Hypertriglyceridemia, Severe Hypertriglyceridemia
Conditions
Brief 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).
Detailed 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.
Interventions
DRUGION775
ION775 will be administered by SC injection.
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/1.73 m\^2. Note: Other protocol pre-specified inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Fasting Triglyceride (TG) | Baseline, Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Up to 12 Months |
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) | Baseline, Month 6 |
| Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III) | Baseline, Month 6 |
| Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) | Baseline, Month 6 |
| Percent Change From Baseline in Remnant Cholesterol When Directly Measured | Baseline, Month 6 |
| Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations | Up to 12 Months |
Countries
Canada, United States
Contacts
CONTACTIonis Pharmaceuticals, Inc.
Outcome results
None listed