Overview

A Study of ISIS 678354 Administered to Participants With Severe Hypertriglyceridemia

Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to evaluate the efficacy of ISIS 678354 as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Criteria
Key Inclusion Criteria:

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

- Patients should be on standard of care lipid-lowering medications per local guidelines
unless intolerant. 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.

Key Exclusion Criteria:

- Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening

- Platelet count < 100K/cubic millimeters at Screening or Qualification

- 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 < 40 mL/min/1.73 m^2