Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

Sponsor
The Medicines Company
Study ID
NCT03400800
Phase
PHASE3
Status
Completed

Conditions

  • ASCVD
  • Elevated Cholesterol
  • Risk Factor, Cardiovascular

Eligibility Criteria

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

Interventions

  • Inclisiran Sodium — DRUG
    Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
  • Placebo — DRUG
    Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Study Details

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents 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 an international multicenter study (non-United States).

Key Dates

Start date
Nov 1, 2017
Status verified
Aug 2020
Primary completion
Jul 31, 2019
Completion
Aug 27, 2019

Study Design

Enrollment
1,617 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran
    Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months.
  • Placebo Comparator: Saline Solution
    Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months.

Primary Outcome Measure

Percentage Change in LDL-C From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]

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