Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT01912560
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, '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': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2015-02-24', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2013-07-25', 'dispFirstSubmitQcDate': '2015-02-24', 'studyFirstSubmitQcDate': '2013-07-29', 'dispFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia', 'timeFrame': '4 weeks'}, {'measure': 'Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol', 'timeFrame': '4 weeks'}, {'measure': 'Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia', 'timeFrame': '4 weeks'}, {'measure': 'Frequency of adverse events', 'timeFrame': '4 weeks', 'description': 'Safety and tolerability will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia', 'Hypercholesterolemia', 'Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 69 years at Screening\n* Hypertriglyceridemia (TG ≥ 200 mg/dL and \\< 500 mg/dL and non-HDL-C ≥ 100 mg/dL and \\< 220 mg/dL) OR\n* Hypercholesterolemia (LDL-C ≥ 100 mg/dL and \\< 190 mg/dL and TG value \\< 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.\n* Body mass index (BMI) ≤ 45 kg/m2\n\nExclusion Criteria:\n\n* History of any major cardiovascular event within 6 months of Screening\n* Type I diabetes mellitus\n* Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism\n* Any statin at the highest approved dose\n* Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.\n* Active peptic ulcer disease or a history of muscle disease or myopathy'}, 'identificationModule': {'nctId': 'NCT01912560', 'acronym': 'PATHWAYS I', 'briefTitle': 'Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catabasis Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)', 'orgStudyIdInfo': {'id': 'CAT-2003-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAT-2003 or Placebo Dose 1', 'description': 'Daily for 28 days in patients with moderate hypertriglyceridemia', 'interventionNames': ['Drug: CAT-2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CAT-2003 or Placebo Dose 2', 'description': 'Daily for 28 days in patients with moderate hypertriglyceridemia', 'interventionNames': ['Drug: CAT-2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CAT-2003 or Placebo Dose 3', 'description': 'Daily for 28 days in patients with moderate hypertriglyceridemia', 'interventionNames': ['Drug: CAT-2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CAT-2003 or Placebo Dose 4', 'description': 'Daily for 28 days in patients with hypercholesterolemia who are on a statin', 'interventionNames': ['Drug: CAT-2003', 'Drug: Placebo', 'Drug: Statin']}], 'interventions': [{'name': 'CAT-2003', 'type': 'DRUG', 'armGroupLabels': ['CAT-2003 or Placebo Dose 1', 'CAT-2003 or Placebo Dose 2', 'CAT-2003 or Placebo Dose 3', 'CAT-2003 or Placebo Dose 4']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['CAT-2003 or Placebo Dose 1', 'CAT-2003 or Placebo Dose 2', 'CAT-2003 or Placebo Dose 3', 'CAT-2003 or Placebo Dose 4']}, {'name': 'Statin', 'type': 'DRUG', 'description': 'All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.', 'armGroupLabels': ['CAT-2003 or Placebo Dose 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35662', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32223', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '04120', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': 'G1V 4M6', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catabasis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}