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

March 17, 2022 updated by: Ionis Pharmaceuticals, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Ionis Investigative Site
    • Ontario
      • London, Ontario, Canada, N6A 5B7
        • Ionis Investigative Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ionis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1V 4M6
        • Ionis Investigative Site
  • France
      • Dijon, France, 21079
        • Ionis Investigative Site
      • Marseille, France, 13385
        • Ionis Investigative Site
      • Paris, France, 75013
        • Ionis Investigative Site
      • Saint Herblain, France
        • Ionis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Ionis Investigative Site
      • Dresden, Germany, 01307
        • Ionis Investigative Site
    • North Rhine-Westphalia
      • Koeln, North Rhine-Westphalia, Germany, 50937
        • Ionis Investigative Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Ionis Investigative Site
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Ionis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3045 PM
        • Ionis Investigative Site
  • United Kingdom
      • Manchester, United Kingdom, M23 9LT
        • Ionis Investigative Site
      • Peterborough, United Kingdom, PE3 6DA
        • Ionis Investigative Site
  • United States
    • California
      • Encinitas, California, United States, 92024
        • Ionis Investigative Site
      • San Francisco, California, United States, 94143
        • Ionis Investigative Site
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Ionis Investigative Site
      • Miami, Florida, United States, 33147
        • Ionis Investigative Site
    • Illinois
      • Sterling, Illinois, United States, 61081
        • Ionis Investigative Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Ionis Investigative Site
    • Maryland
      • Salisbury, Maryland, United States, 73103
        • Ionis Investigative Site
      • Towson, Maryland, United States, 21204
        • Ionis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ionis Investigative Site
    • Michigan
      • Grandville, Michigan, United States, 49418
        • Ionis Investigative Site
    • New York
      • North Massapequa, New York, United States, 11758-1802
        • Ionis Investigative Site
    • North Carolina
      • Benson, North Carolina, United States, 27504
        • Ionis Investigative Site
      • Chapel Hill, North Carolina, United States, 27609
        • Ionis Investigative Site
      • Farmville, North Carolina, United States, 27828
        • Ionis Investigative Site
      • Greenville, North Carolina, United States, 27834
        • Ionis Investigative Site
      • Morrisville, North Carolina, United States, 27560
        • Ionis Investigative Site
      • Raleigh, North Carolina, United States, 27612
        • Ionis Investigative Site
      • Wilson, North Carolina, United States, 27609
        • Ionis Investigative Site
      • Wilson, North Carolina, United States, 27893
        • Ionis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Ionis Investigative Site
      • Kettering, Ohio, United States, 45429
        • Ionis Investigative Site
      • Marion, Ohio, United States, 43302
        • Ionis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Ionis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Ionis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Ionis Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Ionis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Ionis Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Ionis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Ionis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Drug: Placebo
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Experimental: Volanesorsen 300 mg weekly
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Drug: Volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
Other Names:
  • ISIS 304801
Experimental: Volanesorsen 300 mg biweekly, post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Drug: Volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
Other Names:
  • ISIS 304801

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
Time Frame: Baseline to 3 months
Baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change in Fasting TG From Baseline to Month 3
Time Frame: Baseline to 3 months
Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Time Frame: Baseline to 3 months
Baseline to 3 months
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Time Frame: Baseline to 3 months
Baseline to 3 months
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
Baseline to 3 months
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.
Baseline to 3 and 6 months
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Time Frame: Baseline to 3 and 6 months
Baseline to 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Collaborators

Akcea Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2015

Primary Completion (Actual)

July 27, 2016

Study Completion (Actual)

January 24, 2017

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 304801-CS16
  • 2014-003434-93 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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