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NCT05610280
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
Conditions: Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 1312
Sponsor: Ionis Pharmaceuticals, Inc.
Location: United States
Summary
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.
Eligibility Criteria
Inclusion Criteria:Participants must fall into 1 of the following groups (a or b):a. Hypertriglyceridemia with fasting TG ≥150 mg/dL (1.69 millimoles per liter [mmol/L]) and <500 mg/dL (5.65 mmol/L) with eitherClinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) orAt increased risk for ASCVD b.
Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)Participants should be on standard of care (SOC) lipid-lowering medications per local guidelines.
Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.Exclusion Criteria:Hemoglobin A1c (HbA1c) ≥ 9.5% at ScreeningAlanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normalTotal bilirubin > upper limit of normal unless due to Gilbert's syndromeEstimated GFR < 30 mL/min/1.73
m^2NOTE: Other Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05610280). StuddyBuddy aggregates publicly available trial information.