Clinical trial NCT03814187: Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ASCVD
Elevated Cholesterol
Heterozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Keywords: Inclisiran sodium
ASCVD
LDL-C
HeFH
HoFH
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 3275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.

Detailed description: This study was an open label, long term extension study in subjects with atherosclerotic cardiovascular disease (ASCVD), ASCVD-risk equivalents (eg, diabetes and familial hypercholesterolemia), or heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of LDL-C lowering therapies who have completed the inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3; NCT03060577), or any of the following Phase III lipid lowering studies: MDCO-PCS-17-03 (ORION-9; NCT03397121), MDCO-PCS-17-04 (ORION-10; NCT03399370), or MDCO-PCS-17-08 (ORION-11; NCT03400800).

The End of Study (EOS) visit in the previous feeder studies was Day 1 in this extension study.The duration that each subject participated in this study was a maximum of 3 years. However, for subjects from the Study ORION-3, the Sponsor decided to end the study prior to completion of their full 3-year of participation. It is recorded in the database as discontinuation was due to Sponsor's decision.

In this Phase III extension study, the same study drug of inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) was administered as a single subcutaneous (SC) dose every 180 days from the last dose in previous feeder study (except for subjects newly initiating inclisiran, who received the first two doses 90 days apart) until the end of the study.

On Day 1 (EOS visit in the feeder study), subjects from the previous feeder studies received blinded study medication except subjects from Study ORION-3. Subjects who received placebo in the previous Phase III feeder study received blinded inclisiran and subjects who received inclisiran in the previous feeder study received blinded placebo at this visit, so that subjects previously on placebo received the correct dosing regime, i.e. a dose at Day 1, Day 90 and every 180-days thereafter. Subjects previously treated with inclisiran did not need a dose of inclisiran to maintain every 180-dosing regime and therefore, were given placebo in order to maintain the blinding of the feeder study. Subjects that moved over from ORION-3 received the first study medication at Day 90, as this study was already open-label.

On Day 90, all subjects received inclisiran sodium 300 mg. This is 180 days after the last injection in the previous feeder study for subjects that received inclisiran and was the second dose of inclisiran for the subjects that received placebo in the feeder study. The EOS visit occurred at Day 1080.

This extension study allowed subjects continued access to inclisiran treatment and allowed the collection of additional efficacy and safety data for long-term use beyond the end of the feeder studies.

Eligibility criteria: Inclusion Criteria:

1. Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study \[MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)\] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
2. 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.
3. 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:

1. 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.
2. 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.
3. Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years,
4. 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.
5. 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:

   1. Women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
   2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
   3. Women who are surgically sterilized at least 3 months prior to enrollment.
6. Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study.
7. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:

   1. Subjects who are unable to communicate or to cooperate with the investigator
   2. 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)
   3. 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)
   4. 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
   5. 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.

Primary outcomes:
measure: Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk
timeFrame: From ORION-8 Day 1 to the end of study (up to 1080 days)
measure: Incidence of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From ORION-8 Day 1 to the end of study (up to 1080 days)
Secondary outcomes:
measure: Absolute Change in LDL-C From the Initial Feeder Study Baseline
timeFrame: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
measure: Percentage Change in LDL-C From the Initial Feeder Study Baseline
timeFrame: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
measure: Absolute Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C
timeFrame: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
measure: Percentage Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C
timeFrame: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
Other outcomes:
Locations:
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state: Alabama
city: Foley
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facility: Research Site 10001-138
state: Alabama
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city: Los Angeles
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facility: Research Site 90001-005
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city: Northridge
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state: California
city: Northridge
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city: Sacramento
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state: California
city: San Ramon
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state: California
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city: Spring Valley
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state: California
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city: Clearwater
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state: Florida
city: Clearwater
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city: Clearwater
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state: Florida
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city: Miami Springs
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state: Florida
city: Miami
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city: Miami
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city: Pembroke Pines
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city: Pembroke Pines
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city: Pembroke Pines
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city: Saint Petersburg
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state: Florida
city: Sarasota
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facility: Research Site 10001-123
state: Florida
city: Tampa
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facility: Research Site 10001-143
state: Florida
city: Atlanta
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facility: Research Site 10001-069
state: Georgia
city: Dunwoody
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facility: Research Site 10001-137
state: Georgia
city: Macon
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state: Georgia
city: Arlington Heights
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state: Illinois
city: Chicago
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facility: Research Site 10001-158
state: Illinois
city: Evanston
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state: Illinois
city: Indianapolis
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state: Iowa
city: Hutchinson
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city: Lexington
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state: Kentucky
city: Owensboro
country: United States
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state: Kentucky
city: Crowley
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state: Louisiana
city: Lake Charles
country: United States
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state: Louisiana
city: Monroe
country: United States
facility: Research Site 10001-101
state: Louisiana
city: Boston
country: United States
facility: Research Site 90001-004
state: Massachusetts
city: Flint
country: United States
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state: Michigan
city: Grandville
country: United States
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state: Michigan
city: Sterling Heights
country: United States
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state: Michigan
city: Troy
country: United States
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state: Michigan
city: Edina
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state: Minnesota
city: Saint Paul
country: United States
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state: Minnesota
city: Saint Louis
country: United States
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city: Saint Louis
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state: Montana
city: Omaha
country: United States
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city: Omaha
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city: Las Vegas
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state: North Carolina
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state: Ohio
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state: Ohio
city: Cincinnati
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state: Ohio
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state: Pennsylvania
city: Anderson
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city: Greer
country: United States
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state: South Carolina
city: Greer
country: United States
facility: Research Site 10001-075.
state: South Carolina
city: Myrtle Beach
country: United States
facility: Research Site 10001-111
state: South Carolina
city: Pelzer
country: United States
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Athens
country: United States
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state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Knoxville
country: United States
facility: Research Site 10001-118
state: Tennessee
city: Knoxville
country: United States
facility: Research Site 10001-106
state: Tennessee
city: Amarillo
country: United States
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state: Texas
city: Austin
country: United States
facility: Research Site 10001-087
state: Texas
city: Austin
country: United States
facility: Research Site 10001-117
state: Texas
city: Dallas
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state: Texas
city: Edinburg
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
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state: Texas
city: Houston
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state: Texas
city: Houston
country: United States
facility: Research Site 10001-061
state: Texas
city: Houston
country: United States
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state: Texas
city: New Braunfels
country: United States
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state: Texas
city: Round Rock
country: United States
facility: Research Site 10001-079
state: Texas
city: San Antonio
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state: Texas
city: Schertz
country: United States
facility: Research Site 10001-083
state: Texas
city: Shavano Park
country: United States
facility: Research Site 10001-149
state: Texas
city: Tomball
country: United States
facility: Research Site 10001-045
state: Texas
city: Layton
country: United States
facility: Research Site 10001-005
state: Utah
city: Salt Lake City
country: United States
facility: Research Site 10001-002
state: Utah
city: Salt Lake City
country: United States
facility: Research Site 10001-052
state: Utah
city: Falls Church
country: United States
facility: Research Site 10001-093
state: Virginia
city: Manassas
country: United States
facility: Research Site 10001-085
state: Virginia
city: Midlothian
country: United States
facility: Research Site 10001-094
state: Virginia
city: Richmond
country: United States
facility: Research Site 10001-023
state: Virginia
city: Suffolk
country: United States
facility: Research Site 10001-029
state: Virginia
city: Tacoma
country: United States
facility: Research Site 10001-114
state: Washington
city: Chicoutimi
country: Canada
facility: Research Site 90011-005
state: Quebec
city: Montréal
country: Canada
facility: Research Site 90011-001
state: Quebec
city: Québec
country: Canada
facility: Research Site 90011-002
state: Quebec
city: Chomutov
country: Czechia
facility: Research Site 11420-002
city: Praha
country: Czechia
facility: Research Site 90420-001
city: Praha
country: Czechia
facility: Research Site 90420-006
city: Uherské Hradiště
country: Czechia
facility: Research Site 11420-003
city: Aalborg
country: Denmark
facility: Research Site 90045-001
state: Nordjylland
city: Esbjerg
country: Denmark
facility: Research Site 90045-004
city: Herning
country: Denmark
facility: Research Site 90045-003
city: Hvidovre
country: Denmark
facility: Research Site 90045-006
city: Roskilde
country: Denmark
facility: Research Site 90045-002
city: Viborg
country: Denmark
facility: Research Site 90045-005
city: Berlin
country: Germany
facility: Research Site 11049-006
city: Bochum
country: Germany
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city: Frankfurt
country: Germany
facility: Research Site 11049-003
city: Heidelberg
country: Germany
facility: Research Site 11049-001
city: Heidelberg
country: Germany
facility: Research Site 11049-007
city: Budapest
country: Hungary
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city: Zalaegerszeg
country: Hungary
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country: Netherlands
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city: Hoorn
country: Netherlands
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country: Netherlands
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facility: Research SIte 11048-016
city: Bydgoszcz
country: Poland
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city: Bydgoszcz
country: Poland
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city: Gdańsk
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city: Katowice
country: Poland
facility: Research SIte 11048-012
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facility: Research Site 11048-003
city: Kraków
country: Poland
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country: Poland
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country: Poland
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country: Poland
facility: Research Site 11048-006
city: Warsaw
country: Poland
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country: Poland
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country: South Africa
facility: Research Site 90027-008
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country: South Africa
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country: South Africa
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state: Western Cape
city: Somerset West
country: South Africa
facility: Research Site 90027-005
state: Western Cape
city: Córdoba
country: Spain
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city: Zaragoza
country: Spain
facility: Research Site 90034-002
state: Aragon
city: Barcelona
country: Spain
facility: Research Site 90034-005
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site 90034-006
state: Cataluna
city: Reus
country: Spain
facility: Research Site 90034-001
state: Cataluna
city: La Coruña
country: Spain
facility: Research Site 90034-003
state: Galicia
city: Göteborg
country: Sweden
facility: Research Site 90046-002
city: Stockholm
country: Sweden
facility: Research Site 90046-001
city: Stockholm
country: Sweden
facility: Research Site 90046-003
city: Cherkasy
country: Ukraine
facility: Research Site 11380-005
city: Kharkiv
country: Ukraine
facility: Research Site 11380-008
city: Kyiv
country: Ukraine
facility: Research Site 11380-001
city: Kyiv
country: Ukraine
facility: Research Site 11380-002
city: Kyiv
country: Ukraine
facility: Research Site 11380-003
city: Kyiv
country: Ukraine
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city: Zaporizhzhya
country: Ukraine
facility: Research Site 11380-009
city: Úzhgorod
country: Ukraine
facility: Research Site 11380-006
city: Bollington
country: United Kingdom
facility: Research Site 11044-028
state: Cheshire
city: Bury
country: United Kingdom
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city: Cheadle Hulme
country: United Kingdom
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city: Chorley
country: United Kingdom
facility: Research Site 11044-014
city: Cornwell
country: United Kingdom
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city: Derby
country: United Kingdom
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city: Edgbaston
country: United Kingdom
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city: Exeter
country: United Kingdom
facility: Research Site 11044-009
city: Glasgow
country: United Kingdom
facility: Research Site 11044-001
city: Hexham
country: United Kingdom
facility: Research Site 11044-008
city: Macclesfield
country: United Kingdom
facility: Research SIte 11044-020
city: Manchester
country: United Kingdom
facility: Research Site 11044-005
city: Manchester
country: United Kingdom
facility: Research Site 11044-025
city: Manchester
country: United Kingdom
facility: Research Site 11044-027
city: Manchester
country: United Kingdom
facility: Research Site 11044-029
city: Plymouth
country: United Kingdom
facility: Research Site 11044-019
city: Reading
country: United Kingdom
facility: Research Site 11044-003
city: Sale
country: United Kingdom
facility: Research Site 11044-022
city: Sale
country: United Kingdom
facility: Research Site 11044-023
city: Stockton-on-Tees
country: United Kingdom
facility: Research Site 11044-002
city: Timperley
country: United Kingdom
facility: Research Site 11044-021
city: Wales
country: United Kingdom
facility: Research Site 11044-007
city: Waterloo
country: United Kingdom
facility: Research Site 11044-004
Study officials:
affiliation: Mayo Clinic
name: Scott Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.