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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02300233
Other study ID # ISIS 304801-CS16
Secondary ID 2014-003434-93
Status Completed
Phase Phase 3
First received
Last updated
Start date February 5, 2015
Est. completion date January 24, 2017

Study information

Verified date March 2022
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date January 24, 2017
Est. primary completion date July 27, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
Placebo
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.

Locations

Country Name City State
Canada IONIS Investigative Site Chicoutimi Quebec
Canada IONIS Investigative Site London Ontario
Canada IONIS Investigative Site Sainte-Foy Quebec
Canada IONIS Investigative Site Vancouver British Columbia
France IONIS Investigative Site Dijon
France IONIS Investigative Site Marseille
France IONIS Investigative Site Paris
France IONIS Investigative Site Saint Herblain
Germany IONIS Investigative Site Berlin
Germany IONIS Investigative Site Dresden
Germany IONIS Investigative Site Koeln North Rhine-Westphalia
Netherlands IONIS Investigative Site Amsterdam North Holland
Netherlands IONIS Investigative Site Rotterdam South Holland
Netherlands IONIS Investigative Site Utrecht
United Kingdom IONIS Investigative Site Manchester
United Kingdom IONIS Investigative Site Peterborough
United States IONIS Investigative Site Benson North Carolina
United States IONIS Investigative Site Boca Raton Florida
United States IONIS Investigative Site Boston Massachusetts
United States IONIS Investigative Site Chapel Hill North Carolina
United States IONIS Investigative Site Cincinnati Ohio
United States IONIS Investigative Site Encinitas California
United States IONIS Investigative Site Farmville North Carolina
United States IONIS Investigative Site Grandville Michigan
United States IONIS Investigative Site Greenville North Carolina
United States IONIS Investigative Site Houston Texas
United States IONIS Investigative Site Kansas City Kansas
United States IONIS Investigative Site Kettering Ohio
United States IONIS Investigative Site Marion Ohio
United States IONIS Investigative Site Miami Florida
United States IONIS Investigative Site Morrisville North Carolina
United States IONIS Investigative Site Norfolk Virginia
United States IONIS Investigative Site North Massapequa New York
United States IONIS Investigative Site Oklahoma City Oklahoma
United States IONIS Investigative Site Portland Oregon
United States IONIS Investigative Site Providence Rhode Island
United States IONIS Investigative Site Raleigh North Carolina
United States IONIS Investigative Site Salisbury Maryland
United States IONIS Investigative Site Salt Lake City Utah
United States IONIS Investigative Site San Francisco California
United States IONIS Investigative Site Seattle Washington
United States IONIS Investigative Site Sterling Illinois
United States IONIS Investigative Site Towson Maryland
United States IONIS Investigative Site Wilson North Carolina
United States IONIS Investigative Site Wilson North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc. Akcea Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 Baseline to 3 months
Secondary Absolute Change in Fasting TG From Baseline to Month 3 Baseline to 3 months
Secondary Treatment Response Rate Defined as Participants With Fasting TG = 40% Reduction From Baseline at Month 3 Baseline to 3 months
Secondary Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline Baseline to 3 months
Secondary Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 mg/dL = milligrams per deciliter Baseline to 3 months
Secondary 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. Baseline to 3 and 6 months
Secondary Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants Baseline to 3 and 6 months
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