HyperlipidemiasPhase 3NCT03337308

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

A Phase 3 study testing Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid and Ezetimibe in people with Hyperlipidemias, run by Esperion Therapeutics, Inc. at 5 sites in United States.

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

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperlipidemias
What is being tested?: Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid and Ezetimibe
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 382 participants
Where: 5 sitesUnited States
Study dates: 23 Oct 2017to 18 Jul 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Who cannot join

Total Fasting Triglyceride ≥ 400 mg/dL
Renal Dysfunction or nephrotic syndrome or history of nephritis
Significant cardiovascular disease or cardiovascular event within the past 3 months

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

PMG Research of McFarland
Ames, Iowa, 50010
PMG Research of Knoxville
Knoxville, Tennessee, 37912
Foundation Cardiology
Nashua, New Hampshire, 03060
PMG Research of Piedmont Healthcare
Statesville, North Carolina, 28625
PMG Research of Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy

Conditions: Hyperlipidemias
Being tested: Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, Ezetimibe, Placebos
Keywords: hyperlipidemia, heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease, high cholesterol, ASCVD, HeFH, LDL
Medical subject headings: Hyperlipidemias, Atherosclerosis, Hypercholesterolemia

What participants receive

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

Bempedoic Acid + Ezetimibe Fixed-Dose CombinationCombination product
Also called Bempedoic Acid + Zetia FDC, ETC-1002 + Zetia
bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
Bempedoic AcidDrug
Also called ETC-1002
bempedoic acid 180 mg tablet
EzetimibeDrug
Also called Zetia
ezetimibe 10 mg overencapsulated tablet
PlacebosDrug
Also called Placebo
placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule

Study groups in NCT03337308
Study group	Role	What they receive
BA 180 mg + EZE 10 mg FDC	Experimental	Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks Receives: Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination; Drug: Placebos
BA 180 mg	Experimental	Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks Receives: Drug: Bempedoic Acid; Drug: Placebos
EZE 10 mg	Active comparator	Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks Receives: Drug: Ezetimibe; Drug: Placebos
Placebos	Placebo comparator	Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks Receives: Drug: Placebos

What is being measured

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

Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.
Measured: Baseline; Week 12

Secondary outcomes (6)

Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
Measured: Baseline; Week 12
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
Measured: Baseline; Week 12
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
Measured: Baseline; Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
Measured: Baseline; Week 12
Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
Measured: Baseline; Week 12
Percent Change From Baseline to Week 12 in Triglycerides (TGs)
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([TGs value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
Measured: Baseline; Week 12

Timeline

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

23 Oct 201718 Jul 2018

First posted8 Nov 2017
Study start23 Oct 2017
Primary completion18 Jun 2018
Study completion18 Jul 2018

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 (6)Papers the sponsor has linked to this study.
Other trials for HyperlipidemiasStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03337308
Sponsor's protocol ID: 1002FDC-053
Status last verified: Mar 2020
First submitted: 6 Nov 2017
Last updated: 8 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
PubMed 27892461
Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
PubMed 21067804
Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.
PubMed 27594540
Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985.
PubMed 27673306
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
PubMed 24222016
Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29.
PubMed 31357887

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 Hyperlipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy
ClinicalTrials.gov ID: NCT03337308
Acronym / sponsor ID: 1002FDC-053
Conditions: Hyperlipidemias
Keywords: hyperlipidemia, heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease, high cholesterol, ASCVD, HeFH, LDL
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 382 participants (actual)
Lead sponsor: Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 23 Oct 2017 (actual)
Primary completion: 18 Jun 2018 (actual)
Study completion: 18 Jul 2018 (actual)
First posted: 8 Nov 2017 (actual)
Results: Posted 8 Apr 2020

Clinical summary

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

Study design

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

Arm	Type	Receives
BA 180 mg + EZE 10 mg FDC	Experimental	Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Drug: PlacebosBempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks
BA 180 mg	Experimental	Drug: Bempedoic Acid, Drug: PlacebosBempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks
EZE 10 mg	Active comparator	Drug: Ezetimibe, Drug: PlacebosEzetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks
Placebos	Placebo comparator	Drug: PlacebosPlacebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Key exclusion criteria (3 listed)

Total Fasting Triglyceride ≥ 400 mg/dL
Renal Dysfunction or nephrotic syndrome or history of nephritis
Significant cardiovascular disease or cardiovascular event within the past 3 months

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
Bempedoic Acid + Ezetimibe Fixed-Dose CombinationAlso: Bempedoic Acid + Zetia FDC, ETC-1002 + Zetiabempedoic acid + ezetimibe FDC 180 mg/10 mg tablet	Combination product	BA 180 mg + EZE 10 mg FDC
Bempedoic AcidAlso: ETC-1002bempedoic acid 180 mg tablet	Drug	BA 180 mg
EzetimibeAlso: Zetiaezetimibe 10 mg overencapsulated tablet	Drug	EZE 10 mg
PlacebosAlso: Placeboplacebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule	Drug	BA 180 mg, BA 180 mg + EZE 10 mg FDC, EZE 10 mg, Placebos

Primary outcome

Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline; Week 12
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.

6 secondary outcomes

Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Triglycerides (TGs)
Time frame: Baseline; Week 12

Results and safety

Results posted to the registry on 8 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC	108	103
Bempedoic Acid 180 mg	110	103
Ezetimibe 10 mg	109	104
Placebo	55	53

Primary outcome: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)

Time frame: Baseline; Week 12. Least squares mean (Standard Error). Unit: Percent Change

Measure	Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC n = 86	Bempedoic Acid 180 mg n = 88	Ezetimibe 10 mg n = 86	Placebo n = 41
Value	-36.2 (2.56)	-17.2 (2.52)	-23.2 (2.18)	1.8 (3.49)

Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo: Difference of Least Squares (LS) means: -38.0 (95% CI -46.5 to -29.6), p <0.001, ANCOVA
Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Bempedoic Acid 180 mg: Difference of LS means: -19.0 (95% CI -26.1 to -11.9), p <0.001, ANCOVA
Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Ezetimibe 10 mg: Difference of LS means: -13.1 (95% CI -19.7 to -6.5), p <0.001, ANCOVA

Population analysed: Full Analysis Set (FAS), also known as the intention-to-treat set, was defined as all randomized participants. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 14 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC	8 of 107 (7.5%)	26 of 107 (24.3%)	0 of 107
Bempedoic Acid 180 mg	7 of 110 (6.4%)	27 of 110 (24.5%)	0 of 110
Ezetimibe 10 mg	10 of 109 (9.2%)	26 of 109 (23.9%)	0 of 109
Placebo	1 of 55 (1.8%)	12 of 55 (21.8%)	0 of 55

Limitations and caveats (from the sponsor): After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27892461Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
Background: PubMed 21067804Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
Background: PubMed 27594540Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.
Background: PubMed 27673306Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985.
Background: PubMed 24222016Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
Derived from this study: PubMed 31357887Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29.

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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.

Ron Haberman, MD study director

Esperion Therapeutics, Inc.

5 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 Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid and Ezetimibe in people with Hyperlipidemias, run by Esperion Therapeutics, Inc. at 5 sites in United States.

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 3 inclusion and 3 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 8 Apr 2020). 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 to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) (time frame: Baseline; Week 12). 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 NCT03337308, which also lists 6 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 8 Apr 2020.