{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T14:34:31Z","timestamp":1790087671240,"version":"4.0.1"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["ATVB"],"published-print":{"date-parts":[[2014,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective\u2014<\/jats:title>\n                    <jats:p>8-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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Approach and Results\u2014<\/jats:title>\n                    <jats:p>\n                      A 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\u00b12.6% (least squares mean\u00b1SE), compared with a reduction of 4\u00b12.5% by placebo at day 29 (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.0001; primary end point). Non\u2013high-density lipoprotein-cholesterol and total cholesterol were also significantly lowered by ETC-1002 compared with placebo (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.0001). High-sensitivity C-reactive protein was reduced by 41% (median) compared with a placebo reduction of 11% (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.0011). No clinically meaningful safety findings were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\u2014<\/jats:title>\n                    <jats:p>ETC-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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration\u2014<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      . Unique identifier: NCT# 01607294.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/atvbaha.113.302677","type":"journal-article","created":{"date-parts":[[2014,1,2]],"date-time":"2014-01-02T20:47:50Z","timestamp":1388695670000},"page":"676-683","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":152,"title":["Efficacy and Safety of ETC-1002, a Novel Investigational Low-Density Lipoprotein-Cholesterol\u2013Lowering Therapy for the Treatment of Patients With Hypercholesterolemia and Type 2 Diabetes Mellitus"],"prefix":"10.1161","volume":"34","author":[{"given":"Maria J.","family":"Gutierrez","sequence":"first","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah L.","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane E.","family":"MacDougall","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey C.","family":"Hanselman","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice R.","family":"Margulies","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Poul","family":"Strange","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A.","family":"Milad","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott J.","family":"McBride","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger S.","family":"Newton","sequence":"additional","affiliation":[{"name":"From 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.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_5_2_2","volume-title":"Diabetes Report Card 2012","author":"Center for Disease","year":"2012","unstructured":"Center for Disease Control and Prevention. 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Abstract# 25085."},{"key":"e_1_3_5_18_2","volume-title":"ETC-1002 Reduces Circulating and Hepatic Triglyceride Content and Improves Glycemic Control in KKAy Mice","author":"Hanselman JC","year":"2011","unstructured":"Hanselman JC, Bradshaw CD, Brant AF, Cramer CT, Hurley TR, Pinkosky SL, Spahr MA, Washburn JG, Newton RS, Srivastava RAK. ETC-1002 Reduces Circulating and Hepatic Triglyceride Content and Improves Glycemic Control in KKAy Mice. Chicago, IL:American Heart Association: Arteriosclerosis, Thrombosis and Vascular Biology Scientific Sessions. 2011. 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