Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-03-04 @ 7:00 AM
Study NCT ID:
NCT01968720
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2015-07-27', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2013-10-21', 'dispFirstSubmitQcDate': '2015-07-27', 'studyFirstSubmitQcDate': '2013-10-21', 'dispFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Frequency of adverse events', 'timeFrame': '4 weeks', 'description': 'Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up.\n\nSafety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.'}, {'measure': 'Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemias', 'Hypertriglyceridemia', 'Dyslipidemias', 'Lipid Metabolism Disorders', 'Metabolic Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.\n\nThis is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 74 years at Screening\n* Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose 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 or use of insulin\n* History of pancreatitis'}, 'identificationModule': {'nctId': 'NCT01968720', 'briefTitle': 'Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catabasis Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia', 'orgStudyIdInfo': {'id': 'CAT-2003-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAT-2003 or Placebo', 'description': 'All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.', 'interventionNames': ['Drug: CAT-2003', 'Drug: Placebo']}], 'interventions': [{'name': 'CAT-2003', 'type': 'DRUG', 'armGroupLabels': ['CAT-2003 or Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['CAT-2003 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catabasis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}