A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06431763
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Inclisiran sodium — DRUG
    300 mg s.c. administered at day 1 and day 90
  • BPA — DRUG
    180 mg daily per oral

Study Details

This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020) and elevated levels of LDL-C (≥ 70 mg/dL) despite being on a maximally tolerated high-intensity (HI) statin dose (+/- Ezetimibe). Currently, BPA is recommended ahead of injectables by German HTA body (GBA). A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs. BPA and to support the early use of Inclisiran.

Key Dates

Start date
Jun 21, 2024
Status verified
Jan 2026
Primary completion
Dec 1, 2025
Completion
Jan 2, 2026

Study Design

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

Arms

  • Experimental: Inclisiran
    Inclisiran treatment on top of background treatment (high intensity statin with/without ezetimibe)
  • Active Comparator: Bempedoic acid (BPA)
    BPA treatment on top of background treatment (high intensity statin with/without ezetimibe)

Primary Outcome Measure

Percent change from baseline in LDL-C levels [ Time Frame: Baseline, Day 150 ]

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