Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels (MENDEL)
Status and phase
Completed
Phase 2
Conditions
Hyperlipidemia
Treatments
Drug: Ezetimibe
Biological: Evolocumab
Other: Placebo to Evolocumab
Details and patient eligibility
About
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Enrollment
411 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male or female ≥ 18 to ≤ 75 years of age
- Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
- Framingham risk score of 10% or less
- Fasting triglycerides < 400 mg/dL
Exclusion criteria
- History of coronary heart disease
- New York Heart Association (NYHA) II - IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
411 participants in 9 patient groups, including a placebo group
Placebo Q2W
Placebo Comparator group
Description:
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Treatment:
Other: Placebo to Evolocumab
Placebo Q4W
Placebo Comparator group
Description:
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Treatment:
Other: Placebo to Evolocumab
Ezetimibe
Active Comparator group
Description:
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
Treatment:
Drug: Ezetimibe
Evolocumab 70 mg Q2W
Experimental group
Description:
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Treatment:
Biological: Evolocumab
Evolocumab 105 mg Q2W
Experimental group
Description:
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Treatment:
Biological: Evolocumab
Evolocumab 140 mg Q2W
Experimental group
Description:
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Treatment:
Biological: Evolocumab
Evolocumab 280 mg Q4W
Experimental group
Description:
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Treatment:
Biological: Evolocumab
Evolocumab 350 mg Q4W
Experimental group
Description:
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Treatment:
Biological: Evolocumab
Evolocumab 420 mg Q4W
Experimental group
Description:
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Treatment:
Biological: Evolocumab
Trial contacts and locations
58
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Data sourced from clinicaltrials.gov
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