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: Other: Placebo to Evolocumab; Biological: Evolocumab; Drug: Ezetimibe

• 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

Study Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Study Start: 2011-07-06
• Primary Completion: 2012-03-02
• Study Completion: 2012-03-02
• Disposition First Submitted: 2013-03-26
• Disposition First Submitted QC: 2013-04-02
• Disposition First Posted: 2013-04-09
• Results First Submitted: 2015-09-03
• Results First Submitted QC: 2015-09-03
• Results First Posted: 2015-10-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08

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

Trial Locations

Locations (1)

Research Site; 🇩🇰 Vejle, Denmark