Effects of Evolocumab Versus Placebo Added to Standard Lipid-lowering Therapy on Fasting and Post… (NCT03811223) | Clinical Trial Compass
UnknownPhase 4
Effects of Evolocumab Versus Placebo Added to Standard Lipid-lowering Therapy on Fasting and Post Fat Load Lipids in Patients With Familial Dysbetalipoproteinemia
30 participantsStarted 2019-08
Plain-language summary
Patients with familial dysbetalipoproteinemia (FD) have increased triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), beta VLDL, premature atherosclerosis and cardiovascular disease. They also have a delayed postprandial triglyceride and chylomicron (CM) remnant clearance. Postprandial hypertriglyceridemia is associated with increased vascular risk. Although combination therapy with statin and fibrate is recommended in the treatment of patients with FD, there is still a substantial amount of patient who do not reach their treatment target with this medication. Furthermore no information is available about the postprandial effects of adding evocolumab to standard lipid lowering therapy in FD patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients diagnosed with Familial Dysbetalipoproteinemia;
✓. \>18 years old (on the day of signing informed consent).
✓. Women are postmenopausal and not receiving hormone therapy (including cyclic and non-cyclical hormone replacement therapy or any estrogen antagonist/agonist). Postmenopausal status is defined as:
✓. Willingness to maintain a stable diet for the duration of the study.
✓. Understanding of the study procedures, alternative treatments available, and risks involved with the study and voluntarily agreement to participate by giving written informed consent.
Exclusion criteria
✕. Intolerance, known allergy or hypersensitivity to evolocumab (or other PCSK-9 monoclonal antibodies), latex or any of the components of the medication.
✕. Current or prior exposure to evolocumab or another PCSK9-inhibitor mAb in the past 12 weeks.
✕. Unable or unwilling to drink an oral fat load.
✕. Uncontrolled diabetes as defined by a HbA1c \>69 mmol/mol.
✕. BMI \>40 kg/m2.
✕. Uncontrolled blood pressure with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg.
✕. Increased hepatic enzymes, defined as alanine transaminase (ALAT) or aspartate transaminase (ASAT) \>3 times the ULN, or active liver disease defined as non alcoholic steatohepatitis (NASH), cirrhosis or Child Pugh B and C, or history of chronic active hepatitis B or C; subjects with documented resolution after treatment are permitted.