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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Volanesorsen
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site
  • IONIS Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Volanesorsen 300 mg weekly

Volanesorsen 300 mg biweekly, post Week 13

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absolute Change in Fasting TG From Baseline to Month 3
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
mg/dL = milligrams per deciliter
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
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.
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants

Full Information

First Posted
November 20, 2014
Last Updated
March 17, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
Collaborators
Akcea Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02300233
Brief Title
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Official Title
The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2015 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
January 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
Collaborators
Akcea Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Arm Title
Volanesorsen 300 mg weekly
Arm Type
Experimental
Arm Description
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Arm Title
Volanesorsen 300 mg biweekly, post Week 13
Arm Type
Experimental
Arm Description
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
Volanesorsen
Other Intervention Name(s)
ISIS 304801
Intervention Description
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Primary Outcome Measure Information:
Title
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Absolute Change in Fasting TG From Baseline to Month 3
Time Frame
Baseline to 3 months
Title
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Time Frame
Baseline to 3 months
Title
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Time Frame
Baseline to 3 months
Title
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
Description
mg/dL = milligrams per deciliter
Time Frame
Baseline to 3 months
Title
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Description
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.
Time Frame
Baseline to 3 and 6 months
Title
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Time Frame
Baseline to 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IONIS Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
IONIS Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
IONIS Investigative Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
IONIS Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
IONIS Investigative Site
City
Sterling
State/Province
Illinois
ZIP/Postal Code
61081
Country
United States
Facility Name
IONIS Investigative Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
IONIS Investigative Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
73103
Country
United States
Facility Name
IONIS Investigative Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
IONIS Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
IONIS Investigative Site
City
Grandville
State/Province
Michigan
ZIP/Postal Code
49418
Country
United States
Facility Name
IONIS Investigative Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758-1802
Country
United States
Facility Name
IONIS Investigative Site
City
Benson
State/Province
North Carolina
ZIP/Postal Code
27504
Country
United States
Facility Name
IONIS Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
IONIS Investigative Site
City
Farmville
State/Province
North Carolina
ZIP/Postal Code
27828
Country
United States
Facility Name
IONIS Investigative Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
IONIS Investigative Site
City
Morrisville
State/Province
North Carolina
ZIP/Postal Code
27560
Country
United States
Facility Name
IONIS Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
IONIS Investigative Site
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
IONIS Investigative Site
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
IONIS Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
IONIS Investigative Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
IONIS Investigative Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
IONIS Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
IONIS Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
IONIS Investigative Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
IONIS Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
IONIS Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
IONIS Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
IONIS Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
IONIS Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
IONIS Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B7
Country
Canada
Facility Name
IONIS Investigative Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
IONIS Investigative Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
IONIS Investigative Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
IONIS Investigative Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
IONIS Investigative Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
IONIS Investigative Site
City
Saint Herblain
Country
France
Facility Name
IONIS Investigative Site
City
Koeln
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50937
Country
Germany
Facility Name
IONIS Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
IONIS Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
IONIS Investigative Site
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
IONIS Investigative Site
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
IONIS Investigative Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
IONIS Investigative Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
IONIS Investigative Site
City
Peterborough
ZIP/Postal Code
PE3 6DA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33798466
Citation
Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.
Results Reference
derived

Learn more about this trial

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

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