The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia

• Status: Completed
• Trial end date: 2017-01-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in patients with Hypertriglyceridemia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Collaborator: Akcea Therapeutics

Criteria

Inclusion Criteria:

1. BMI ≤ 45 kg/m2

2. Fasting TG ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.

3. If on statin or fibrate, patients must be on stable, labeled dose for at least 3 months prior to screening. Patients not receiving these drugs within 4 weeks prior to screening are also eligible.

Exclusion Criteria:

1. Type 1 diabetes mellitus

2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening

3. Acute pancreatitis within 3 months of screening

4. Acute Coronary Syndrome within 6 months of screening

5. Major surgery within 3 months of screening

6. Prior exposure to ISIS 304801

7. Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study