Primary Hyperlipidemia and Mixed DyslipidemiaPhase 3FLOREYNCT02189837

Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

A Phase 3 study testing Evolocumab and Atorvastatin in people with Primary Hyperlipidemia and Mixed Dyslipidemia, run by Amgen at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Primary Hyperlipidemia and Mixed Dyslipidemia
What is being tested?: Evolocumab and Atorvastatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 2 sitesAustralia
Study dates: 8 Jul 2014to 5 Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

Australia2 sites

Research Site
Adelaide, South Australia, 5000
Research Site
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

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

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

Conditions: Primary Hyperlipidemia and Mixed Dyslipidemia
Being tested: Evolocumab, Atorvastatin, Placebo to Evolocumab, Placebo to Atorvastatin
Keywords: Raised cholesterol, Cholesterol, Elevated Cholesterol, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
Medical subject headings: Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection
AtorvastatinDrug
Also called LIPITOR®
Administered by mouth
Placebo to EvolocumabDrug
Administered by subcutaneous injection
Placebo to AtorvastatinDrug
Administered by mouth

Study groups in NCT02189837
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo to Evolocumab; Drug: Placebo to Atorvastatin
Atorvastatin	Active comparator	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. Receives: Drug: Atorvastatin; Drug: Placebo to Evolocumab
Evolocumab	Experimental	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. Receives: Biological: Evolocumab; Drug: Placebo to Atorvastatin
Evolocumab and Atorvastatin	Experimental	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. Receives: Biological: Evolocumab; Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)
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.
Measured: 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.

Secondary outcomes (4)

Percent Change From Baseline in LDL-C at Day 50
LDL-C was measured using ultrcentrifugation.
Measured: Baseline and Day 50
Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)
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.
Measured: Baseline and Day 50
Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR)
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.
Measured: 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.
Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)
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.
Measured: Baseline and Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 20145 Mar 2015

First posted15 Jul 2014 (estimated)
Study start8 Jul 2014
Primary completion13 Feb 2015
Study completion5 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Primary Hyperlipidemia and Mixed DyslipidemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189837
Sponsor's protocol ID: 20130194
Other IDs: FLOREY
Acronym: FLOREY
Status last verified: Sep 2018
First submitted: 8 Jul 2014
Last updated: 3 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Watts GF, Chan DC, Dent R, Somaratne R, Wasserman SM, Scott R, Burrows S, R Barrett PH. Factorial Effects of Evolocumab and Atorvastatin on Lipoprotein Metabolism. Circulation. 2017 Jan 24;135(4):338-351. doi: 10.1161/CIRCULATIONAHA.116.025080. Epub 2016 Dec 9.
PubMed 27941065
Watts GF, Chan DC, Somaratne R, Wasserman SM, Scott R, Marcovina SM, Barrett PHR. Controlled study of the effect of proprotein convertase subtilisin-kexin type 9 inhibition with evolocumab on lipoprotein(a) particle kinetics. Eur Heart J. 2018 Jul 14;39(27):2577-2585. doi: 10.1093/eurheartj/ehy122.
PubMed 29566128
Chan DC, Watts GF, Somaratne R, Wasserman SM, Scott R, Barrett PHR. Comparative Effects of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibition and Statins on Postprandial Triglyceride-Rich Lipoprotein Metabolism. Arterioscler Thromb Vasc Biol. 2018 Jul;38(7):1644-1655. doi: 10.1161/ATVBAHA.118.310882. Epub 2018 Jun 7.
PubMed 29880491
Chan DC, Watts GF, Coll B, Wasserman SM, Marcovina SM, Barrett PHR. Lipoprotein(a) Particle Production as a Determinant of Plasma Lipoprotein(a) Concentration Across Varying Apolipoprotein(a) Isoform Sizes and Background Cholesterol-Lowering Therapy. J Am Heart Assoc. 2019 Apr 2;8(7):e011781. doi: 10.1161/JAHA.118.011781.
PubMed 30897995

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Hyperlipidemia and Mixed Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02189837
Acronym / sponsor ID: FLOREY / 20130194
Conditions: Primary Hyperlipidemia and Mixed Dyslipidemia
Keywords: Raised cholesterol, Cholesterol, Elevated Cholesterol, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 8 Jul 2014 (actual)
Primary completion: 13 Feb 2015 (actual)
Study completion: 5 Mar 2015 (actual)
First posted: 15 Jul 2014 (estimated)
Results: Posted 31 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo to Evolocumab, Drug: Placebo to AtorvastatinParticipants 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.
Atorvastatin	Active comparator	Drug: Atorvastatin, Drug: Placebo to EvolocumabParticipants 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.
Evolocumab	Experimental	Biological: Evolocumab, Drug: Placebo to AtorvastatinParticipants 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.
Evolocumab and Atorvastatin	Experimental	Biological: Evolocumab, Drug: AtorvastatinParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection	Biological	Evolocumab, Evolocumab and Atorvastatin
AtorvastatinAlso: LIPITOR®Administered by mouth	Drug	Atorvastatin, Evolocumab and Atorvastatin
Placebo to EvolocumabAdministered by subcutaneous injection	Drug	Atorvastatin, Placebo
Placebo to AtorvastatinAdministered by mouth	Drug	Evolocumab, Placebo

Primary outcome

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.

4 secondary outcomes

Percent Change From Baseline in LDL-C at Day 50
Time frame: Baseline and Day 50
Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)
Time frame: Baseline and Day 50
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.
Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)
Time frame: Baseline and Day 50

Results and safety

Results posted to the registry on 31 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	22	20
Atorvastatin	23	22
Evolocumab	23	20
Evolocumab and Atorvastatin	21	19

Primary outcome: 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.. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo n = 20	Atorvastatin n = 22	Evolocumab n = 20	Evolocumab and Atorvastatin n = 19
Value	-5.07 (26.06)	74.13 (24.84)	83.70 (26.06)	310.48 (26.68)

Placebo vs Evolocumab: LS Mean Treatment Difference: 88.76 (95% CI 15.73 to 161.80), p = 0.018, ANCOVA
Atorvastatin vs Evolocumab and Atorvastatin: LS Mean Treatment Difference: 236.35 (95% CI 164.02 to 308.69), p <0.001, ANCOVA
Placebo vs Atorvastatin vs Evolocumab vs Evolocumab and Atorvastatin: Treatment Effect: 147.59 (95% CI 44.80 to 250.38), p = 0.005, ANCOVA

Population analysed: Efficacy Analysis Set including all randomized and dosed participants who completed baseline and Day 50 measurements.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug until day 73. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	5 of 21 (23.8%)	Not reported
Atorvastatin	0 of 22 (0%)	12 of 22 (54.5%)	Not reported
Evolocumab	0 of 22 (0%)	14 of 22 (63.6%)	Not reported
Evolocumab and Atorvastatin	1 of 20 (5%)	10 of 20 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27941065Watts GF, Chan DC, Dent R, Somaratne R, Wasserman SM, Scott R, Burrows S, R Barrett PH. Factorial Effects of Evolocumab and Atorvastatin on Lipoprotein Metabolism. Circulation. 2017 Jan 24;135(4):338-351. doi: 10.1161/CIRCULATIONAHA.116.025080. Epub 2016 Dec 9.
Background: PubMed 29566128Watts GF, Chan DC, Somaratne R, Wasserman SM, Scott R, Marcovina SM, Barrett PHR. Controlled study of the effect of proprotein convertase subtilisin-kexin type 9 inhibition with evolocumab on lipoprotein(a) particle kinetics. Eur Heart J. 2018 Jul 14;39(27):2577-2585. doi: 10.1093/eurheartj/ehy122.
Background: PubMed 29880491Chan DC, Watts GF, Somaratne R, Wasserman SM, Scott R, Barrett PHR. Comparative Effects of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibition and Statins on Postprandial Triglyceride-Rich Lipoprotein Metabolism. Arterioscler Thromb Vasc Biol. 2018 Jul;38(7):1644-1655. doi: 10.1161/ATVBAHA.118.310882. Epub 2018 Jun 7.
Derived from this study: PubMed 30897995Chan DC, Watts GF, Coll B, Wasserman SM, Marcovina SM, Barrett PHR. Lipoprotein(a) Particle Production as a Determinant of Plasma Lipoprotein(a) Concentration Across Varying Apolipoprotein(a) Isoform Sizes and Background Cholesterol-Lowering Therapy. J Am Heart Assoc. 2019 Apr 2;8(7):e011781. doi: 10.1161/JAHA.118.011781.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Primary Hyperlipidemia and Mixed Dyslipidemia

Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab and Atorvastatin in people with Primary Hyperlipidemia and Mixed Dyslipidemia, run by Amgen at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189837, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.