Clinical trial NCT02300233: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Akcea Therapeutics
First posted: 2014-11-24
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Absolute Change in Fasting TG From Baseline to Month 3
timeFrame: Baseline to 3 months
measure: Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
timeFrame: Baseline to 3 months
measure: Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
timeFrame: Baseline to 3 months
measure: Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
timeFrame: Baseline to 3 months
measure: Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
timeFrame: Baseline to 3 and 6 months
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
timeFrame: Baseline to 3 and 6 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: IONIS Investigative Site
state: California
city: San Francisco
country: United States
facility: IONIS Investigative Site
state: California
city: Boca Raton
country: United States
facility: IONIS Investigative Site
state: Florida
city: Miami
country: United States
facility: IONIS Investigative Site
state: Florida
city: Sterling
country: United States
facility: IONIS Investigative Site
state: Illinois
city: Kansas City
country: United States
facility: IONIS Investigative Site
state: Kansas
city: Salisbury
country: United States
facility: IONIS Investigative Site
state: Maryland
city: Towson
country: United States
facility: IONIS Investigative Site
state: Maryland
city: Boston
country: United States
facility: IONIS Investigative Site
state: Massachusetts
city: Grandville
country: United States
facility: IONIS Investigative Site
state: Michigan
city: North Massapequa
country: United States
facility: IONIS Investigative Site
state: New York
city: Benson
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Chapel Hill
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Farmville
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Greenville
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Morrisville
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Wilson
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Wilson
country: United States
facility: IONIS Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: IONIS Investigative Site
state: Ohio
city: Kettering
country: United States
facility: IONIS Investigative Site
state: Ohio
city: Marion
country: United States
facility: IONIS Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: IONIS Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: IONIS Investigative Site
state: Oregon
city: Providence
country: United States
facility: IONIS Investigative Site
state: Rhode Island
city: Houston
country: United States
facility: IONIS Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: IONIS Investigative Site
state: Utah
city: Norfolk
country: United States
facility: IONIS Investigative Site
state: Virginia
city: Seattle
country: United States
facility: IONIS Investigative Site
state: Washington
city: Vancouver
country: Canada
facility: IONIS Investigative Site
state: British Columbia
city: London
country: Canada
facility: IONIS Investigative Site
state: Ontario
city: Chicoutimi
country: Canada
facility: IONIS Investigative Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: IONIS Investigative Site
state: Quebec
city: Dijon
country: France
facility: IONIS Investigative Site
city: Marseille
country: France
facility: IONIS Investigative Site
city: Paris
country: France
facility: IONIS Investigative Site
city: Saint Herblain
country: France
facility: IONIS Investigative Site
city: Koeln
country: Germany
facility: IONIS Investigative Site
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: IONIS Investigative Site
city: Dresden
country: Germany
facility: IONIS Investigative Site
city: Amsterdam
country: Netherlands
facility: IONIS Investigative Site
state: North Holland
city: Rotterdam
country: Netherlands
facility: IONIS Investigative Site
state: South Holland
city: Utrecht
country: Netherlands
facility: IONIS Investigative Site
city: Manchester
country: United Kingdom
facility: IONIS Investigative Site
city: Peterborough
country: United Kingdom
facility: IONIS Investigative Site
Study officials:
References:
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.