Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)

Phase

Condition

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

TX210468

Ages 18-80
All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose- ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in patients with hypertriglyceridemia and established CVD.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease
Fasting serum TG ≥ 200 mg/dL (≥ 2.3 mmol/L) and ≤ 500 mg/dL (≥ 5.7 mmol/L) at Screening
Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit
Must be on standard-of-care preventative therapy for known CVD risk factors

Key

Exclusion

Exclusion Criteria:

Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/TIA
Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis
Heart failure New York Heart Association (NYHA) class IV
Type 1 diabetes mellitus
Type 2 diabetes mellitus with any of the following:
Newly diagnosed within 12 weeks of screening
HbA1c ≥ 9.0% at Screening
Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of new medication within 12 weeks of screening [with the exception of ± 10 units of insulin BMI > 40 kg/m2