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Volanesorsen in Severe Hypertriglyceridemia (COMPASS)
NCT02300233Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2015
- Primary completion
- Jul 2016
- Countries
- 6
- Sponsor
- Ionis Pharmaceuticals
- Drugs
- volanesorsen
- Conditions
- hypertriglyceridemia
01
Overview
Phase 3, randomised, double-blind trial of volanesorsen in hypertriglyceridemia (3 arms), sponsored by Ionis Pharmaceuticals. Primary endpoint: Percent Change in Fasting Triglycerides From Baseline to Month 3. Started Feb 2015; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen Weekly
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Volanesorsen Biweekly (Post Week 13)
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
03
Who it enrols
Adults with fasting triglycerides ≥ 500 mg/dL and BMI ≤ 45 kg/m2, excluding those with T1DM, poorly controlled T2DM, or recent major cardiovascular/pancreatic events.
04
Endpoints
Primary
Percent Change in Fasting Triglycerides From Baseline to Month 3
Secondary
Absolute Change in Fasting Triglycerides 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 From Baseline
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance
Change From Baseline in Glycated Hemoglobin in Type 2 Diabetes Mellitus Participants
05
Results
Primary endpoints met
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