Evidence map›Paper›PMID 23770179›Full record

Trial reportJournal of the American College of Cardiology2013

Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.

Christie M Ballantyne, Michael H Davidson, Diane E Macdougall, Harold E Bays, Lorenzo A Dicarlo, Noah L Rosenberg, Janice Margulies, Roger S Newton

5 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 57 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 8 pooled it
11.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02659397 phase2completedstarted 2015, after this paper: background citation

A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients

Ran2015Enrolled68Registered outcomes8Posted comparisons0ConditionsHyperlipidemiaArmsAtorvastatin, ETC-1002, Placebo
PMID 26073387PMID 25463109PMID 24978142PMID 24385236other papers from this trial
Open the trial in the graph
NCT01262638 phase2completednot on this map

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2010 to 2011Enrolled177ConditionsDyslipidemiaArmsETC-1002, Placebo
NCT01941836 phase2completednot on this map

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2013 to 2014Enrolled349ConditionsHypercholesterolemiaArmsETC-1002, Ezetimibe
NCT02072161 phase2completednot on this mapstarted 2014, after this paper: background citation

A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients With Hypercholesterolemia Receiving Ongoing Statin Therapy

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2014 to 2015Enrolled133ConditionsHypercholesterolemiaArmsETC-1002, Placebo, Statin Therapy
NCT02178098 phase2completednot on this mapstarted 2014, after this paper: background citation

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2014 to 2015Enrolled143ConditionsHypercholesterolemia, HypertensionArmsETC-1002, Placebo
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 8 syntheses or guidelines pooled it, 173 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Bempedoic Acid: From Guidelines to the Real World.Journal of lipid and atherosclerosis · 2026
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Christie M BallantyneDepartment of Medicine, Baylor College of Medicine, Houston, Texas; Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, Texas. Electronic address: cmb@bcm.edu.
Michael H Davidson
Diane E Macdougall
Harold E Bays
Lorenzo A Dicarlo
Noah L Rosenberg
Janice Margulies
Roger S Newton
Esperion Therapeutics (United States) · USHouston Methodist · USLouisville Metabolic and Atherosclerosis Research Center · USUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to assess the lipid-altering efficacy and safety of ETC-1002 in subjects with hypercholesterolemia.

backgroundETC-1002 is a small molecule that modulates pathways of cholesterol, fatty acid, and carbohydrate metabolism and may have therapeutic benefits in treating hypercholesterolemia and other cardiometabolic risk factors.

methodsThis multicenter, randomized, double-blind, placebo-controlled, parallel-group trial evaluated patients (n = 177) with elevated low-density lipoprotein cholesterol (LDL-C) (130 to 220 mg/dl), who were stratified by baseline triglycerides (not elevated [<150 mg/dl] or elevated [150-<400 mg/dl]) and randomized to receive 40, 80, or 120 mg of ETC-1002 or placebo once daily for 12 weeks. Outcomes included changes in LDL-C (primary endpoint), other lipids, and cardiometabolic risk factors; and safety.

resultsETC-1002 40, 80, and 120 mg lowered least-squares mean ± SE LDL-C levels by 17.9 ± 2.2%, 25.0 ± 2.1%, and 26.6 ± 2.2%, respectively, versus a reduction of 2.1 ± 2.2% with placebo (all, p < 0.0001); LDL-C lowering was similar between the subgroups with nonelevated and elevated triglycerides. ETC-1002 also lowered non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B, and LDL particle number (all, p < 0.0001) in a dose-dependent manner; HDL-C and triglyceride levels were relatively unchanged. Post-hoc analyses suggest that ETC-1002 may have favorable effects on other cardiometabolic risk factors. The ETC-1002 and placebo groups did not demonstrate clinically meaningful differences in adverse events or other safety assessments.

conclusionsETC-1002 significantly lowered LDL-C levels up to 27% across a broad range of baseline triglycerides and was generally safe and well tolerated. ETC-1002 has a novel mechanism of action and may be useful for reducing LDL-C. (A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides; NCT01262638).

Indexed as

AgedAMP-Activated Protein KinasesATP Citrate (pro-S)-LyaseDicarboxylic AcidsDouble-Blind MethodFatty AcidsFemaleHumansHypercholesterolemiaHypolipidemic AgentsMaleMiddle AgedRisk Factors8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidAMP-Activated Protein KinasesATP Citrate (pro-S)-LyaseDicarboxylic AcidsFatty AcidsHypolipidemic AgentsACLadenosine monophosphate-activated protein kinaseadenosine triphosphate-citrate lyaseAMPKapoapolipoproteincardiovascular diseaseHDL-Chigh-density lipoprotein cholesterolhigh-sensitivity C-reactive proteinhsCRPLDL-Clow-density lipoprotein cholesterolmITTmodified intent-to-treatpreventionrisk factorsULNupper limit of normal

Identifiers

PMID23770179
OpenAlexW201469966

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.