Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 7:03 AM
Study NCT ID:
NCT05413135
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ARO-APOC3 in Adults With Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 418}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Through 24 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Fasting Triglycerides (TG) Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Percent Change from Baseline in Fasting TG Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Change from Baseline in Apolipoprotein (Apo) C-III Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Percent Change from Baseline in ApoC-III Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Percent Change from Baseline in Fasting Non-HDL-C Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Percent Change from Baseline in Fasting HDL-C Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Percent Change from Baseline in Fasting Total ApoB Over Time', 'timeFrame': 'Through 24 months'}, {'measure': 'Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation', 'timeFrame': 'Through 24 months'}, {'measure': 'Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation', 'timeFrame': 'Through 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study\n* Able and willing to provide written informed consent\n* Completed the 48-week study treatment period in the parent study\n\nExclusion Criteria:\n\n* Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\n* Any new condition or worsening of existing condition or any other situation that would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements or put the subject at additional safety risk\n* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study'}, 'identificationModule': {'nctId': 'NCT05413135', 'briefTitle': 'Study of ARO-APOC3 in Adults With Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arrowhead Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia', 'orgStudyIdInfo': {'id': 'AROAPOC3-2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARO-APOC3', 'description': '1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months', 'interventionNames': ['Drug: ARO-APOC3']}], 'interventions': [{'name': 'ARO-APOC3', 'type': 'DRUG', 'description': 'ARO-APOC3 Injection', 'armGroupLabels': ['ARO-APOC3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site 1', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site 2', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92292', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site 3', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Clincal Research Site 4', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site 5', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site 8', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site 6', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33166', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site 9', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site 10', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site 11', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '30338', 'city': 'Dunwoody', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Site 12', 'geoPoint': {'lat': 33.94621, 'lon': -84.33465}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Research Site 13', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Clinical Research Site 14', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Clinical Research Site 15', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Site 16', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11106', 'city': 'Long Island City', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site 17', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site 18', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site 19', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research Site 20', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Clinical Research Site 21', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Site 22', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Site 23', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '73135', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Clinical Research Site 24', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Site 25', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Site 26', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '77002', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site 29', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site 27', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77099', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site 28', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site 30', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Site 31', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Clinical Research Site 32', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '4068', 'city': 'Milton', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Research Site 33', 'geoPoint': {'lat': -27.47039, 'lon': 153.00312}}, {'zip': '4556', 'city': 'Sippy Downs', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Research Site 34', 'geoPoint': {'lat': -26.71793, 'lon': 153.05475}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Clinical Research Site 35', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Research Site 36', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '6027', 'city': 'Joondalup', 'state': 'Washington', 'country': 'Australia', 'facility': 'Clinical Research Site 37', 'geoPoint': {'lat': -31.74445, 'lon': 115.76835}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Washington', 'country': 'Australia', 'facility': 'Clinical Research Site 38', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'L4K4M2', 'city': 'Concord', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Clinical Research Site 39', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Clinical Research Site 40', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'G7H 7K9', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinical Research Site 41', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinical Research Site 43', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1G 3Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinical Research Site 44', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'H-8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Clinical Research Site 46', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '5600', 'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'Clinical Research Site 47', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Clinical Research Site 48', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3200', 'city': 'Gyöngyös', 'country': 'Hungary', 'facility': 'Clinical Research Site 49', 'geoPoint': {'lat': 47.78257, 'lon': 19.928}}, {'zip': 'H-2900', 'city': 'Komárom', 'country': 'Hungary', 'facility': 'Clinical Research Site 50', 'geoPoint': {'lat': 47.74318, 'lon': 18.11913}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Clinical Research Site 51', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Clinical Research Site 53', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '8601 ZR', 'city': 'Sneek', 'country': 'Netherlands', 'facility': 'Clinical Research Site 54', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '3331LZ', 'city': 'Zwijndrecht', 'country': 'Netherlands', 'facility': 'Clinical Research Site 55', 'geoPoint': {'lat': 51.8175, 'lon': 4.63333}}, {'zip': '2025', 'city': 'Papatoetoe', 'state': 'Aukland', 'country': 'New Zealand', 'facility': 'Clinical Research Site 58', 'geoPoint': {'lat': -36.9682, 'lon': 174.84019}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Clinical Research Site 56', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '8013', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Clinical Research Site 57', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '85-605', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Clinical Research Site 59', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Clinical Research Site 64', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '94 046', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Clinical Research Site 63', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '32-600', 'city': 'Oświęcim', 'country': 'Poland', 'facility': 'Clinical Research Site 60', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'zip': '61-655', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Clinical Research Site 61', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '35-055', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Clinical Research Site 62', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arrowhead Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}