Evidence map›Paper›PMID 24385236›Full record

Trial reportArteriosclerosis, thrombosis, and vascular biology2014

Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus.

Maria J Gutierrez, Noah L Rosenberg, Diane E Macdougall, Jeffrey C Hanselman, Janice R Margulies, Poul Strange, Mark A Milad, Scott J McBride, Roger S Newton

5 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Arteriosclerosis, thrombosis, and vascular biology, 2014. 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 60 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 7 pooled it
12.6field-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 23770179other papers from this trial
Open the trial in the graph
NCT03531905 phase2completedstarted 2018, after this paper: background citation

A Randomized Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 + Ezetimibe 10 Fixed-Dose Combination Compared to Ezetimibe and Placebo In Subjects With T2DM and Elevated LDL-Cholesterol

Ran2018Enrolled242Registered outcomes16Posted comparisons36ConditionsCholesterolemia, Diabetes, Diabetes Mellitus, Type 2ArmsBempedoic acid + Ezetimibe FDC Oral Tablet, Ezetimibe 10 mg Oral Tablet, Placebo Oral Capsule, Placebo Oral Tablet
Open the trial in the graph
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 map

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 map

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

60 citing papers in PubMed, 7 syntheses or guidelines pooled it, 169 citations in OpenAlex.

  1. Pooled it
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  10. Bempedoic Acid: From Guidelines to the Real World.Journal of lipid and atherosclerosis · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Maria J GutierrezFrom Comprehensive Clinical Development, Miramar, FL (M.J.G.); Esperion Therapeutics Inc, Plymouth, MI (N.L.R., D.E.M., J.C.H., J.R.M., R.S.N.); Integrated Medical Development LLC, Princeton Junction, NJ (P.S.); Milad Consulting, Plymouth, MI (M.A.M.); and United BioSource Corporation, Ann Arbor, MI (S.J.M.).
Noah L Rosenberg
Diane E Macdougall
Jeffrey C Hanselman
Janice R Margulies
Poul Strange
Mark A Milad
Scott J McBride
Roger S Newton
Comprehensive Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objective8-Hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (ETC-1002) is a small molecule with a unique mechanism of action shown in nonclinical studies to modulate pathways of cholesterol, fatty acid, and carbohydrate metabolism. In previous phase 2 clinical trials, once daily oral treatment with ETC-1002 significantly reduced low-density lipoprotein-cholesterol in patients with hypercholesterolemia. In this trial, the lipid-lowering efficacy of ETC-1002 was evaluated in patients with type 2 diabetes mellitus and hypercholesterolemia. Additional cardiometabolic biomarkers, including glycemic measures, were also assessed. APPROACH AND

resultsA single-center, double-blind, placebo-controlled trial evaluated 60 patients with type 2 diabetes mellitus and elevated low-density lipoprotein-cholesterol. Patients discontinued all diabetes mellitus and lipid-regulating drugs and were randomized to receive ETC-1002 80 mg QD for 2 weeks followed by 120 mg QD for 2 weeks or placebo for 4 weeks. ETC-1002 lowered low-density lipoprotein-cholesterol levels by 43±2.6% (least squares mean±SE), compared with a reduction of 4±2.5% by placebo at day 29 (P<0.0001; primary end point). Non-high-density lipoprotein-cholesterol and total cholesterol were also significantly lowered by ETC-1002 compared with placebo (P<0.0001). High-sensitivity C-reactive protein was reduced by 41% (median) compared with a placebo reduction of 11% (P=0.0011). No clinically meaningful safety findings were observed.

conclusionsETC-1002 lowered low-density lipoprotein-cholesterol and other lipids and demonstrated improvement in high-sensitivity C-reactive protein in patients with type 2 diabetes mellitus and hypercholesterolemia without worsening glycemic control. ETC-1002 was well tolerated in this population. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT# 01607294.

Indexed as

AgedAnticholesteremic AgentsAntihypertensive AgentsBlood GlucoseBlood PressureCholesterol, HDLCholesterol, LDLC-Reactive ProteinDiabetes Mellitus, Type 2Dicarboxylic AcidsDouble-Blind MethodFastingFatty AcidsFemaleHumansHypercholesterolemia8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidAnticholesteremic AgentsAntihypertensive AgentsBlood GlucoseCholesterol, HDLCholesterol, LDLC-Reactive ProteinDicarboxylic AcidsFatty AcidsHypoglycemic AgentsTriglyceridescardiovascular diseaseslipid and lipoprotein metabolismlow-density lipoprotein-cholesterolrisk factorstype 2 diabetes mellitus

Identifiers

PMID24385236
OpenAlexW2117644277

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.