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

Ionis Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Volanesorsen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02300233

2014-003434-93 (EudraCT Number)

ISIS 304801-CS16

Details and patient eligibility

About

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

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Body mass index (BMI) ≤ 45 kg/m2
2. Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
3. 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.

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 participant participating in or completing the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.

Treatment:

Drug: Placebo

Volanesorsen 300 mg weekly

Experimental group

Description:

Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.

Treatment:

Drug: Volanesorsen

Volanesorsen 300 mg biweekly, post Week 13

Experimental group

Description:

Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.

Treatment:

Drug: Volanesorsen