Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-04 @ 7:29 PM
Study NCT ID:
NCT02072161
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2014-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2015-08-13', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2014-02-24', 'dispFirstSubmitQcDate': '2015-08-27', 'studyFirstSubmitQcDate': '2014-02-24', 'dispFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)', 'timeFrame': '12 weeks'}, {'measure': 'Percent change in apolipoprotein B (ApoB)', 'timeFrame': '12 weeks'}, {'measure': 'Percent change in total cholesterol (TC)', 'timeFrame': '12 weeks'}, {'measure': 'Percent change in high-sensitivity C-reactive protein (hsCRP)', 'timeFrame': '12 weeks'}, {'measure': 'Percent change in triglycerides (TG)', 'timeFrame': '12 weeks'}, {'measure': 'Percent change in lipoprotein particle number', 'timeFrame': '12 weeks'}, {'measure': 'Safety using adverse event reports; clinical laboratory results', 'timeFrame': '12 weeks'}, {'measure': 'Safety using adverse event reports; vital signs', 'timeFrame': '12 weeks'}, {'measure': 'Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Statin', 'LDL', 'Cholesterol'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '24385236', 'type': 'BACKGROUND', 'citation': 'Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. 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. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.'}, {'pmid': '23770179', 'type': 'BACKGROUND', 'citation': 'Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. 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. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.'}, {'pmid': '23709692', 'type': 'BACKGROUND', 'citation': 'Filippov S, Pinkosky SL, Lister RJ, Pawloski C, Hanselman JC, Cramer CT, Srivastava RAK, Hurley TR, Bradshaw CD, Spahr MA, Newton RS. ETC-1002 regulates immune response, leukocyte homing, and adipose tissue inflammation via LKB1-dependent activation of macrophage AMPK. J Lipid Res. 2013 Aug;54(8):2095-2108. doi: 10.1194/jlr.M035212. Epub 2013 May 24.'}, {'pmid': '23118444', 'type': 'BACKGROUND', 'citation': 'Pinkosky SL, Filippov S, Srivastava RA, Hanselman JC, Bradshaw CD, Hurley TR, Cramer CT, Spahr MA, Brant AF, Houghton JL, Baker C, Naples M, Adeli K, Newton RS. AMP-activated protein kinase and ATP-citrate lyase are two distinct molecular targets for ETC-1002, a novel small molecule regulator of lipid and carbohydrate metabolism. J Lipid Res. 2013 Jan;54(1):134-51. doi: 10.1194/jlr.M030528. Epub 2012 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.', 'detailedDescription': 'Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL\n* Fasting mean TG level ≤400 mg/dL\n* Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease within 12 months of screening\n* Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued\n* Type 1 diabetes or uncontrolled type 2 diabetes\n* Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening\n* History of chronic musculoskeletal symptoms such as fibromyalgia\n* Uncontrolled hypothyroidism\n* Liver disease or dysfunction\n* Renal dysfunction or nephritic syndrome\n* Gastrointestinal conditions or procedures or surgeries\n* Hematologic or coagulation disorders or low hemoglobin levels\n* HIV or AIDS\n* History of malignancy\n* History of drug or alcohol abuse within 2 years\n* Use of experimental or investigational drugs within 30 days of screening\n* Use of ETC-1002 in a previous clinical study'}, 'identificationModule': {'nctId': 'NCT02072161', 'briefTitle': 'Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1002-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ETC-1002 120 mg/day', 'description': 'Orally, once daily in morning as capsules', 'interventionNames': ['Drug: ETC-1002', 'Drug: Statin Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'ETC-1002 180 mg/day', 'description': 'Orally, once daily in morning as capsules', 'interventionNames': ['Drug: ETC-1002', 'Drug: Statin Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Orally, once daily in morning', 'interventionNames': ['Drug: Placebo', 'Drug: Statin Therapy']}], 'interventions': [{'name': 'ETC-1002', 'type': 'DRUG', 'description': 'ETC-1002 capsules, taken once daily oral', 'armGroupLabels': ['ETC-1002 120 mg/day', 'ETC-1002 180 mg/day']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules, taken once daily oral', 'armGroupLabels': ['Placebo']}, {'name': 'Statin Therapy', 'type': 'DRUG', 'description': 'Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.', 'armGroupLabels': ['ETC-1002 120 mg/day', 'ETC-1002 180 mg/day', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35662', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94595', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '32081', 'city': 'Ponte Vedra', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.22746, 'lon': -81.38008}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30066', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '39150', 'city': 'Port Gibson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 31.96099, 'lon': -90.98399}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45005', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '44124', 'city': 'Lyndhurst', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.52005, 'lon': -81.48873}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29464', 'city': 'Mt. 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