An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03060577
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran — DRUG
    Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
  • Evolocumab — DRUG
    Evolocumab is a fully human monoclonal antibody that inhibits PCSK9.

Study Details

This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).

Key Dates

Start date
Apr 27, 2017
Status verified
Feb 2023
Primary completion
Dec 17, 2021
Completion
Dec 17, 2021

Study Design

Enrollment
382 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran-only
    Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter for up to 4 years.
  • Active Comparator: Switching
    Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter for up to 4 years.

Primary Outcome Measure

Percentage Change in LDL-C From Baseline of the ORION-1 Study to Day 210 in ORION-3 (Inclisiran Arm) [ Time Frame: Baseline (ORION-1) and Day 210 (ORION-3) (up to 570 days total) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteJacksonvilleFlorida32216-
Novartis Investigative SiteIndianapolisIndiana46260-
Novartis Investigative SiteNew YorkNew York10029-
Novartis Investigative SiteCincinnatiOhio45229-
Novartis Investigative SiteCincinnatiOhio45246-
Novartis Investigative SiteGreenvilleTennessee37745-
Novartis Investigative SiteAmarilloTexas79106-
Novartis Investigative SiteRichmondVirginia23294-

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Novartis Investigative Site· Jacksonville, FLNovartis Investigative Site· Indianapolis, INNovartis Investigative Site· New York, NYNovartis Investigative Site· Cincinnati, OHNovartis Investigative Site· Greenville, TNNovartis Investigative Site· Amarillo, TX

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