madrid

28277

Novartis Investigative Site, Bremen

28702

Novartis Investigative Site, San Sebastián de los Reyes

29009

Novartis Investigative Site, Málaga

30159

Novartis Investigative Site, Hanover

30449

Novartis Investigative Site, Hanover

31271

Novartis Investigative Site, Krakow

32545

Novartis Investigative Site, Bad Oeynhausen

32584

Novartis Investigative Site, Löhne

33011

Novartis Investigative Site, Oviedo

34121

Novartis Investigative Site, Kassel

36037

Novartis Investigative Site, Fulda

37075

Novartis Investigative Site, Göttingen

39110

Novartis Investigative Site, Magdeburg

39120

Novartis Investigative Site, Magdeburg

41013

Novartis Investigative Site, Seville

41014

Novartis Investigative Site, Seville

42117

Novartis Investigative Site, Wuppertal

44093

Novartis Investigative Site, Nantes

44789

Novartis Investigative Site, Bochum

45277

Novartis Investigative Site, Essen

45355

Novartis Investigative Site, Essen

45359

Novartis Investigative Site, Essen

45968

Novartis Investigative Site, Gladbeck

46063

Novartis Investigative Site, Trutnov

47051

Novartis Investigative Site, Duisburg

48149

Novartis Investigative Site, Münster

48231

Novartis Investigative Site, Warendorf

50351

Novartis Investigative Site, Chlumec nad Cidlinou

50406

Novartis Investigative Site, Tartu

51065

Novartis Investigative Site, Cologne

51069

Novartis Investigative Site, Cologne

55131

Novartis Investigative Site, Mainz

59000

Novartis Investigative Site, Lille

59300

Novartis Investigative Site, Valenciennes

60590

Novartis Investigative Site, Frankfurt am Main

60594

Novartis Investigative Site, Frankfurt am Main

61348

Novartis Investigative Site, Bad Homburg

63225

Novartis Investigative Site, Langen

63571

Novartis Investigative Site, Gelnhausen

65929

Novartis Investigative Site, Frankfurt am Main

66386

Novartis Investigative Site, Saint Ingbert Oberwuerzbach

67454

Novartis Investigative Site, Haßloch

67655

Novartis Investigative Site, Kaiserslautern

68165

Novartis Investigative Site, Mannheim

68305

Novartis Investigative Site, Mannheim

69501

Novartis Investigative Site, Hodonín

70376

Novartis Investigative Site, Stuttgart

70378

Novartis Investigative Site, Stuttgart

73011

Novartis Investigative Site, Chambéry

75013

Novartis Investigative Site, Paris

77900

Novartis Investigative Site, Olomouc

78150

Novartis Investigative Site, Le Chesnay

78224

Novartis Investigative Site, Singen

79189

Novartis Investigative Site, Bad Krozingen

80018

Novartis Investigative Site, Pärnu

80054

Novartis Investigative Site, Amiens

81377

Novartis Investigative Site, München

84453

Novartis Investigative Site, Mühldorf

90402

Novartis Investigative Site, Nuremberg

93053

Novartis Investigative Site, Regensburg

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

94574

Novartis Investigative Site, Wallerfing

96049

Novartis Investigative Site, Bamberg

96215

Novartis Investigative Site, Lichtenfels

96450

Novartis Investigative Site, Coburg

99089

Novartis Investigative Site, Erfurt

99097

Novartis Investigative Site, Erfurt

532 03

Novartis Investigative Site, Pardubice

750 02

Novartis Investigative Site, Přerov

748 01

Novartis Investigative Site, Hlučín

772 00

Novartis Investigative Site, Olomouc

01816

Novartis Investigative Site, Bad Gottleuba

01099

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

06846

Novartis Investigative Site, Dessau

01307

Novartis Investigative Site, Dresden

02977

Novartis Investigative Site, Hoyerswerda

04416

Novartis Investigative Site, Markkleeberg

01796

Novartis Investigative Site, Pirna

LV-5417

Novartis Investigative Site, Daugavpils

LV 1002

Novartis Investigative Site, Riga

LV-1001

Novartis Investigative Site, Riga

LV-1012

Novartis Investigative Site, Riga

38-400

Novartis Investigative Site, Krosno

33-100

Novartis Investigative Site, Tarnów

71-528

Novartis Investigative Site, Szczecin

81-157

Novartis Investigative Site, Gdynia

40-648

Novartis Investigative Site, Katowice

31 216

Novartis Investigative Site, Krakow

35 055

Novartis Investigative Site, Rzeszów

96 100

Novartis Investigative Site, Skierniewice

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY