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The COMPASS Study: A Study of...

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

Last Updated: 2022-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-05

Study Completion Date

2017-01-24

Brief Summary

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

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Detailed Description

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Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Volanesorsen 300 mg weekly

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

Group Type EXPERIMENTAL

Volanesorsen

Intervention Type DRUG

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

Volanesorsen 300 mg biweekly, post Week 13

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

Group Type EXPERIMENTAL

Volanesorsen

Intervention Type DRUG

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

Interventions

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Volanesorsen

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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ISIS 304801

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers