Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody (FLOREY)
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ClinicalTrials.gov Identifier: NCT02189837 |
Recruitment Status :
Completed
First Posted : July 15, 2014
Results First Posted : August 31, 2016
Last Update Posted : October 3, 2018
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Condition or disease | Intervention/treatment | Phase |
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Primary Hyperlipidemia and Mixed Dyslipidemia | Biological: Evolocumab Drug: Atorvastatin Drug: Placebo to Evolocumab Drug: Placebo to Atorvastatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Double-blind, Randomized, Placebo-controlled, Single Site Study to Evaluate the Effects of Evolocumab (AMG 145) Treatment, Alone and in Combination With Atorvastatin, on Lipoprotein Kinetics |
Actual Study Start Date : | July 8, 2014 |
Actual Primary Completion Date : | February 13, 2015 |
Actual Study Completion Date : | March 5, 2015 |

Arm | Intervention/treatment |
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Placebo Comparator: 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.
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Drug: Placebo to Evolocumab
Administered by subcutaneous injection Drug: Placebo to Atorvastatin Administered by mouth |
Active Comparator: 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.
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Drug: Atorvastatin
Administered by mouth
Other Name: LIPITOR® Drug: Placebo to Evolocumab Administered by subcutaneous injection |
Experimental: 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.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
Drug: Placebo to Atorvastatin Administered by mouth |
Experimental: 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.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
Drug: Atorvastatin Administered by mouth
Other Name: LIPITOR® |
- Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR) [ Time Frame: Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration. ]The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
- Percent Change From Baseline in LDL-C at Day 50 [ Time Frame: Baseline and Day 50 ]LDL-C was measured using ultrcentrifugation.
- Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR) [ Time Frame: Baseline and Day 50 ]The production rate of apolipoprotein B-100 in LDL was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate the production rate.
- Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR) [ Time Frame: Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration. ]The fractional catabolic rate (the percentage of lipoprotein(a) (Lp[a]) which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
- Percent Change From Baseline in Lipoprotein(a) Production Rate (PR) [ Time Frame: Baseline and Day 50 ]The production rate of lipoprotein(a) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189837
Australia, South Australia | |
Research Site | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Western Australia | |
Research Site | |
Nedlands, Western Australia, Australia, 6009 |
Study Director: | MD | Amgen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT02189837 |
Other Study ID Numbers: |
20130194 FLOREY ( Other Identifier: Amgen ) |
First Posted: | July 15, 2014 Key Record Dates |
Results First Posted: | August 31, 2016 |
Last Update Posted: | October 3, 2018 |
Last Verified: | September 2018 |
Raised cholesterol Cholesterol Elevated Cholesterol Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
Dyslipidemias Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Evolocumab Antibodies, Monoclonal Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs |