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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia

In brief

The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were 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).

Key facts

Study ID

NCT05355402

Run by

Ionis Pharmaceuticals, Inc.

People needed

154

Starts

2022-05-09

Expected to finish

2023-12-21

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 years at the time of informed consent
• Fall into at least 1 of the following groups (a or b):
• 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
• Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L).
• Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines.
• Participants must be willing to comply with diet and lifestyle recommendations as able.

You may not qualify if…

• Diabetes with any of the following:
• Newly diagnosed within 12 weeks of screening
• Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening
• Change in basal insulin regimen > 20% within 3 months prior to Screening
• For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to Screening
• Acute coronary syndrome or stroke/transient ischemic attack (TIA) within 6 months prior to Screening
• 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
• Active pancreatitis within 4 weeks prior to Screening

Where it is running

• 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

Full record on ClinicalTrials.gov

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