Primary Hypercholesterolemia MedDRA version: 20.0 Level: PT Classification code 10077965 Term: Primary hypercholesterolaemia System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must meet all of the following criteria at screening: 1. Signed informed consent must be obtained prior to participation in the study 2. Adults = 18 to = 75 years of age 3. Fasting LDL-C value of = 100 mg/dL (equivalent to 2.59 mmol/L) but =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: ? Use of any LLT within 90 days of screening including statins, ezetimibe, bempedoic acid, psyllium preparations, fibrates, bile-acid sequestrants, PCSK9 monoclonal antibodies, red yeast rice, niacin > 200 mg/day, omega-3 fatty acids [docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA), with a total dose > 1000 mg/day], or any drug with unknown ingredients taken for the purpose of lipid-lowering, including over-the-counter or herbal therapies ? Use of systemic cyclosporine or tacrolimus, systemic steroids, vitamin A derivatives or retinal derivatives for the treatment of dermatologic conditions (vitamin A in a multivitamin preparation is permitted), or antiviral therapies (protease inhibitors or direct acting antivirals) within 30 days of screening ? Participants on medications that are known to induce changes in lipids and lipoproteins (including but not limited to anticoagulants, loop diuretics, thiazide diuretics, beta blockers, amiodarone, estrogens, selective estrogen receptor modulators, androgens, anabolic steroids, and anticonvulsants) unless they are on a stable dose of such medications for at least 30 days prior to screening and have no planned dose change or treatment discontinuation during the study duration ? History of ASCVD (including acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, and peripheral artery disease including aortic aneurysm) ? Diabetes mellitus or fasting plasma glucose (FPG) at screening = 7.0 mmol/L (equivalent to 126 mg/dL) or glycated hemoglobin (HbA1c) = 6.5% (equivalent to 7.8 mmol/L or 140 mg/dL) ? Secondary hypercholesterolemia, e.g., hypothyroidism [thyroid stimulating hormone (TSH) above the upper limit of normal (ULN)] or nephrotic syndrome at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of inclisiran as monotherapy, compared with placebo, in reducing low-density lipoprotein cholesterol (LDL-C) as measured by percentage change from baseline to Day 150 & To demonstrate the superiority of inclisiran as monotherapy, compared with ezetimibe, in reducing LDL-C as measured by percentage change from baseline to Day 150;Secondary Objective: To assess the efficacy of inclisiran as monotherapy, compared to ezetimibe and placebo, on absolute change in LDL-C, percentage change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC)/high -density lipoprotein cholesterol (HDL-C) ratio, apolipoprotein B (Apo B), Apo B/apolipoprotein A-1 (Apo A-1) ratio and lipoprotein (a) (Lp(a)) from baseline to Day 150. To assess the safety and tolerability of inclisiran as monotherapy, compared to placebo and ezetimibe.;Primary end point(s): Percentage change in LDL-C from baseline to Day 150; Percentage change in LDL-C from baseline to Day 150;Timepoint(s) of evaluation of this end point: Day 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Absolute change in LDL-C, percentage change in PCSK9, non-HDL-C, TC/HDL-C ratio, Apo B, Apo B/Apo A-1 ratio and Lp (a) from baseline to Day 150. Incidence of TEAEs and SAEs, safety laboratory values at each visit.;Timepoint(s) of evaluation of this end point: Day 150 | — |
Countries
Colombia, Germany, Hungary, Mexico, Spain, United States
Contacts
Public ContactPublic Information Desk
Novartis Hungary Kft.
Outcome results
None listed