A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia an… (NCT05355402) | Clinical Trial Compass
CompletedPhase 2
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
United States154 participantsStarted 2022-05-09
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Diabetes with any of the following:
✕. Newly diagnosed within 12 weeks of screening
✕. Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening
✕
What they're measuring
1
Percent Change From Baseline in Fasting TG at Month 6
. 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