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HypercholesterolemiaPhase 3CLEAR SerenityNCT02988115

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant

A Phase 3 study testing bempedoic acid in people with Hypercholesterolemia and Atherosclerotic Cardiovascular Disease, run by Esperion Therapeutics, Inc. at 67 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bempedoic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
345 participants
Where
67 sitesin 2 countries
Study dates
16 Nov 2016to 16 Mar 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)
  • Be statin-intolerant (unable to tolerate 2 or more statins)

Who cannot join

  • Total fasting triglyceride ≥500 mg/dL
  • Renal dysfunction or nephrotic syndrome or history of nephritis
  • Body Mass Index (BMI) ≥50 kg/m2
  • Significant cardiovascular disease or cardiovascular event in the past 3 months

Trial locations and contacts

67 sites in 2 countries.

67 sites in 2 countries

United States52 sites

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Beaver, Pennsylvania

  • Study site

    Binghamton, New York

  • Study site

    Clinton, Utah

  • Study site

    Columbus, Ohio

  • Study site

    Cumberland, Rhode Island

  • Site 1

    Dallas, Texas

  • Site 2

    Dallas, Texas

  • Study site

    Daytona Beach, Florida

  • Study site

    Endwell, New York

  • Study site

    Evanston, Illinois

  • Study site

    Evansville, Indiana

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Gilbert, Arizona

  • Study site

    Greensboro, North Carolina

  • Study site

    Hamden, Connecticut

  • Study site

    Hampton, Virginia

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Jackson, Tennessee

  • Study site

    Kenosha, Wisconsin

  • Study site

    Knoxville, Tennessee

  • Study site

    Langhorne, Pennsylvania

  • Study site

    Lincoln, Nebraska

  • Study site

    Long Beach, California

  • Study site

    Marion, Ohio

  • Study site

    Maumee, Ohio

  • Study site

    Memphis, Tennessee

  • Study site

    Meridian, Idaho

  • Site 1

    Miami, Florida

  • Site 2

    Miami, Florida

  • Study site

    Monroe, Louisiana

  • Study site

    Morganton, North Carolina

  • Study site

    Mount Airy, North Carolina

  • Study site

    New Windsor, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Savannah, Georgia

  • Study site

    Slidell, Louisiana

  • Study site

    Somerset, New Jersey

  • Study site

    Summerville, South Carolina

  • Study site

    Torrance, California

  • Study site

    Tupelo, Mississippi

  • Study site

    Ventura, California

  • Study site

    Waterloo, Iowa

  • Study site

    West Palm Beach, Florida

Other trials in United States

Canada15 sites

  • Study site

    Brossard

  • Study site

    Chicoutimi

  • Study site

    Gatineau

  • Study site

    London

  • Study site

    Longueuil

  • Study site

    Mirabel

  • Study site

    Montreal

  • Study site

    Newmarket

  • Study site

    Oakville

  • Study site

    Peterborough

  • Study site

    Pointe-Claire

  • Study site

    Saint-Jérôme

  • Study site

    Sarnia

  • Study site

    Toronto

  • Study site

    Victoriaville

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.

Being tested
bempedoic acid, placebo
Keywords
hyperlipidemia, cholesterol, familial hypercholesterolemia, atherosclerotic cardiovascular disease, ASCVD, HeFH, LDL, statin intolerance
Medical subject headings
Hypercholesterolemia, Atherosclerosis, Hyperlipidemias, Hyperlipoproteinemia Type II

What participants receive

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

  • bempedoic acidDrug

    Also called ETC-1002

    bempedoic acid 180 mg tablet

  • placeboOther

    Also called placebo control

    Matching placebo tablet

Study groups in NCT02988115
Study groupRoleWhat they receive
bempedoic acidExperimentalbempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Receives: Drug: bempedoic acid
placeboPlacebo comparatorMatching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Receives: Other: placebo

What is being measured

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

  1. Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

    PCFB was calculated as the ([post-Baseline (BL) value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. PCFB in LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.

    Measured: Baseline; Week 12

Secondary outcomes (4)

  1. Percent Change From Baseline in LDL-C at Week 24

    PCFB was calculated as the ([post-BL value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available then that single value was used as BL. PCFB in LDL-C was analyzed using ANCOVA, with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.

    Measured: Baseline; Week 24

  2. Percent Change From Baseline in the Lipid Profile at Week 12

    PCFB was calculated as: ([post-BL value minus the BL value] divided by the BL value) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. apoB and TC BL were defined as the last non-missing value on/prior to Day 1. PCFB was analyzed using ANCOVA, with treatment and group stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing data at Week 12 who were no longer taking study treatment (ST), missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking ST, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.

    Measured: Baseline; Week 12

  3. Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline for hsCRP is defined as the last non-missing value on or prior to Day 1. Percent change from Baseline in hsCRP, non-parametric (Wilcoxon rank-sum test) analysis with Hodges-Lehmann estimates and confidence interval was performed.

    Measured: Baseline; Week 12

  4. Absolute Change From Baseline in LDL-C at Week 12 and Week 24

    Change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the last two non-missing values on or prior to Day 1.

    Measured: Baseline; Week 12; Week 24

Timeline

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

  1. First posted9 Dec 2016 (estimated)
  2. Study start16 Nov 2016
  3. Primary completion16 Mar 2018
  4. Study completion16 Mar 2018

Resources

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, Investigator, Outcomes assessor
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02988115
Sponsor's protocol ID
1002-046
Acronym
CLEAR Serenity
Status last verified
Mar 2020
First submitted
7 Dec 2016
Last updated
3 Apr 2020
Data monitoring committee
Yes

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

  • Eckel RH. Approach to the patient who is intolerant of statin therapy. J Clin Endocrinol Metab. 2010 May;95(5):2015-22. doi: 10.1210/jc.2009-2689.

    PubMed 20444930

  • Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005 Jan 6;352(1):20-8. doi: 10.1056/NEJMoa042378.

    PubMed 15635109

  • Robinson JG, Stone NJ. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk: a new paradigm supported by more evidence. Eur Heart J. 2015 Aug 14;36(31):2110-2118. doi: 10.1093/eurheartj/ehv182. Epub 2015 May 20.

    PubMed 25994746

  • Ballantyne CM, Bays HE, Louie MJ, Smart J, Zhang Y, Ray KK. Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid. J Am Heart Assoc. 2022 Aug 2;11(15):e024531. doi: 10.1161/JAHA.121.024531. Epub 2022 Aug 2.

    PubMed 35916348

  • Banach M, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Flaim J, Ye Z, Catapano AL. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020 Oct 1;5(10):1124-1135. doi: 10.1001/jamacardio.2020.2314.

    PubMed 32609313

  • Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662.

    PubMed 30922146

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bempedoic acid in people with Hypercholesterolemia and Atherosclerotic Cardiovascular Disease, run by Esperion Therapeutics, Inc. at 67 sites in 2 countries.

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 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 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 67 sites in United States, Canada. 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 3 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 (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (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 NCT02988115, which also lists 8 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 Apr 2020.

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