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

Last updated: February 9, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

High Cholesterol (Hyperlipidemia)

Hypercholesterolemia

Familial Hypercholesterolemia

Treatment

Inclisiran Sodium

Clinical Study ID

NCT03814187
MDCO-PCS-17-05
CKJX839A12306B
2017-003092-55
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 receivedthe last dose of study drug and completed the final study visit per applicableprotocol.
  2. On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previousstudy with no planned medication or dose change during study participation.
  3. Willing and able to give informed consent before initiation of any study-relatedprocedures and willing to comply with all required study procedures.

Exclusion

Exclusion Criteria:

  1. Any uncontrolled or serious disease, or any medical or surgical condition, that mayeither interfere with participation in the clinical study, and/or put the subject atsignificant risk [according to investigator's (or delegate's) judgment] if he/sheparticipates in the clinical study.
  2. An underlying known disease, or surgical, physical, or medical condition that, in theopinion of the investigator (or delegate) might interfere with interpretation of theclinical study results.
  3. Severe concomitant noncardiovascular disease that carries the risk of reducing lifeexpectancy to less than 3 years,
  4. Active liver disease defined as any known current infectious, neoplastic, or metabolicpathology of the liver or unexplained alanine aminotransferase (ALT), aspartateaminotransferase (AST), elevation >3x the upper limit of normal (ULN), or totalbilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder studyprior to study entry visit.
  5. Females who are pregnant or nursing, or who are of childbearing potential andunwilling to use at least one method of acceptable effective contraception (eg, oralcontraceptives, barrier methods, approved contraceptive implant, long-term injectablecontraception, intrauterine device) for the entire duration of the study. Exemptionsfrom this criterion:
  6. Women >2 years postmenopausal (defined as 1 year or longer since last menstrualperiod) and more than 55 years of age.
  7. Postmenopausal women (as defined above) and less than 55 years of age with anegative pregnancy test within 24 hours of randomization.
  8. Women who are surgically sterilized at least 3 months prior to enrollment.
  9. Planned use of other investigational medicinal products other than inclisiran ordevices during the course of the study.
  10. Any condition that according to the investigator could interfere with the conduct ofthe study, such as but not limited to:
  11. Subjects who are unable to communicate or to cooperate with the investigator
  12. Unable to understand the protocol requirements, instructions and study-relatedrestrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcoholdependency)
  13. Unlikely to comply with the protocol requirements, instructions, andstudy-related restrictions (eg, uncooperative attitude, inability to return forfollow-up visits, and improbability of completing the study)
  14. Have any medical or surgical condition, which in the opinion of the investigatorwould put the subject at increased risk from participating in the study
  15. Persons directly involved in the conduct of the study. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.

Study Design

Total Participants: 3275
Treatment Group(s): 1
Primary Treatment: Inclisiran Sodium
Phase: 3
Study Start date:
April 16, 2019
Estimated Completion Date:
February 13, 2023

Study 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.

Connect with a study center

  • Research Site 90011-005

    Chicoutimi, Quebec G7H 7K9
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    Montréal, Quebec H2W 1R7
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    Hvidovre, 2650
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    Viborg, 8800
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    Berlin, 12627
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    Site Not Available

  • Research Site 10001-001

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Research Site 10001-062

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Research Site 10001-006

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Research Site 10001-075.

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Research Site 10001-111

    Myrtle Beach, South Carolina 29588
    United States

    Site Not Available

  • Research Site 10001-133

    Pelzer, South Carolina 29669
    United States

    Site Not Available

  • Research Site 10001-026

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Research Site 10001-103

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Research Site 10001-146

    Athens, Tennessee 37303
    United States

    Site Not Available

  • Research Site 10001-152

    Greeneville, Tennessee 37745
    United States

    Site Not Available

  • Research Site 10001-130

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Research Site 10001-106

    Knoxville, Tennessee 37917
    United States

    Site Not Available

  • Research Site 10001-118

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Research Site 10001-100

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Research Site 10001-087

    Austin, Texas 78726
    United States

    Site Not Available

  • Research Site 10001-117

    Austin, Texas 78756
    United States

    Site Not Available

  • Research Site 10001-009

    Dallas, Texas 75234
    United States

    Site Not Available

  • Research Site 10001-068

    Edinburg, Texas 78503
    United States

    Site Not Available

  • Research Site 10001-126

    Fort Worth, Texas 76106
    United States

    Site Not Available

  • Research Site 10001-031

    Houston, Texas 77002
    United States

    Site Not Available

  • Research Site 10001-032

    Houston, Texas 77070
    United States

    Site Not Available

  • Research Site 10001-061

    Houston, Texas 77058
    United States

    Site Not Available

  • Research Site 10001-088

    Houston, Texas 77024
    United States

    Site Not Available

  • Research Site 10001-091

    Houston, Texas 77027
    United States

    Site Not Available

  • Research Site 10001-025

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Research Site 10001-057

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Research Site 10001-079

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Research Site 10001-071

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site 10001-083

    Schertz, Texas 78154
    United States

    Site Not Available

  • Research Site 10001-149

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Research Site 10001-045

    Tomball, Texas 77375
    United States

    Site Not Available

  • Research Site 10001-005

    Layton, Utah 84041
    United States

    Site Not Available

  • Research Site 10001-002

    Salt Lake City, Utah 84123
    United States

    Site Not Available

  • Research Site 10001-052

    Salt Lake City, Utah 94107
    United States

    Site Not Available

  • Research Site 10001-093

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Research Site 10001-085

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Research Site 10001-094

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Research Site 10001-023

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Research Site 10001-029

    Suffolk, Virginia 23435
    United States

    Site Not Available

  • Research Site 10001-114

    Tacoma, Washington 98405
    United States

    Site Not Available

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