Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Phase 2
Completed
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT01375777
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 411
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Q2W Placebo to Evolocumab Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. Placebo Q4W Placebo to Evolocumab Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. Evolocumab 70 mg Q2W Evolocumab Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Evolocumab 105 mg Q2W Evolocumab Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Evolocumab 140 mg Q2W Evolocumab Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Evolocumab 280 mg Q4W Evolocumab Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Evolocumab 350 mg Q4W Evolocumab Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Evolocumab 420 mg Q4W Evolocumab Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Ezetimibe Ezetimibe Participants received 10 mg ezetimibe orally once a day for 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 LDL-C was measured using ultracentrifugation.
- Secondary Outcome Measures
Name Time Method Change From Baseline in LDL-C at Week 12 Baseline and Week 12 LDL-C was measured using ultracentrifugation.
Percent Change From Baseline in Apolipoprotein B at Week 12 Baseline and Week 12 Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 Baseline and Week 12 Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 Baseline and Week 12 Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 Baseline and Week 12
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the molecular mechanism of evolocumab in PCSK9 inhibition for hypercholesterolemia?
How does evolocumab compare to ezetimibe in reducing LDL-C in patients with low Framingham risk?
Which biomarkers correlate with LDL-C response to PCSK9 inhibitors like evolocumab in clinical trials?
What are the known adverse events associated with evolocumab monotherapy in phase 2 trials?
What are the current combination therapies involving PCSK9 inhibitors and ezetimibe for hyperlipidemia?
Trial Locations
- Locations (1)
Research Site
🇩🇰Vejle, Denmark
Research Site🇩🇰Vejle, Denmark