A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia
Ionis Pharmaceuticals, Inc.
Summary
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).
Description
This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg/dL) \[3.95 millimoles per liter (mmol/L)\] or with sHTG (fasting TG ≥ 500 mg/dL \[5.65 mmol/L\]). 2. Participants should be on standard of care lipid-lowering medications per local guidelines. Key Exclusion Criteria: 1. Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening. 2. Alanine aminotransferase or aspartate aminotransferase \> 2.0 × upper limit of normal. 3. Total bilirubin \> 1.5 upper limit of normal unless due to Gilbert's syndrome. 4. Estimated GFR \< 30 mL/min/…
Interventions
- Drug