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Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

Study acronym: LILITH
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 72 to confirmed 73
    • Study description revised
    • Study sites revised (30)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This observational, multicenter, retrospective and prospective study aims to evaluate the effect of lomitapide treatment on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). HoFH is a rare genetic disorder characterized by extremely high levels of LDL cholesterol (LDL-C), leading to an increased risk of early cardiovascular diseases. Lomitapide is an approved medication that lowers LDL-C levels by inhibiting microsomal triglyceride transfer protein (MTP). The study will collect data from patients who have been treated with lomitapide for at least 12 months and will compare the incidence of MACE during the first three years of treatment with the three years before treatment initiation. The study includes data collection from multiple lipid centers across Europe. The primary objective is to assess the impact of lomitapide on MACE, while secondary objectives include evaluating changes in lipid profiles, liver function tests, and lipid-lowering treatments.
Trial Details
NCT Number NCT06832371
Lead Sponsor Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Collaborators: Amryt Pharmaceuticals DAC, Clinical Trial Consulting, CMV-Stat S.r.l.
Conditions
(from sponsor)		 Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE), Dyslipidemia
Related terms Atherosclerosis, Cardiovascular Diseases, Dyslipidemias, Homozygous Familial Hypercholesterolemia, Hypercholesterolemia, Lipid Metabolism Disorders
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov