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