Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-08

Study Completion Date

2015-03-05

Brief Summary

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This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

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Detailed Description

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Conditions

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Primary Hyperlipidemia and Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo to Evolocumab

Intervention Type DRUG

Administered by subcutaneous injection

Placebo to Atorvastatin

Intervention Type DRUG

Administered by mouth

Atorvastatin

Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Administered by mouth

Placebo to Evolocumab

Intervention Type DRUG

Administered by subcutaneous injection

Evolocumab

Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Placebo to Atorvastatin

Intervention Type DRUG

Administered by mouth

Evolocumab and Atorvastatin

Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Atorvastatin

Intervention Type DRUG

Administered by mouth

Interventions

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Evolocumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Atorvastatin

Administered by mouth

Intervention Type DRUG

Placebo to Evolocumab

Administered by subcutaneous injection

Intervention Type DRUG

Placebo to Atorvastatin

Administered by mouth

Intervention Type DRUG

Other Intervention Names

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AMG 145 Repatha LIPITOR®

Eligibility Criteria

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Inclusion Criteria

* Fasting LDL-C at screening ≥ 100 mg/dL and ≤ 190 mg/dL
* Fasting triglycerides ≤ 150 mg/dL
* Body mass index (BMI) between 18.0 and 32.0 kg/m\^2
* Framingham cardiac risk score 10% or less

Exclusion Criteria

* Treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening
* History of coronary heart disease (CHD) or CHD equivalent
* Uncontrolled hypertension
* Diabetes mellitus

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes