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Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

NCT ID: NCT03399370

Last Updated: 2020-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2019-09-17

Brief Summary

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This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.

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Detailed Description

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Conditions

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ASCVD Elevated Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Saline Solution

Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Inclisiran

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.

Group Type EXPERIMENTAL

Inclisiran Sodium

Intervention Type DRUG

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

Interventions

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Inclisiran Sodium

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Saline Solution

Eligibility Criteria

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Inclusion Criteria

1. Male or female participants ≥18 years of age.
2. History of ASCVD (coronary heart disease \[CHD\], cardiovascular disease \[CVD\], or peripheral arterial disease \[PAD\]).
3. Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
4. Fasting triglyceride \<4.52 mmol/L (\<400 mg/dL) at screening.
5. Participants on statins should be receiving a maximally tolerated dose.
6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.

Exclusion Criteria

1. New York Heart Association (NYHA) class IV heart failure.
2. Uncontrolled cardiac arrhythmia
3. Uncontrolled severe hypertension
4. Active liver disease
5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or 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. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Research Site 10001-015

Birmingham, Alabama, United States

Site Status

Research Site 10001-138

Foley, Alabama, United States

Site Status

Research Site 10001-113

Huntsville, Alabama, United States

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Research Site 10001-058

Mobile, Alabama, United States

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Research Site 10001-037

Montgomery, Alabama, United States

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Research Site 10001-076

Saraland, Alabama, United States

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Research Site 10001-013

Chandler, Arizona, United States

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Research Site 10001-077

Mesa, Arizona, United States

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Research Site 10001-136

Phoenix, Arizona, United States

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Research Site 10001-051

Surprise, Arizona, United States

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Research Site 10001-019

Tucson, Arizona, United States

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Research Site 10001-004

Tucson, Arizona, United States

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Research Site 10001-132

Tucson, Arizona, United States

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Research Site 10001-073

Beverly Hills, California, United States

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Research Site 10001-050

Canoga Park, California, United States

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Research Site 10001-011

Carlsbad, California, United States

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Research Site 10001-065

El Cajon, California, United States

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Research Site 10001-150

Los Angeles, California, United States

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Research Site 10001-043

Northridge, California, United States

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Research Site 10001-022

Northridge, California, United States

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Research Site 10001-033

Sacramento, California, United States

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Research Site 10001-105

San Ramon, California, United States

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Research Site 10001-008

Santa Rosa, California, United States

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Research Site 10001-153

Spring Valley, California, United States

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Research Site 10001-044

Torrance, California, United States

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Research Site 10001-047

Boca Raton, Florida, United States

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Research Site 10001-084

Clearwater, Florida, United States

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Research Site 10001-155

Clearwater, Florida, United States

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Research Site 10001-099

Clearwater, Florida, United States

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Research Site 10001-127

Daytona Beach, Florida, United States

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Research Site 10001-119

Fleming Island, Florida, United States

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Research Site 10001-070

Fort Lauderdale, Florida, United States

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Research Site 10001-067

Hialeah, Florida, United States

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Research Site 10001-139

Jacksonville, Florida, United States

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Research Site 10001-039

Jacksonville, Florida, United States

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Research Site 10001-098

Jacksonville, Florida, United States

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Research Site 10001-081

Miami, Florida, United States

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Research Site 10001-140

Miami, Florida, United States

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Research Site 10001-142

Miami, Florida, United States

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Research Site 10001-030

Miami, Florida, United States

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Research Site 10001-089

Miami, Florida, United States

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Research Site 10001-116

Miami, Florida, United States

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Research Site 10001-080

Miami Springs, Florida, United States

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Research Site 10001-027

Pembroke Pines, Florida, United States

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Research Site 10001-115

Pembroke Pines, Florida, United States

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Research Site 10001-048

Pembroke Pines, Florida, United States

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Research Site 10001-147

Pembroke Pines, Florida, United States

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Research Site 10001-003

Pinellas Park, Florida, United States

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Research Site 10001-104

Ponte Vedra, Florida, United States

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Research Site 10001-090

Saint Augustine, Florida, United States

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Research Site 10001-123

Sarasota, Florida, United States

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Research Site 10001-102

St. Petersburg, Florida, United States

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Research Site 10001-038

Tampa, Florida, United States

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Research Site 10001-143

Tampa, Florida, United States

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Research Site 10001-069

Atlanta, Georgia, United States

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Research Site 10001-137

Dunwoody, Georgia, United States

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Research Site 10001-092

Macon, Georgia, United States

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Research Site 10001-059

Arlington Heights, Illinois, United States

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Research Site 10001-158

Chicago, Illinois, United States

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Research Site 10001-035

Chicago, Illinois, United States

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Research Site 10001-036

Evanston, Illinois, United States

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Research Site 10001-082

Indianapolis, Indiana, United States

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Research Site 1001-020

Sellersburg, Indiana, United States

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Research Site 10001-040

Valparaiso, Indiana, United States

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Research Site 10001-074

West Des Moines, Iowa, United States

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Research Site 10001-028

Hutchinson, Kansas, United States

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Research Site 10001-125

Lexington, Kentucky, United States

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Research Site 10001-108

Lexington, Kentucky, United States

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Research Site 10001-107

Owensboro, Kentucky, United States

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Research Site 10001-144

Crowley, Louisiana, United States

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Research Site 10001-041

Lake Charles, Louisiana, United States

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Research Site 10001-101

Monroe, Louisiana, United States

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Research Site 10001-024

Flint, Michigan, United States

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Research Site 10001-095

Grandville, Michigan, United States

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Research Site 10001-078

Sterling Heights, Michigan, United States

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Research Site 10001-034

Troy, Michigan, United States

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Research Site 10001-018

Edina, Minnesota, United States

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Research Site 10001-056

Saint Paul, Minnesota, United States

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Research Site 10001-156

St Louis, Missouri, United States

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Research Site 10001-007

St Louis, Missouri, United States

Site Status

Research Site 10001-053

Omaha, Nebraska, United States

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Research Site 10001-021

Omaha, Nebraska, United States

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Research Site 10001-112

Las Vegas, Nevada, United States

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Research Site 10001-124

Las Vegas, Nevada, United States

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Research Site 10001-060

Bridgewater, New Jersey, United States

Site Status

Research Site 10001-055

Raritan, New Jersey, United States

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Research Site 10001-054

Albany, New York, United States

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Research Site 10001-122

Binghamton, New York, United States

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Research Site 10001-128

Endwell, New York, United States

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Research Site 10001-042

New Windsor, New York, United States

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Research Site 10001-129

Poughkeepsie, New York, United States

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Research Site 10001-110

Williamsville, New York, United States

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Research Site 10001-063

Cary, North Carolina, United States

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Research Site 10001-064

Greensboro, North Carolina, United States

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Research Site 10001-145

Mooresville, North Carolina, United States

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Research Site 10001-046

Shelby, North Carolina, United States

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Research Site 10001-016

Akron, Ohio, United States

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Research Site 10001-120

Cincinnati, Ohio, United States

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Research Site 10001-154

Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Marion, Ohio, United States

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Edmond, Oklahoma, United States

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Research Site 10001-109

Wyomissing, Pennsylvania, United States

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Research Site 10001-001

Anderson, South Carolina, United States

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Research Site 10001-006

Greer, South Carolina, United States

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Research Site 10001-075.

Greer, South Carolina, United States

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Research Site 10001-111

Myrtle Beach, South Carolina, United States

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Research Site 10001-133

Pelzer, South Carolina, United States

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Research Site 10001-026

Spartanburg, South Carolina, United States

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Research Site 10001-103

Rapid City, South Dakota, United States

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Research Site 10001-146

Athens, Tennessee, United States

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Research Site 10001-130

Kingsport, Tennessee, United States

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Research Site 10001-118

Knoxville, Tennessee, United States

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Research Site 10001-100

Amarillo, Texas, United States

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Research Site 10001-087

Austin, Texas, United States

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Research Site 10001-117

Austin, Texas, United States

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Research Site 10001-009

Dallas, Texas, United States

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Research Site 10001-068

Edinburg, Texas, United States

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Research Site 10001-126

Fort Worth, Texas, United States

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Research Site 10001-031

Houston, Texas, United States

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Research Site 10001-088

Houston, Texas, United States

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Research Site 10001-091

Houston, Texas, United States

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Research Site 10001-061

Houston, Texas, United States

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Research Site 10001-032

Houston, Texas, United States

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Research Site 10001-025

Lubbock, Texas, United States

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Research Site 10001-057

New Braunfels, Texas, United States

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Research Site 10001-106

Powell, Texas, United States

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Research Site 10001-079

Round Rock, Texas, United States

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Research Site 10001-071

San Antonio, Texas, United States

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Research Site 10001-083

Schertz, Texas, United States

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Research Site 10001-149

Shavano Park, Texas, United States

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Research Site 10001-045

Tomball, Texas, United States

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Research Site 10001-005

Layton, Utah, United States

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Research Site 10001-002

Salt Lake City, Utah, United States

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Research Site 10001-052

Salt Lake City, Utah, United States

Site Status

Research Site 10001-093

Falls Church, Virginia, United States

Site Status

Research Site 10001-085

Manassas, Virginia, United States

Site Status

Research Site 10001-094

Midlothian, Virginia, United States

Site Status

Research Site 10001-023

Richmond, Virginia, United States

Site Status

Research Site 10001-029

Suffolk, Virginia, United States

Site Status

Research Site 10001-114

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Dutta S, Shah R, Singhal S, Singh S, Piparva K, Katoch CDS. A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients. Expert Opin Drug Saf. 2024 Feb;23(2):187-198. doi: 10.1080/14740338.2023.2293201. Epub 2023 Dec 19.

Reference Type DERIVED
PMID: 38063346 (View on PubMed)

Ray KK, Wright RS. Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol. Future Cardiol. 2023 Mar;19(4):175-184. doi: 10.2217/fca-2022-0133. Epub 2023 Jun 6.

Reference Type DERIVED
PMID: 37282500 (View on PubMed)

Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.

Reference Type DERIVED
PMID: 32187462 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MDCO-PCS-17-04

Identifier Type: -

Identifier Source: org_study_id

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