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

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ClinicalTrials.gov Identifier: NCT02300233
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : April 13, 2022
Last Update Posted : April 13, 2022
Sponsor:
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 24, 2014
Results First Submitted Date  ICMJE January 13, 2022
Results First Posted Date  ICMJE April 13, 2022
Last Update Posted Date April 13, 2022
Actual Study Start Date  ICMJE February 5, 2015
Actual Primary Completion Date July 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2022)
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 [ Time Frame: Baseline to 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
The percent change in fasting triglycerides (TG) from baseline [ Time Frame: Baseline and 13 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2022)
  • Absolute Change in Fasting TG From Baseline to Month 3 [ Time Frame: 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 ]
  • Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline [ Time Frame: 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
  • 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.
  • Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants [ Time Frame: Baseline to 3 and 6 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Official Title  ICMJE The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
Brief Summary The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE
  • Drug: Volanesorsen
    300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
    Other Name: ISIS 304801
  • Drug: Placebo
    Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
    Intervention: Drug: Placebo
  • Experimental: Volanesorsen 300 mg weekly
    Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
    Intervention: Drug: Volanesorsen
  • Experimental: Volanesorsen 300 mg biweekly, post Week 13
    Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
    Intervention: Drug: Volanesorsen
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
114
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2014)
75
Actual Study Completion Date  ICMJE January 24, 2017
Actual Primary Completion Date July 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300233
Other Study ID Numbers  ICMJE ISIS 304801-CS16
2014-003434-93 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ionis Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ionis Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Akcea Therapeutics
Investigators  ICMJE Not Provided
PRS Account Ionis Pharmaceuticals, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP