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
NCT ID: NCT05355402
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2022-05-09
2023-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 49 weeks.
Olezarsen
Olezarsen will be administered by SC injection.
Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Interventions
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Olezarsen
Olezarsen will be administered by SC injection.
Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Fall into at least 1 of the following groups (a or b):
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
2. Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L).
3. Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines.
4. Participants must be willing to comply with diet and lifestyle recommendations as able.
Exclusion Criteria
1. Newly diagnosed within 12 weeks of screening
2. Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening
3. Change in basal insulin regimen \> 20% within 3 months prior to Screening
4. For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to Screening
2. Acute coronary syndrome or stroke/transient ischemic attack (TIA) within 6 months prior to Screening
3. 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
4. Active pancreatitis within 4 weeks prior to Screening
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trials Research
Lincoln, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
De La Cruz Research Center
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Research Physicians Network Alliance
Winter Park, Florida, United States
IACT Health
Columbus, Georgia, United States
Evanston Premier Healthcare Research
Evanston, Illinois, United States
Clinical Investigation Specialist
Gurnee, Illinois, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
Aa Mrc, Llc
Flint, Michigan, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, United States
Main Street Physicians Care Waterway
Little River, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
York Clinical Research LLC
Norfolk, Virginia, United States
Bluewater Clinical Research Group Inc
Sarnia, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, , Canada
Countries
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References
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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.
Other Identifiers
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ISIS 678354-CS8
Identifier Type: -
Identifier Source: org_study_id