Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia

Inclusion Criteria:

- Severe hypertriglyceridemia

Exclusion Criteria:

- HbA1c >/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2
weeks in the last year

- Body mass index (BMI) >40 kg/m2

- History of bariatric surgery or currently on weight loss drugs

- Use of oral contraceptives or hormone replacement therapy or statins unless stable
for 3 months prior to dosing

- Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil
or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3
patients: unable to discontinue use of systemic corticosteroids at least 6 weeks
prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty
acids unless on a stable well controlled dose for at least 30 days prior to screening
that is not anticipated to change during the study period. Group 4 patients: unable
to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use
of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless
on a stable well controlled dose for at least 30 days prior to screening that is not
anticipated to change during the study period.

- Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with
potential lipid-altering effects unless dose is stable and well controlled for 30
days prior to dosing

- Any Screening laboratory values that are out of allowed reference ranges

- Inability to comply with protocol or study procedures

- Any other significant illness or condition that may adversely affect the subjects
participation in the study