Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05888103
Phase
PHASE3
Status
Completed

Conditions

  • Primary Hypercholesterolemia or Mixed Dyslipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.

Key Dates

Start date
Jul 11, 2023
Status verified
Dec 2025
Primary completion
Apr 2, 2024
Completion
Oct 24, 2024

Study Design

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

Arms

  • Experimental: Inclisiran - Inclisiran
    Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Day 1, Day 90, and Day 270, and placebo on Day 180
  • Placebo Comparator: Placebo- Inclisiran
    Placebo on Day 1 and Day 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c on Day 180 and 270

Primary Outcome Measure

Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part [ Time Frame: Baseline, Day 150 ]

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