NCT05763875 - Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. | Biotech Hunter

Enrollment

350

Participants

Timeline

Start Date

March 15, 2023

Primary Completion Date

June 20, 2024

Study Completion Date

June 20, 2024

Conditions

Hypercholesterolemia

Interventions

DRUG

Inclisiran

284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90

DRUG

Ezetimibe

10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149

DRUG

Matching Placebo for Inclisiran

0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90

DRUG

Matching Placebo for Ezetimibe

0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149

Trial Locations (42)

1083

Novartis Investigative Site, Budapest

7623

Novartis Investigative Site, Pécs

10456

Prime Global Research Inc, The Bronx

10787

Novartis Investigative Site, Berlin

22607

Novartis Investigative Site, Hamburg

23219

Dominion Medical Associates, Richmond

26871

Novartis Investigative Site, Papenburg

28112

Monroe Biomedical Research, Monroe

30449

Novartis Investigative Site, Hanover

32584

Novartis Investigative Site, Löhne

32720

Hillcrest Medical Research, DeLand

32751

ClinCloud, Maitland

33014

Inpatient Research Clinical LLC, Miami Lakes

33162

Harmony Clinical Research, North Miami Beach

33165

Alma Clinical Research Inc, Miami

33541

Cozy Research LLC, Zephyrhills

33563

Fam Medical Specialists Of Fl Plc, Plant City

35215

Parkway Medical Center, Birmingham

36305

SEC Clinical Research, Dothan

37203

Compass Point Research, Nashville

39319

Novartis Investigative Site, Jerichow

44789

Novartis Investigative Site, Bochum

45424

WellNow Urgent Care and Research, Huber Heights

45968

Novartis Investigative Site, Gladbeck

53095

Spaulding Clinical Research, West Bend

58103

Lillestol Research LLC, Fargo

61550

Koch Family Medicine, Morton

64060

Novartis Investigative Site, Monterrey

64440

Novartis Investigative Site, Monterrey

70791

Southern Clin Research Clinic, Zachary

71101

Grace Research Llc, Shreveport

71111

Grace Research LLC, Bossier City

73013

Conrad Clinical Research, Edmond

76000

Novartis Investigative Site, Querétaro

77479

Mt Olympus Medical Research, Sugar Land

80230

Novartis Investigative Site, Culiacan Sinaloa

80809

Novartis Investigative Site, Munich

97070

Novartis Investigative Site, Mérida

170008

Novartis Investigative Site, Manizales

684031

Novartis Investigative Site, San Gil

080012

Novartis Investigative Site, Barranquilla

57-7

Novartis Investigative Site, Floridablanca