Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04666298
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Inclisiran sodium — DRUG
    Subcutaneously injected on Day 1, 90 and 270.
  • Placebo — DRUG
    Subcutaneously injected on Day 1, 90, and 270.

Study Details

This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

Key Dates

Start date
Jan 29, 2021
Status verified
Jun 2024
Primary completion
Apr 18, 2022
Completion
Oct 19, 2022

Study Design

Enrollment
312 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 300 mg inclisiran sodium
    Subcutaneous injection
  • Experimental: 200 mg inclisiran sodium
    Subcutaneous injection
  • Experimental: 100 mg inclisiran sodium
    Subcutaneous injection
  • Placebo Comparator: Placebo
    Subcutaneous injection

Primary Outcome Measure

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 [ Time Frame: Baseline, Day 180 ]

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