Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-03 @ 5:49 AM
Study NCT ID:
NCT05355402
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2022-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000731151', 'term': 'olezarsen'}]}}, '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': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06360237', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2024-02-26', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-04-26', 'dispFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline at Month 6 (average of Weeks 25 and 27) in Fasting Triglycerides (TG)', 'timeFrame': 'Baseline and Month 6'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline at Month 12 in Fasting TG', 'timeFrame': 'Baseline and Month 12'}, {'measure': 'Proportion of Participants with Baseline TG < 500 mg/dL (5.65 mmol/L) Who Achieve Fasting TG < 150 milligrams per deciliter (mg/dL) (1.69 millimoles per liter [mmol/L]) at Month 6', 'timeFrame': 'Baseline and Month 6'}, {'measure': 'Proportion of Participants with Baseline TG < 500 mg/dL (5.65 mmol/L) Who Achieve Fasting TG < 150 mg/dL (1.69 mmol/L) at Month 12', 'timeFrame': 'Baseline and Month 12'}, {'measure': 'Proportion of Participants with Baseline TG ≥ 500 mg/dL Who Achieve Fasting TG < 500 mg/dL (5.65 mmol/L) at Month 6', 'timeFrame': 'Baseline and Month 6'}, {'measure': 'Proportion of Participants with Baseline TG ≥ 500 mg/dL Who Achieve Fasting TG < 500 mg/dL at Month 12', 'timeFrame': 'Baseline and Month 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting apoC-III', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting VLDL-C', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting Remnant Cholesterol', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting Non-HDL-C', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting HDL-C', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting TC', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting apoB', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in Fasting LDL-C', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Percent Change From Baseline at Months 6 and 12 in apoA-1', 'timeFrame': 'Baseline, Months 6 and 12'}, {'measure': 'Adjudicated acute pancreatitis event rate during the Treatment Period compared to placebo in patients with ≥ 2 events of adjudicated acute pancreatitis in 5 years prior to enrollment.', 'timeFrame': 'Baseline through Month 12'}, {'measure': 'Adjudicated acute pancreatitis event rate during the Treatment Period compared to placebo.', 'timeFrame': 'Baseline through Month 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertriglyceridemia', 'Atherosclerotic Cardiovascular Disease', 'Severe Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '38587249', 'type': 'BACKGROUND', 'citation': 'Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Murphy SA, Goodrich EL, Zhang S, Gaudet D, Karwatowska-Prokopczuk E, Tsimikas S, Giugliano RP, Sabatine MS; Bridge-TIMI 73a Investigators. Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk. N Engl J Med. 2024 May 16;390(19):1770-1780. doi: 10.1056/NEJMoa2402309. Epub 2024 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the percentage of participants who achieve different thresholds in fasting TG. Another objective is to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).', 'detailedDescription': 'This will be a multi-center, randomized, double-blind, placebo-controlled study in approximately 152 participants with hypertriglyceridemia (triglycerides \\> 150 milligrams per deciliter \\[mg/dL\\]) and established or at increased risk for atherosclerotic cardiovascular disease, and/or with severe hypertriglyceridemia. The study will have an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥ 18 years at the time of informed consent\n2. Fall into at least 1 of the following groups (a or b):\n\n 1. Hypertriglyceridemia with fasting TG ≥ 150 mg/dL (1.69 millimoles per liter \\[mmol/L\\]) and \\< 500 mg/dL (5.65 mmol/L) with either clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or at increased risk for ASCVD\n 2. Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L).\n3. Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines.\n4. Participants must be willing to comply with diet and lifestyle recommendations as able.\n\nExclusion Criteria:\n\n1. Diabetes with any of the following:\n\n 1. Newly diagnosed within 12 weeks of screening\n 2. Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening\n 3. Change in basal insulin regimen \\> 20% within 3 months prior to Screening\n 4. For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to Screening\n2. Acute coronary syndrome or stroke/transient ischemic attack (TIA) within 6 months prior to Screening\n3. Major surgery, peripheral revascularization, or non-urgent percutaneous coronary intervention (PCI) within 3 months prior to Screening, or upcoming planned major surgery or major procedure (e.g., arterial revascularization) during the course of the study\n4. Active pancreatitis within 4 weeks prior to Screening'}, 'identificationModule': {'nctId': 'NCT05355402', 'briefTitle': 'A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Phase 2b Study of ISIS 678354 in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia', 'orgStudyIdInfo': {'id': 'ISIS 678354-CS8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olezarsen', 'description': 'Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 49 weeks.', 'interventionNames': ['Drug: Olezarsen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Olezarsen', 'type': 'DRUG', 'otherNames': ['ISIS 678354', 'AKCEA-APOCIII-LRx'], 'description': 'Olezarsen will be administered by SC injection.', 'armGroupLabels': ['Olezarsen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33184', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'De La Cruz Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research, Inc.', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Physicians Network Alliance', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'IACT Health', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Premier Healthcare Research', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Investigation Specialist', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '51501', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'West Broadway Clinic', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Louisville Metabolic and Atherosclerosis Research Center (L-MARC)', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48504', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Aa Mrc, Llc', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research of South Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center, Inc.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Green and Seidner Family Practice Associates', 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '29566', 'city': 'Little River', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Main Street Physicians Care Waterway', 'geoPoint': {'lat': 33.87323, 'lon': -78.61418}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37388', 'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Center for Clinical Trials', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Southern Endocrinology Associates', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '23504', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'York Clinical Research LLC', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': 'N7t 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bluewater Clinical Research Group Inc', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'G7H 7K9', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Ecogene-21', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Clinique des Maladies Lipidiques de Quebec Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}