Severe Hypertriglyceridemia | Olezarsen
A Study of ISIS 678354 Administered to Participants With Severe Hypertriglyceridemia
This is a multi-center, randomized, double-blind, placebo-controlled study in up to approximately 540 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.
The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.
Olezarsen
Purpose of Study
The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Eligibility
Age:
18 +Sex:
AllKey Inclusion / Exclusion Criteria
Inclusion Criteria:
- Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
- Patients 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.
Exclusion Criteria:
- Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
- Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
- Total bilirubin > upper limit of normal unless due to Gilbert’s syndrome
- Estimated GFR < 30 mL/min/1.73 m^2
Conditions:
Severe Hypertriglyceridemia
Status:
Recruiting
Phase:
Phase 3
Clinical Trials ID
NCT05079919
Read Detailed Summary:
Start Date / End Date:
10 2021 - 02 2025
Intervention:
Olezarsen
Enrollment:
540