Phase 3
Completed N=113
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Source: ClinicalTrials.gov NCT02300233 ↗Enrolled (actual)
113
Serious AEs
10.6%
Results posted
Apr 2022
Primary outcomePrimary: Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 — -0.9; -71.2 percent change — p=<0.0001
◆ Published Evidence
Highly cited
226citations · ~45 / year
Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
Summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
Linked Publications (2)
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Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
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APOC3 inhibition with volanesorsen reduces hepatic steatosis in patients with severe hypertriglyceridemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 |
-0.9; -71.2 | <0.0001 sig |
| SECONDARY Absolute Change in Fasting TG From Baseline to Month 3 |
74; -869 | <0.0001 sig |
| SECONDARY Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3 |
5; 65 | <0.0001 sig |
| SECONDARY Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline |
4.4; 61.2 | <0.0001 sig |
| SECONDARY Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 |
0; 11 | 0.0474 sig |
| SECONDARY Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR) |
-0.29; 1.53; -0.45; -0.37; 1.54; 0.56 | — |
| SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants |
-0.0; 0.4; 0.1; -0.2; 0.8; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) ≤ 45 kg/m2
- Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
- 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
- Type 1 diabetes mellitus
- Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening
- Acute pancreatitis within 3 months of screening
- Acute Coronary Syndrome within 6 months of screening
- Major surgery within 3 months of screening
- Prior exposure to ISIS 304801
- Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study
Data sourced from ClinicalTrials.gov (NCT02300233) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.