Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04765657
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • inclisiran sodium — DRUG
    Subcutaneously injected on Day 1, 90 and 270 (Core Part). Subcutaneously injected on Day 360 and every 6 months thereafter until EOS visit (Extension Part)
  • Placebo — DRUG
    Subcutaneously injected on Day 1, 90, and 270.

Study Details

A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C

Key Dates

Start date
Mar 1, 2021
Status verified
Dec 2025
Primary completion
Jun 9, 2022
Completion
Dec 28, 2026

Study Design

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

Arms

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

Primary Outcome Measure

Core: Percentage change in low- density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, Day 330 ]

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