A study of olezarsen administered subcutaneously to participants with severe hypertriglyceridemia

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The company Ionis Pharmaceuticals, Inc is enrolling patients into the clinical trial investigating A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia. The study start date is August 31, 2022.

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

The trial is designed to enroll male and female 18 Years and older and is being conducted in the Louisville Metabolic and Atherosclerosis Research Center (L-MARC), Louisville, Kentucky; Pioneer Research Solutions, Inc, Houston, Texas; FMC Science, Lampasas, Texas; Texas Institute of Cardiology, McKinney, Texas, United States.

Patients that may be enrolled must have Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification visits, be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines, and they must be willing to comply with diet and lifestyle recommendations as able.

Among the exclusion Criteria are Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening;  Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal; Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome; Estimated GFR < 30 mL/min/1.73 m^2

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05552326.

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