Hypertriglyceridemia Clinical Trial
Official title:
The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
| Verified date | March 2022 |
| Source | Ionis Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Ionis Pharmaceuticals, Inc. | Akcea Therapeutics |
United States, Canada, France, Germany, Netherlands, United Kingdom,
| 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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