Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody (FLOREY)

Amgen

Status and phase: Completed; Phase 3

Conditions: Primary Hyperlipidemia and Mixed Dyslipidemia

Treatments: Drug: Atorvastatin; Drug: Placebo to Evolocumab; Biological: Evolocumab; Drug: Placebo to Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02189837

FLOREY (Other Identifier)

20130194

Details and patient eligibility

About

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

Enrollment: 89 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to Atorvastatin

Drug: Placebo to Evolocumab

Atorvastatin

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo to Evolocumab

Drug: Atorvastatin

Evolocumab

Experimental group

Description:

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.

Treatment:

Drug: Placebo to Atorvastatin

Biological: Evolocumab

Evolocumab and Atorvastatin

Experimental group

Description:

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.

Treatment:

Biological: Evolocumab

Drug: Atorvastatin