A study in which patients will be assigned, by chance, to receive either the active drug Evinacumab or a dummy-drug, (a placebo), without anybody knowing what that are assigned to, to determine safety and efficacy of different dose regimens of Evinacumab in patients with persistent high cholesterol despite taking the maximum tolerated lipid modifying therapy
- Conditions
- Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying TherapyMedDRA version: 21.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2017-001508-31-CZ
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 266
1. Men and women, ages 18 through 80 at the screening visit
2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
3. A history of clinical ASCVD, for those patients who are non-HeFH.
4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
5. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit
6. Serum LDL-C = 100 mg/dL at screening (1 repeat lab is allowed)
7. Provide signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. Known history of homozygous FH (clinically, or by previous genotyping)
2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
3. Newly diagnosed diabetes (within 3 months prior to screening)
4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)
5. Laboratory findings during screening period (not including randomization labs):
- Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus
- Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)
- Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential
- Estimated glomerular filtration rate < 30 mL/min/1.73 m^2
- TSH > 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
- Creatine phosphokinase (CPK) > 3 x ULN at screening (1 repeat lab is allowed)
6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization
7. History of heart failure (New York Heart Association [NYHA] Class II-IV) within 12 months before screening
8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening
9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)
10. Having received LDL apheresis within 2 months before screening
11. Pregnant or breast-feeding women
12. Women of childbearing potential who are unwilling to practice a highly effective birth control method
13. Sexually active men unwilling to use acceptable birth control
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method