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Efficacy and Safety of a Novel Dual Modulator of Adenosine Triphosphate-Citrate Lyase and Adenosine Monophosphate-Activated Protein Kinase in Patients With Hypercholesterolemia
Open accessAbstract
Objectives The aim of this study was to assess the lipid-altering efficacy and safety of ETC-1002 in subjects with hypercholesterolemia. Background ETC-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. Methods This 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 [ Results ETC-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 Conclusions ETC-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).
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“The overall risk of bias was low 7 of 11 trials [7, 9–12, 15, 16], with 4 trials being assessed as having a moderate risk of bias [8, 13, 14, 17].”
From The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials (2024) · cites this paper as [14]
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Metadata
- Authors
- Ballantyne, C. M., Davidson, M. H., MacDougall, D. E., Bays, H. E., DiCarlo, L. A., Rosenberg, N. L., Margulies, J., & Newton, R. S.
- Affiliations
- Houston Methodist (US)
- University of Chicago (US)
- Esperion Therapeutics (United States) (US)
- Louisville Metabolic and Atherosclerosis Research Center (US)
- Corresponding author
- Ballantyne, Christie M.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2013-09
- Volume
- 62
- Issue
- 13
- Pages
- 1154-1162
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W201469966
- Semantic Scholar
- 65747388e68ae65eab0dfc122080ea1ceeab19d5
- Cited by
- 175
- References
- 27
- Citations by year
- 2026: 6 · 2025: 4 · 2024: 15 · 2023: 17 · 2022: 14 · 2021: 18 · 2020: 26 · 2019: 14 · 2018: 13 · 2017: 7 · 2016: 19 · 2015: 10 · 2014: 10 · 2013: 2
- FWCI
- 13.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Heart Association
- Amgen
- Bristol-Myers Squibb
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Amarin Corporation
- Esperion Therapeutics
- National Institutes of Health
- U.S. Food and Drug Administration
- Genentech
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Keywords
- hypercholesterolemia, LDL cholesterol lowering, ATP citrate lyase, AMPK, lipid-lowering therapy, non-HDL cholesterol, apolipoprotein B, LDL particle number, triglycerides, cardiometabolic risk factors, drug safety and tolerability, dose-response relationship, statin-resistant hypercholesterolemia
- MeSH terms
- Aged, Hypolipidemic Agents, ATP Citrate (pro-S)-Lyase, Dicarboxylic Acids, Double-Blind Method, Fatty Acids, Female, Humans, Hypercholesterolemia, Male, Middle Aged, Risk Factors, AMP-Activated Protein Kinases
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