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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertriglyceridemia

In brief

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

Key facts

Study ID

NCT02300233

Run by

Ionis Pharmaceuticals, Inc.

People needed

114

Starts

2015-02-05

Expected to finish

2017-01-24

Last updated by the study team

2022-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index (BMI) ≤ 45 kg/m2
• Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
• If on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. Participants not receiving these drugs within 4 weeks prior to screening are also eligible.

You may not qualify if…

• Type 1 diabetes mellitus
• Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening
• Acute pancreatitis within 3 months of screening
• Acute Coronary Syndrome within 6 months of screening
• Major surgery within 3 months of screening
• Prior exposure to ISIS 304801
• Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study

Where it is running

• IONIS Investigative Site — Encinitas, California, United States
• IONIS Investigative Site — San Francisco, California, United States
• IONIS Investigative Site — Boca Raton, Florida, United States
• IONIS Investigative Site — Miami, Florida, United States
• IONIS Investigative Site — Sterling, Illinois, United States
• IONIS Investigative Site — Kansas City, Kansas, United States
• IONIS Investigative Site — Salisbury, Maryland, United States
• IONIS Investigative Site — Towson, Maryland, United States
• IONIS Investigative Site — Boston, Massachusetts, United States
• IONIS Investigative Site — Grandville, Michigan, United States
• IONIS Investigative Site — North Massapequa, New York, United States
• IONIS Investigative Site — Benson, North Carolina, United States
• IONIS Investigative Site — Chapel Hill, North Carolina, United States
• IONIS Investigative Site — Farmville, North Carolina, United States
• IONIS Investigative Site — Greenville, North Carolina, United States
• IONIS Investigative Site — Morrisville, North Carolina, United States
• IONIS Investigative Site — Raleigh, North Carolina, United States
• IONIS Investigative Site — Wilson, North Carolina, United States
• IONIS Investigative Site — Wilson, North Carolina, United States
• IONIS Investigative Site — Cincinnati, Ohio, United States
• IONIS Investigative Site — Kettering, Ohio, United States
• IONIS Investigative Site — Marion, Ohio, United States
• IONIS Investigative Site — Oklahoma City, Oklahoma, United States
• IONIS Investigative Site — Portland, Oregon, United States
• IONIS Investigative Site — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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