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

An Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C

ClinicalTrials.gov Identifier: NCT03814187

Novartis Reference Number: MDCO-PCS-17-05

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this extension study is to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study will be a global multicenter study.

Condition 
ASCVD
Elevated Cholesterol
Heterozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
2991 participants
Start date 
Apr 16, 2019
Completion date 
Dec 01, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

Completion of a previously qualifying Phase III lipid-lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10), MDCO-PCS-17-08 (ORION-11) or MDCO-PCS-17-02 (ORION-5)] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation.
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:

Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk [according to investigator's (or delegate's) judgment] if he/she participates in the clinical study.
An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years,
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation >3x the upper limit of normal (ULN), or total bilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder study prior to study entry visit.

Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one method of acceptable effective contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion:

Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
Women who are surgically sterilized at least 3 months prior to enrollment.
Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study.

Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:

Subjects who are unable to communicate or to cooperate with the investigator
Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study)
Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study
Persons directly involved in the conduct of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Locations

United States
Research Site 10001-015
-
Birmingham, 35211
Alabama
United States
Research Site 10001-138
-
Foley, 36535
Alabama
United States
Research Site 10001-113
-
Huntsville, 35801
Alabama
United States
Research Site 10001-058
-
Mobile, 36608
Alabama
United States
Research Site 10001-037
-
Montgomery, 36117
Alabama
United States
Research Site 10001-076
-
Saraland, 36571
Alabama
United States
Research Site 10001-013
-
Chandler, 85224
Arizona
United States
Research Site 10001-077
-
Mesa, 85213
Arizona
United States
Research Site 10001-136
-
Phoenix, 85014
Arizona
United States
Research Site 10001-051
-
Surprise, 85374
Arizona
United States
Research Site 10001-019
-
Tucson, 85712
Arizona
United States
Research Site 10001-004
-
Tucson, 85741
Arizona
United States
Research Site 10001-132
-
Tucson, 85745
Arizona
United States
Research Site 10001-073
-
Beverly Hills, 90211
California
United States
Research Site 10001-050
-
Canoga Park, 91303
California
United States
Research Site 10001-011
-
Carlsbad, 92008
California
United States
Research Site 10001-065
-
El Cajon, 92020
California
United States
Research Site 10001-150
-
Los Angeles, 90022
California
United States
Research Site 90001-005
-
Mission Viejo, 92691
California
United States
Research Site 10001-043
-
Northridge, 91324
California
United States
Research Site 10001-022
-
Northridge, 91325
California
United States
Research Site 10001-033
-
Sacramento, 95821-2134
California
United States
Research Site 10001-105
-
San Ramon, 94582
California
United States
Research Site 10001-008
-
Santa Rosa, 95405
California
United States
Research Site 10001-153
-
Spring Valley, 91978
California
United States
Research Site 90001-015
-
Stanford, 94305
California
United States
Research Site 10001-044
-
Torrance, 90502
California
United States
Research Site 90001-047
-
Boca Raton, 33434
Florida
United States
Research Site 10001-084
-
Clearwater, 33756
Florida
United States
Research Site 10001-155
-
Clearwater, 33756
Florida
United States
Research Site 10001-099
-
Clearwater, 33761
Florida
United States
Research Site 10001-127
-
Daytona Beach, 32117
Florida
United States
Research Site 10001-119
-
Fleming Island, 32003
Florida
United States
Research Site 10001-070
-
Fort Lauderdale, 33308
Florida
United States
Research Site 10001-067
-
Hialeah, 33012
Florida
United States
Research Site 10001-139
-
Jacksonville, 32204
Florida
United States
Research Site 10001-039
-
Jacksonville, 32216
Florida
United States
Research Site 10001-098
-
Jacksonville, 32216
Florida
United States
Research Site 10001-080
-
Miami Springs, 33166
Florida
United States
Research Site 10001-081
-
Miami, 33126
Florida
United States
Research Site 10001-140
-
Miami, 33126
Florida
United States
Research Site 10001-142
-
Miami, 33126
Florida
United States
Research Site 10001-030
-
Miami, 33165
Florida
United States
Research Site 10001-116
-
Miami, 33183
Florida
United States
Research Site 10001-027
-
Pembroke Pines, 33024
Florida
United States
Research Site 10001-115
-
Pembroke Pines, 33027
Florida
United States
Research Site 10001-048
-
Pembroke Pines, 33029
Florida
United States
Research Site 10001-147
-
Pembroke Pines, 33029
Florida
United States
Research Site 10001-003
-
Pinellas Park, 33781
Florida
United States
Research Site 10001-104
-
Ponte Vedra, 32081
Florida
United States
Research Site 10001-090
-
Saint Augustine, 32086
Florida
United States
Research Site 10001-102
-
Saint Petersburg, 33713
Florida
United States
Research Site 10001-123
-
Sarasota, 34239-3513
Florida
United States
Research Site 10001-143
-
Tampa, 33614
Florida
United States
Research Site 10001-069
-
Atlanta, 30342
Georgia
United States
Research Site 10001-137
-
Dunwoody, 30338
Georgia
United States
Research Site 10001-092
-
Macon, 31210
Georgia
United States
Research Site 10001-059
-
Arlington Heights, 60005
Illinois
United States
Research Site 10001-158
-
Chicago, 60652
Illinois
United States
Research Site 10001-036
-
Evanston, 60201
Illinois
United States
Research Site 10001-082
-
Indianapolis, 46260
Indiana
United States
Research Site 10001-040
-
Valparaiso, 46383
Indiana
United States
Research Site 10001-074
-
West Des Moines, 50266
Iowa
United States
Research Site 10001-028
-
Hutchinson, 67502
Kansas
United States
Research Site 10001-125
-
Lexington, 40503
Kentucky
United States
Research Site 10001-108
-
Lexington, 40504
Kentucky
United States
Research Site 10001-107
-
Owensboro, 42303
Kentucky
United States
Research Site 10001-144
-
Crowley, 70526
Louisiana
United States
Research Site 10001-041
-
Lake Charles, 70601
Louisiana
United States
Research Site 10001-101
-
Monroe, 71201
Louisiana
United States
Research Site 90001-004
-
Boston, 02114
Massachusetts
United States
Research Site 10001-024
-
Flint, 48504
Michigan
United States
Research Site 10001-095
-
Grandville, 49418
Michigan
United States
Research Site 10001-078
-
Sterling Heights, 48310
Michigan
United States
Research Site 10001-034
-
Troy, 48098
Michigan
United States
Research Site 10001-018
-
Edina, 55435
Minnesota
United States
Research Site 90001-056
-
Saint Paul, 55102
Minnesota
United States
Research Site 10001-156
-
Saint Louis, 63136
Missouri
United States
Research Site 10001-007
-
Saint Louis, 63141
Missouri
United States
Research Site 90001-012
-
Butte, 59701
Montana
United States
Research Site 10001-053
-
Omaha, 68134
Nebraska
United States
Research Site 10001-021
-
Omaha, 68144
Nebraska
United States
Research Site 90001-112
-
Las Vegas, 89119
Nevada
United States
Research Site 10001-124
-
Las Vegas, 89121
Nevada
United States
Research Site 10001-060
-
Bridgewater, 08807
New Jersey
United States
Research Site 90001-014
-
Summit, 07901
New Jersey
United States
Research Site 10001-055
-
Warren, 07059
New Jersey
United States
Research Site 10001-054
-
Albany, 12206
New York
United States
Research Site 10001-122
-
Binghamton, 13901
New York
United States
Research Site 10001-128
-
Endwell, 13760
New York
United States
Research Site 10001-042
-
New Windsor, 12553
New York
United States
Research Site 10001-129
-
Poughkeepsie, 12601
New York
United States
Research Site 10001-110
-
Williamsville, 14221
New York
United States
Research Site 10001-063
-
Cary, 27518
North Carolina
United States
Research Site 10001-064
-
Greensboro, 27401
North Carolina
United States
Research Site 10001-145
-
Mooresville, 28117
North Carolina
United States
Research Site 10001-046
-
Shelby, 28150
North Carolina
United States
Research Site 10001-016
-
Akron, 443311
Ohio
United States
Research Site 10001-120
-
Cincinnati, 45219
Ohio
United States
Research Site 90001-002
-
Cincinnati, 45227
Ohio
United States
Research Site 10001-010
-
Cincinnati, 45236
Ohio
United States
Research Site 10001-134
-
Cincinnati, 45246
Ohio
United States
Research Site 10001-014
-
Columbus, 43212
Ohio
United States
Research Site 10001-141
-
Dayton, 45419
Ohio
United States
Research Site 10001-148
-
Marion, 43302
Ohio
United States
Research Site 10001-109
-
Wyomissing, 19610
Pennsylvania
United States
Research Site 10001-001
-
Anderson, 29621
South Carolina
United States
Research Site 10001-006
-
Greer, 29651
South Carolina
United States
Research Site 10001-075.
-
Greer, 29651
South Carolina
United States
Research Site 10001-111
-
Myrtle Beach, 29588
South Carolina
United States
Research Site 10001-133
-
Pelzer, 29669
South Carolina
United States
Research Site 10001-103
-
Rapid City, 57701
South Dakota
United States
Research Site 10001-146
-
Athens, 37303
Tennessee
United States
Research Site 10001-130
-
Kingsport, 37660
Tennessee
United States
Research Site 10001-118
-
Knoxville, 37909
Tennessee
United States
Research Site 10001-106
-
Knoxville, 37917
Tennessee
United States
Research Site 10001-100
-
Amarillo, 79106
Texas
United States
Research Site 10001-087
-
Austin, 78726
Texas
United States
Research Site 10001-117
-
Austin, 78756
Texas
United States
Research Site 10001-009
-
Dallas, 75234
Texas
United States
Research Site 10001-068
-
Edinburg, 78503
Texas
United States
Research Site 10001-031
-
Houston, 77002
Texas
United States
Research Site 10001-088
-
Houston, 77024
Texas
United States
Research Site 10001-091
-
Houston, 77027
Texas
United States
Research Site 10001-061
-
Houston, 77058
Texas
United States
Research Site 10001-032
-
Houston, 77070
Texas
United States
Research Site 10001-057
-
New Braunfels, 78130
Texas
United States
Research Site 10001-079
-
Round Rock, 78681
Texas
United States
Research Site 10001-071
-
San Antonio, 78229
Texas
United States
Research Site 10001-083
-
Schertz, 78154
Texas
United States
Research Site 10001-149
-
Shavano Park, 78231
Texas
United States
Research Site 10001-045
-
Tomball, 77375
Texas
United States
Research Site 10001-005
-
Layton, 84041
Utah
United States
Research Site 10001-002
-
Salt Lake City, 84123
Utah
United States
Research Site 10001-052
-
Salt Lake City, 94107
Utah
United States
Research Site 10001-093
-
Falls Church, 22042
Virginia
United States
Research Site 10001-085
-
Manassas, 20110
Virginia
United States
Research Site 10001-094
-
Midlothian, 23114
Virginia
United States
Research Site 10001-023
-
Richmond, 23294
Virginia
United States
Research Site 10001-029
-
Suffolk, 23435
Virginia
United States
Research Site 10001-114
-
Tacoma, 98405
Washington
United States
Canada
Research Site 90011-005
-
Chicoutimi, G7H 7K9
Quebec
Canada
Research Site 90011-001
-
Montréal, H2W 1R7
Quebec
Canada
Research Site 90011-002
-
Québec, GIV 4W2
Quebec
Canada
Czechia
Research Site 11420-002
-
Chomutov, 430 02
-
Czechia
Research Site 90420-001
-
Praha, 140 21
-
Czechia
Research Site 90420-006
-
Praha, 180 81
-
Czechia
Research Site 11420-003
-
Uherské Hradiště, 686 01
-
Czechia
Denmark
Research Site 90045-001
-
Aalborg, 9000
Nordjylland
Denmark
Research Site 90045-004
-
Esbjerg, 6700
-
Denmark
Research Site 90045-003
-
Herning, 7400
-
Denmark
Research Site 90045-006
-
Hvidovre, 2650
-
Denmark
Research Site 90045-002
-
Roskilde, 4000
-
Denmark
Research Site 90045-005
-
Viborg, 8800
-
Denmark
Germany
Research Site 11049-006
-
Berlin, 12627
-
Germany
Research Site 11049-002
-
Bochum, 47787
-
Germany
Research Site 11049-003
-
Frankfurt, 60313
-
Germany
Research Site 11049-001
-
Heidelberg, 69120
-
Germany
Research Site 11049-007
-
Heidelberg, 69120
-
Germany
Hungary
Research Site 11036-001
-
Budapest,
-
Hungary
Research Site 11036-004
-
Debrecen,
-
Hungary
Research Site 11036-002
-
Hatvan,
-
Hungary
Research Site 11036-003
-
Zalaegerszeg,
-
Hungary
Netherlands
Research Site 90031-001
-
Amersfoort, 3813 TZ
-
Netherlands
Research Site 90031-003
-
Amsterdam, 1105 AZ
-
Netherlands
Research Site 90031-006
-
Goes, 4462 RA
-
Netherlands
Research Site 90031-009
-
Hoorn, 1624 NP
-
Netherlands
Research Site 90031-005
-
Utrecht,
-
Netherlands
Poland
Research SIte 11048-016
-
Brzozowie,
-
Poland
Research Site 11048-018
-
Bydgoszcz, 85-079
-
Poland
Research Site 11048-011
-
Bydgoszcz,
-
Poland
Research Site 11048-004
-
Gdańsk,
-
Poland
Research Site 11048-005
-
Gdynia,
-
Poland
Research Site 11048-007
-
Katowice,
-
Poland
Research SIte 11048-012
-
Katowice,
-
Poland
Research Site 11048-003
-
Kraków,
-
Poland
Research SIte 11048-014
-
Kraków,
-
Poland
Research Site 11048-008
-
Lublin,
-
Poland
Research Site 11048-001
-
Poznań,
-
Poland
Research Site 11048-019
-
Ruda Śląska, 41-709
-
Poland
Research SIte 11048-013
-
Rzeszów,
-
Poland
Research SIte 11048-015
-
Tarnów,
-
Poland
Research Site 11048-006
-
Warsaw,
-
Poland
Research Site 11048-009
-
Warsaw,
-
Poland
Research Site 11048-002
-
Wrocław,
-
Poland
Research Site 11048-010
-
Wrocław,
-
Poland
South Africa
Research Site 90027-008
-
Bellville, 7530
Cape Town
South Africa
Research Site 90027-007
-
Lyttelton, 0157
Cape Town
South Africa
Research Site 90027-003
-
Bloemfontein, 9301
Free State
South Africa
Research Site 90027-010
-
Johannesburg, 2193
Gauteng
South Africa
Research Site 11027-005
-
Kempton Park, 1619
Gauteng
South Africa
Research Site 90027-006
-
Pretoria, 0184
Gauteng
South Africa
Research Site 90027-009
-
Witbank, 1035
Gauteng
South Africa
Research Site 90027-001
-
Cape Town, 7500
Western Cape
South Africa
Research Site 11027-007
-
Kuilsrivier, 7580
Western Cape
South Africa
Research Site 11027-013
-
Paarl, 7646
Western Cape
South Africa
Research Site 90027-004
-
Somerset West, 7130
Western Cape
South Africa
Research Site 90027-005
-
Somerset West, 7130
Western Cape
South Africa
Spain
Research Site 90034-004
-
Córdoba, 14004
Andalucia
Spain
Research Site 90034-002
-
Zaragoza, 5009
Aragon
Spain
Research Site 90034-005
-
Barcelona, 08036
Cataluna
Spain
Research Site 90034-006
-
Barcelona, 08907
Cataluna
Spain
Research Site 90034-001
-
Reus, 43204
Cataluna
Spain
Research Site 90034-003
-
La Coruña, 15002
Galicia
Spain
Sweden
Research Site 90046-002
-
Göteborg, SE-41346
-
Sweden
Research Site 90046-001
-
Stockholm, SE-11446
-
Sweden
Research Site 90046-003
-
Stockholm, SE-14186
-
Sweden
Ukraine
Research Site 11380-005
-
Cherkasy,
-
Ukraine
Research Site 11380-008
-
Kharkiv, 61176
-
Ukraine
Research Site 11380-001
-
Kyiv, 02002
-
Ukraine
Research Site 11380-002
-
Kyiv, 03037
-
Ukraine
Research Site 11380-003
-
Kyiv, 03049
-
Ukraine
Research Site 11380-004
-
Kyiv,
-
Ukraine
Research Site 11380-009
-
Zaporizhzhya,
-
Ukraine
Research Site 11380-006
-
Úzhgorod, 88000
-
Ukraine
United Kingdom
Research Site 11044-028
-
Bollington, SK10 5JH
Cheshire
United Kingdom
Research Site 11044-026
-
Bury,
-
United Kingdom
Research Site 11044-024
-
Cheadle Hulme,
-
United Kingdom
Research Site 11044-014
-
Chorley,
-
United Kingdom
Research Site 11044-012
-
Cornwell,
-
United Kingdom
Research Site 11044-010
-
Derby,
-
United Kingdom
Research Site 11044-006
-
Edgbaston,
-
United Kingdom
Research Site 11044-009
-
Exeter,
-
United Kingdom
Research Site 11044-001
-
Glasgow,
-
United Kingdom
Research Site 11044-008
-
Hexham,
-
United Kingdom
Research SIte 11044-020
-
Macclesfield,
-
United Kingdom
Research Site 11044-005
-
Manchester,
-
United Kingdom
Research Site 11044-025
-
Manchester,
-
United Kingdom
Research Site 11044-027
-
Manchester,
-
United Kingdom
Research Site 11044-029
-
Manchester,
-
United Kingdom
Research Site 11044-019
-
Plymouth,
-
United Kingdom
Research Site 11044-003
-
Reading,
-
United Kingdom
Research Site 11044-022
-
Sale,
-
United Kingdom
Research Site 11044-023
-
Sale,
-
United Kingdom
Research Site 11044-002
-
Stockton-on-Tees,
-
United Kingdom
Research Site 11044-021
-
Timperley,
-
United Kingdom
Research Site 11044-007
-
Wales,
-
United Kingdom
Research Site 11044-004
-
Waterloo,
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]