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Completed

NCT Number: NCT02300233

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

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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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IONIS Investigative Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Volanesorsen

Drug

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

Other names: ISIS 304801

Placebo

Drug

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

Primary outcomes

  1. Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3

    Time frame: Baseline to 3 months

Secondary outcomes

  1. Absolute Change in Fasting TG From Baseline to Month 3

    Time frame: Baseline to 3 months

  2. Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3

    Time frame: Baseline to 3 months

  3. Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline

    Time frame: Baseline to 3 months

  4. Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3

    Time frame: Baseline to 3 months

    mg/dL = milligrams per deciliter

  5. Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)

    Time frame: Baseline to 3 and 6 months

    HOMA-IR was calculated using the following formula: fasting insulin micro-international units per millimeter (μIU/mL) x fasting glucose mg/dL]/405. A negative change from baseline indicates improvement; a positive change from baseline indicates worsening.

  6. Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants

    Time frame: Baseline to 3 and 6 months

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Collaborators

  • Akcea Therapeutics

Registry information

Official study title

The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 24, 2014
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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