Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05192941
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran Sodium — DRUG
    Subcutaneously injected on Day 1, Day 90, and Day 270
  • Placebo — DRUG
    Placebo to inclisiran 300 mg subcutaneously

Study Details

Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

Key Dates

Start date
Apr 8, 2022
Status verified
Mar 2026
Primary completion
Jun 11, 2024
Completion
Mar 19, 2025

Study Design

Enrollment
1,770 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran
    Inclisiran sodium 300 mg s.c. + open label rosuvastatin Open label study treatment rosuvastatin: participants receive an individually optimized rosuvastatin therapy for reaching the individual LDL-C target and tolerability
  • Placebo Comparator: Placebo
    Corresponding placebo + open label rosuvastatin Open label study treatment rosuvastatin: participants receive an individually optimized rosuvastatin therapy for reaching the individual LDL-C target and tolerability

Primary Outcome Measure

Number of Participants Achieving Individual LDL-C Target (<55 mg/dL or <70 mg/dL) [ Time Frame: Day 90 ]

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