Overview

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Status:
Recruiting

Trial end date:
2025-07-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ionis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification

2. Participants must be on lipid-lowering therapy that should adhere to standard of care
(SOC) 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.

3. Participants must be willing to comply with diet and lifestyle recommendations as
able.

Exclusion Criteria:

1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening

2. Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal

3. Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome

4. Estimated GFR < 30 mL/min/1.73 m^2