Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

PHASE3CompletedINTERVENTIONAL
Enrollment

482

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

August 27, 2019

Study Completion Date

September 17, 2019

Conditions
Heterozygous Familial HypercholesterolemiaElevated Cholesterol
Interventions
DRUG

Inclisiran

Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

DRUG

Placebo

Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Trial Locations (45)

1035

Site 90027-009, Witbank

2193

Site 90027-010, Johannesburg

2650

Site 90045-006, Hvidovre

7130

Site 90027-004, Cape Town

Site 90027-005, Cape Town

7400

Site 90045-003, Herning

7500

Site 90027-001, Cape Town

7530

Site 90027-008, Cape Town

8907

Site 90034-006, L'Hospitalet de Llobregat

9301

Site 90027-003, Bloemfontein

14004

Site 90034-004, Córdoba

15006

Site 90034-003, A Coruña

33434

Site 90001-047, Boca Raton

43204

Site 90034-001, Reus

45227

Site 90001-002, Cincinnati

50009

Site 90034-002, Zaragoza

55102

Site 90001-056, Saint Paul

59701

Site 90001-012, Butte

89119

Site 90001-112, Las Vegas

92663

Site 90001-001, Newport Beach

92691

Site 90001-005, Mission Viejo

94305

Site 90001-015, Stanford

02114

Site 90001-004, Boston

07901

Site 90001-014, Summit

G7H 7K9

Site 90011-005, Chicoutimi

H2W 1R7

Site 90011-001, Montreal

G1V 4W2

Site 90011-002, Québec

140 21

Site 90420-001, Prague

180 00

Site 90420-006, Prague

541 01

Site 90420-005, Trutnov

DK-9000

Site 90045-001, Aalborg

DK-6700

Site 90045-004, Esbjerg

DK-4000

Site 90045-002, Roskilde

DK-8800

Site 90045-005, Viborg

3813 TZ

Site 90031-001, Amersfoort

1105 AZ

Site 90031-003, Amsterdam

1624 NP

Site 90031-009, Hoorn

5042 AD

Site 90031-006, Tilburg

3584 CX

Site 90031-005, Utrecht

0157

Site 90027-007, Pretoria

0184

Site 90027-006, Pretoria

Unknown

Site 90034-005, Barcelona

SE-41345

Site 90046-002, Gothenburg

SE-11157

Site 90046-001, Stockholm

SE-14186

Site 90046-003, Stockholm

Sponsors
All Listed Sponsors
lead

The Medicines Company

INDUSTRY