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AzTrials

ASCVDPhase 3ORION-8NCT03814187

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

A Phase 3 study testing Inclisiran Sodium in people with ASCVD and Elevated Cholesterol, run by Novartis Pharmaceuticals at 238 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inclisiran Sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,275 participants
Where
238 sitesin 13 countries
Study dates
16 Apr 2019to 13 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

238 sites in 13 countries.

238 sites in 13 countries

United States141 sites

  • Research Site 10001-016

    Akron, Ohio, 443311

  • Research Site 10001-054

    Albany, New York, 12206

  • Research Site 10001-100

    Amarillo, Texas, 79106

  • Research Site 10001-001

    Anderson, South Carolina, 29621

  • Research Site 10001-059

    Arlington Heights, Illinois, 60005

  • Research Site 10001-146

    Athens, Tennessee, 37303

  • Research Site 10001-069

    Atlanta, Georgia, 30342

  • Research Site 10001-087

    Austin, Texas, 78726

  • Research Site 10001-117

    Austin, Texas, 78756

  • Research Site 10001-073

    Beverly Hills, California, 90211

  • Research Site 10001-122

    Binghamton, New York, 13901

  • Research Site 10001-015

    Birmingham, Alabama, 35211

  • Research Site 90001-047

    Boca Raton, Florida, 33434

  • Research Site 90001-004

    Boston, Massachusetts, 02114

  • Research Site 10001-060

    Bridgewater, New Jersey, 08807

  • Research Site 90001-012

    Butte, Montana, 59701

  • Research Site 10001-050

    Canoga Park, California, 91303

  • Research Site 10001-011

    Carlsbad, California, 92008

  • Research Site 10001-063

    Cary, North Carolina, 27518

  • Research Site 10001-013

    Chandler, Arizona, 85224

  • Research Site 10001-158

    Chicago, Illinois, 60652

  • Research Site 10001-120

    Cincinnati, Ohio, 45219

  • Research Site 90001-002

    Cincinnati, Ohio, 45227

  • Research Site 10001-010

    Cincinnati, Ohio, 45236

  • Research Site 10001-134

    Cincinnati, Ohio, 45246

  • Research Site 10001-084

    Clearwater, Florida, 33756

  • Research Site 10001-155

    Clearwater, Florida, 33756

  • Research Site 10001-099

    Clearwater, Florida, 33761

  • Research Site 10001-014

    Columbus, Ohio, 43212

  • Research Site 10001-144

    Crowley, Louisiana, 70526

  • Research Site 10001-009

    Dallas, Texas, 75234

  • Research Site 10001-141

    Dayton, Ohio, 45419

  • Research Site 10001-127

    Daytona Beach, Florida, 32117

  • Research Site 10001-137

    Dunwoody, Georgia, 30338

  • Research Site 10001-018

    Edina, Minnesota, 55435

  • Research Site 10001-068

    Edinburg, Texas, 78503

  • Research Site 10001-065

    El Cajon, California, 92020

  • Research Site 10001-128

    Endwell, New York, 13760

  • Research Site 10001-036

    Evanston, Illinois, 60201

  • Research Site 10001-093

    Falls Church, Virginia, 22042

  • Research Site 10001-119

    Fleming Island, Florida, 32003

  • Research Site 10001-024

    Flint, Michigan, 48504

  • Research Site 10001-138

    Foley, Alabama, 36535

  • Research Site 10001-070

    Fort Lauderdale, Florida, 33308

  • Research Site 10001-095

    Grandville, Michigan, 49418

  • Research Site 10001-064

    Greensboro, North Carolina, 27401

  • Research Site 10001-006

    Greer, South Carolina, 29651

  • Research Site 10001-075.

    Greer, South Carolina, 29651

  • Research Site 10001-067

    Hialeah, Florida, 33012

  • Research Site 10001-031

    Houston, Texas, 77002

  • Research Site 10001-088

    Houston, Texas, 77024

  • Research Site 10001-091

    Houston, Texas, 77027

  • Research Site 10001-061

    Houston, Texas, 77058

  • Research Site 10001-032

    Houston, Texas, 77070

  • Research Site 10001-113

    Huntsville, Alabama, 35801

  • Research Site 10001-028

    Hutchinson, Kansas, 67502

  • Research Site 10001-082

    Indianapolis, Indiana, 46260

  • Research Site 10001-139

    Jacksonville, Florida, 32204

  • Research Site 10001-039

    Jacksonville, Florida, 32216

  • Research Site 10001-098

    Jacksonville, Florida, 32216

  • Research Site 10001-130

    Kingsport, Tennessee, 37660

  • Research Site 10001-118

    Knoxville, Tennessee, 37909

  • Research Site 10001-106

    Knoxville, Tennessee, 37917

  • Research Site 10001-041

    Lake Charles, Louisiana, 70601

  • Research Site 90001-112

    Las Vegas, Nevada, 89119

  • Research Site 10001-124

    Las Vegas, Nevada, 89121

  • Research Site 10001-005

    Layton, Utah, 84041

  • Research Site 10001-125

    Lexington, Kentucky, 40503

  • Research Site 10001-108

    Lexington, Kentucky, 40504

  • Research Site 10001-150

    Los Angeles, California, 90022

  • Research Site 10001-092

    Macon, Georgia, 31210

  • Research Site 10001-085

    Manassas, Virginia, 20110

  • Research Site 10001-148

    Marion, Ohio, 43302

  • Research Site 10001-077

    Mesa, Arizona, 85213

  • Research Site 10001-081

    Miami, Florida, 33126

  • Research Site 10001-140

    Miami, Florida, 33126

  • Research Site 10001-142

    Miami, Florida, 33126

  • Research Site 10001-030

    Miami, Florida, 33165

  • Research Site 10001-116

    Miami, Florida, 33183

  • Research Site 10001-080

    Miami Springs, Florida, 33166

  • Research Site 10001-094

    Midlothian, Virginia, 23114

  • Research Site 90001-005

    Mission Viejo, California, 92691

  • Research Site 10001-058

    Mobile, Alabama, 36608

  • Research Site 10001-101

    Monroe, Louisiana, 71201

  • Research Site 10001-037

    Montgomery, Alabama, 36117

  • Research Site 10001-145

    Mooresville, North Carolina, 28117

  • Research Site 10001-111

    Myrtle Beach, South Carolina, 29588

  • Research Site 10001-057

    New Braunfels, Texas, 78130

  • Research Site 10001-042

    New Windsor, New York, 12553

  • Research Site 10001-043

    Northridge, California, 91324

  • Research Site 10001-022

    Northridge, California, 91325

  • Research Site 10001-053

    Omaha, Nebraska, 68134

  • Research Site 10001-021

    Omaha, Nebraska, 68144

  • Research Site 10001-107

    Owensboro, Kentucky, 42303

  • Research Site 10001-133

    Pelzer, South Carolina, 29669

  • Research Site 10001-027

    Pembroke Pines, Florida, 33024

  • Research Site 10001-115

    Pembroke Pines, Florida, 33027

  • Research Site 10001-048

    Pembroke Pines, Florida, 33029

  • Research Site 10001-147

    Pembroke Pines, Florida, 33029

  • Research Site 10001-136

    Phoenix, Arizona, 85014

  • Research Site 10001-003

    Pinellas Park, Florida, 33781

  • Research Site 10001-104

    Ponte Vedra, Florida, 32081

  • Research Site 10001-129

    Poughkeepsie, New York, 12601

  • Research Site 10001-103

    Rapid City, South Dakota, 57701

  • Research Site 10001-023

    Richmond, Virginia, 23294

  • Research Site 10001-079

    Round Rock, Texas, 78681

  • Research Site 10001-033

    Sacramento, California, 95821-2134

  • Research Site 10001-090

    Saint Augustine, Florida, 32086

  • Research Site 90001-056

    Saint Paul, Minnesota, 55102

  • Research Site 10001-002

    Salt Lake City, Utah, 84123

  • Research Site 10001-052

    Salt Lake City, Utah, 94107

  • Research Site 10001-071

    San Antonio, Texas, 78229

  • Research Site 10001-105

    San Ramon, California, 94582

  • Research Site 10001-008

    Santa Rosa, California, 95405

  • Research Site 10001-076

    Saraland, Alabama, 36571

  • Research Site 10001-123

    Sarasota, Florida, 34239-3513

  • Research Site 10001-083

    Schertz, Texas, 78154

  • Research Site 10001-149

    Shavano Park, Texas, 78231

  • Research Site 10001-046

    Shelby, North Carolina, 28150

  • Research Site 10001-153

    Spring Valley, California, 91978

  • Research Site 10001-156

    St Louis, Missouri, 63136

  • Research Site 10001-007

    St Louis, Missouri, 63141

  • Research Site 10001-102

    St. Petersburg, Florida, 33713

  • Research Site 90001-015

    Stanford, California, 94305

  • Research Site 10001-078

    Sterling Heights, Michigan, 48310

  • Research Site 10001-029

    Suffolk, Virginia, 23435

  • Research Site 90001-014

    Summit, New Jersey, 07901

  • Research Site 10001-051

    Surprise, Arizona, 85374

  • Research Site 10001-114

    Tacoma, Washington, 98405

  • Research Site 10001-143

    Tampa, Florida, 33614

  • Research Site 10001-045

    Tomball, Texas, 77375

  • Research Site 10001-044

    Torrance, California, 90502

  • Research Site 10001-034

    Troy, Michigan, 48098

  • Research Site 10001-019

    Tucson, Arizona, 85712

  • Research Site 10001-004

    Tucson, Arizona, 85741

  • Research Site 10001-132

    Tucson, Arizona, 85745

  • Research Site 10001-040

    Valparaiso, Indiana, 46383

  • Research Site 10001-055

    Warren Township, New Jersey, 07059

  • Research Site 10001-074

    West Des Moines, Iowa, 50266

  • Research Site 10001-110

    Williamsville, New York, 14221

  • Research Site 10001-109

    Wyomissing, Pennsylvania, 19610

Other trials in United States

United Kingdom23 sites

  • Research Site 11044-028

    Bollington, Cheshire, SK10 5JH

  • Research Site 11044-026

    Bury

  • Research Site 11044-024

    Cheadle Hulme

  • Research Site 11044-014

    Chorley

  • Research Site 11044-012

    Cornwell

  • Research Site 11044-010

    Derby

  • Research Site 11044-006

    Edgbaston

  • Research Site 11044-009

    Exeter

  • Research Site 11044-001

    Glasgow

  • Research Site 11044-008

    Hexham

  • Research SIte 11044-020

    Macclesfield

  • Research Site 11044-005

    Manchester

  • Research Site 11044-025

    Manchester

  • Research Site 11044-027

    Manchester

  • Research Site 11044-029

    Manchester

  • Research Site 11044-019

    Plymouth

  • Research Site 11044-003

    Reading

  • Research Site 11044-022

    Sale

  • Research Site 11044-023

    Sale

  • Research Site 11044-002

    Stockton-on-Tees

  • Research Site 11044-021

    Timperley

  • Research Site 11044-007

    Wales

  • Research Site 11044-004

    Waterloo

Other trials in United Kingdom

Poland18 sites

  • Research SIte 11048-016

    Brzozowie

  • Research Site 11048-018

    Bydgoszcz, 85-079

  • Research Site 11048-011

    Bydgoszcz

  • Research Site 11048-004

    Gdansk

  • Research Site 11048-005

    Gdynia

  • Research Site 11048-007

    Katowice

  • Research SIte 11048-012

    Katowice

  • Research Site 11048-003

    Krakow

  • Research SIte 11048-014

    Krakow

  • Research Site 11048-008

    Lublin

  • Research Site 11048-001

    Poznan

  • Research Site 11048-019

    Ruda Śląska, 41-709

  • Research SIte 11048-013

    Rzeszów

  • Research SIte 11048-015

    Tarnów

  • Research Site 11048-006

    Warsaw

  • Research Site 11048-009

    Warsaw

  • Research Site 11048-002

    Wroclaw

  • Research Site 11048-010

    Wroclaw

Other trials in Poland

South Africa12 sites

  • Research Site 90027-008

    Bellville, Cape Town, 7530

  • Research Site 90027-003

    Bloemfontein, Free State, 9301

  • Research Site 90027-001

    Cape Town, Western Cape, 7500

  • Research Site 90027-010

    Johannesburg, Gauteng, 2193

  • Research Site 11027-005

    Kempton Park, Gauteng, 1619

  • Research Site 11027-007

    Kuils River, Western Cape, 7580

  • Research Site 90027-007

    Lyttelton, Cape Town, 0157

  • Research Site 11027-013

    Paarl, Western Cape, 7646

  • Research Site 90027-006

    Pretoria, Gauteng, 0184

  • Research Site 90027-004

    Somerset West, Western Cape, 7130

  • Research Site 90027-005

    Somerset West, Western Cape, 7130

  • Research Site 90027-009

    Witbank, Gauteng, 1035

Other trials in South Africa

Ukraine8 sites

  • Research Site 11380-005

    Cherkasy

  • Research Site 11380-008

    Kharkiv, 61176

  • Research Site 11380-001

    Kyiv, 02002

  • Research Site 11380-002

    Kyiv, 03037

  • Research Site 11380-003

    Kyiv, 03049

  • Research Site 11380-004

    Kyiv

  • Research Site 11380-006

    Uzhhorod, 88000

  • Research Site 11380-009

    Zaporizhzhya

Other trials in Ukraine

Denmark6 sites

  • Research Site 90045-001

    Aalborg, North Denmark, 9000

  • Research Site 90045-004

    Esbjerg, 6700

  • Research Site 90045-003

    Herning, 7400

  • Research Site 90045-006

    Hvidovre, 2650

  • Research Site 90045-002

    Roskilde, 4000

  • Research Site 90045-005

    Viborg, 8800

Other trials in Denmark

Spain6 sites

  • Research Site 90034-003

    A Coruña, Galicia, 15002

  • Research Site 90034-005

    Barcelona, Catalonia, 08036

  • Research Site 90034-006

    Barcelona, Catalonia, 08907

  • Research Site 90034-004

    Córdoba, Andalusia, 14004

  • Research Site 90034-001

    Reus, Catalonia, 43204

  • Research Site 90034-002

    Zaragoza, Aragon, 5009

Other trials in Spain

Germany5 sites

  • Research Site 11049-006

    Berlin, 12627

  • Research Site 11049-002

    Bochum, 47787

  • Research Site 11049-003

    Frankfurt, 60313

  • Research Site 11049-001

    Heidelberg, 69120

  • Research Site 11049-007

    Heidelberg, 69120

Other trials in Germany

Netherlands5 sites

  • Research Site 90031-001

    Amersfoort, 3813 TZ

  • Research Site 90031-003

    Amsterdam, 1105 AZ

  • Research Site 90031-006

    Goes, 4462 RA

  • Research Site 90031-009

    Hoorn, 1624 NP

  • Research Site 90031-005

    Utrecht

Other trials in Netherlands

Czechia4 sites

  • Research Site 11420-002

    Chomutov, 430 02

  • Research Site 90420-001

    Prague, 140 21

  • Research Site 90420-006

    Prague, 180 81

  • Research Site 11420-003

    Uherské Hradiště, 686 01

Other trials in Czechia

Hungary4 sites

  • Research Site 11036-001

    Budapest

  • Research Site 11036-004

    Debrecen

  • Research Site 11036-002

    Hatvan

  • Research Site 11036-003

    Zalaegerszeg

Other trials in Hungary

Canada3 sites

  • Research Site 90011-005

    Chicoutimi, Quebec, G7H 7K9

  • Research Site 90011-001

    Montreal, Quebec, H2W 1R7

  • Research Site 90011-002

    Québec, Quebec, GIV 4W2

Other trials in Canada

Sweden3 sites

  • Research Site 90046-002

    Gothenburg, SE-41346

  • Research Site 90046-001

    Stockholm, SE-11446

  • Research Site 90046-003

    Stockholm, SE-14186

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Inclisiran Sodium
Keywords
Inclisiran sodium, ASCVD, LDL-C, HeFH, HoFH
Medical subject headings
Hypercholesterolemia, Homozygous Familial Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inclisiran SodiumDrug

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

Study groups in NCT03814187
Study groupRoleWhat they receive
InclisiranExperimentalInclisiran sodium 300 milligrams (mg) was administered as a single SC injection on Day 1*, 90, then every 180 days to Day 990. *Subjects who received blinded placebo in the feeder study received blinded inclisiran and subjects who received blinded inclisiran in the feeder study received blinded placebo on Day 1 in ORION-8. Subjects from the open label ORION-3 study did not receive any injection of study drug on Day 1. Their first dose of study medication was at day 90
Receives: Drug: Inclisiran Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk

    The primary objective of the study is to evaluate the effect of inclisiran treatment on the proportion of subjects achieving prespecified LDL-C targets at end of study (EOS).

    Target is <70 mg/dL for atherosclerotic cardiovascular disease (ASCVD) subjects and <100 mg/dL for ASCVD risk equivalent subjects.

    Risk equivalent subjects are defined as either type 2 diabetes, familial hypercholesterolemia or a 10-year risk of a cardiovascular event ≥20% as assessed by the Framingham Risk Score or equivalent; without a medical history of coronary heart disease , cerebrovascular disease or peripheral artery disease.

    Measured: From ORION-8 Day 1 to the end of study (up to 1080 days)

  2. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Safety assessments include adverse events and serious adverse events until the end of study.

    End of study visit occured at least 90 days following the last inclisiran dose once a decision was made to end the study (either by the subject, investigator or sponsor). For subjects prematurely and permanently discontinued from study treatment, who were not willing to return within the 90 day timeframe, the EOS visit was scheduled as soon as possible, or if decision to discontinue and not return was made at a specific visit, this visit became the EOS visit.

    Measured: From ORION-8 Day 1 to the end of study (up to 1080 days)

Secondary outcomes (4)

  1. Absolute Change in LDL-C From the Initial Feeder Study Baseline

    Absolute change from baseline in low density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran on LDL-C levels.

    Measured: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)

  2. Percentage Change in LDL-C From the Initial Feeder Study Baseline

    Percentage change from baseline in low density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran on LDL-C levels.

    Measured: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)

  3. Absolute Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C

    Absolute change from baseline in total cholesterol, triglycerides and high density lipoprotein cholesterol (HDL-C) was calculated to evaluate the effect of inclisiran on other lipids and lipoproteins.

    Measured: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)

  4. Percentage Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C

    Percentage change from baseline in total cholesterol (TC), triglycerides and high density lipoprotein cholesterol (HDL-C) was calculated to evaluate the effect of inclisiran on other lipids and lipoproteins.

    Measured: Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start16 Apr 2019
  3. Primary completion13 Feb 2023
  4. Study completion13 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03814187
Sponsor's protocol ID
MDCO-PCS-17-05
Other IDs
CKJX839A12306B, 2017-003092-55, 2017
Acronym
ORION-8
Status last verified
Feb 2024
First submitted
17 Jan 2019
Last updated
6 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Wright RS, Raal FJ, Koenig W, Landmesser U, Leiter LA, Vikarunnessa S, Lesogor A, Maheux P, Talloczy Z, Zang X, Schwartz GG, Ray KK. Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial. Cardiovasc Res. 2024 Oct 14;120(12):1400-1410. doi: 10.1093/cvr/cvae109.

    PubMed 38753448

  • 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.

    PubMed 33990512

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inclisiran Sodium in people with ASCVD and Elevated Cholesterol, run by Novartis Pharmaceuticals at 238 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 238 sites in United States, United Kingdom, Poland, South Africa, Ukraine and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk (time frame: From ORION-8 Day 1 to the end of study (up to 1080 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03814187, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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