Trial · NCT02300233
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
NCT02300233, Phase 3, Completed, Ionis Pharmaceuticals, Inc.; results first posted 2022-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia. Trials, record NCT02300233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02300233
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
- NCT number
- NCT02300233
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 114 participants, actual
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Conditions
- Hypertriglyceridemia
- Interventions
- Volanesorsen, Placebo
- First posted
- 2014-11-24
- Last updated
- 2022-04-13
- Other registries' IDs
- eudract:2014-003434-93
- Results first posted
- 2022-04-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline to 3 months | mg/dL = milligrams per deciliter |
| Secondary | Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR) | Baseline to 3 and 6 months | 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. |
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants | Baseline to 3 and 6 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 | Baseline to 3 months | The full analysis set (FAS) included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Fasting TG From Baseline to Month 3 | Baseline to 3 months | The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Volanesorsen 300 mg biweekly group includes patients who received weekly dosing in first 13 weeks, and then bi-weekly for 13 weeks. For month 3 assessments, the results were combined since all patients were on weekly dosing. And for month 6 assessments, the results were split to show the results in each dosing group. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3 | Baseline to 3 months | The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline | Baseline to 3 months | The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 | Baseline to 3 months | The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR) | Baseline to 3 and 6 months | The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Number analyzed were the participants evaluated at the given time point. | score | MEAN |
| SECONDARY | Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants | Baseline to 3 and 6 months | The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Number analyzed were the T2DM participants evaluated at the given time point. | percentage | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 | Placebo | -0.9 | 95% Confidence Interval -13.9 to 12.2 | percent change | |
| Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 | Volanesorsen Total | -71.2 | 95% Confidence Interval -79.3 to -63.2 | percent change | |
| Absolute Change in Fasting TG From Baseline to Month 3 | Placebo | 74 | 95% Confidence Interval -138 to 285 | mg/dL | |
| Absolute Change in Fasting TG From Baseline to Month 3 | Volanesorsen Total | -869 | 95% Confidence Interval -1018 to -720 | mg/dL | |
| Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3 | Placebo | 5 | Participants | ||
| Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3 | Volanesorsen Total | 65 | Participants | ||
| Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline | Placebo | 4.4 | 95% Confidence Interval -5.2 to 14.0 | percent change | |
| Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline | Volanesorsen Total | 61.2 | 95% Confidence Interval 54.2 to 68.3 | percent change | |
| Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 | Placebo | 0 | Participants | ||
| Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 | Volanesorsen Total | 11 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | STARTED | Volanesorsen 300 mg Weekly | 25 | |
| Overall Study | STARTED | Volanesorsen 300 mg Biweekly, Post Week 13 | 50 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | COMPLETED | Volanesorsen 300 mg Weekly | 24 | |
| Overall Study | COMPLETED | Volanesorsen 300 mg Biweekly, Post Week 13 | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Volanesorsen 300 mg Weekly | 1 | |
| Overall Study | NOT COMPLETED | Volanesorsen 300 mg Biweekly, Post Week 13 | 23 |
Source ClinicalTrials.gov
Adverse events225
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Placebo | 2 | 38 | |
| other | Injection site erythema | General disorders | Volanesorsen 300 mg Weekly | 23 | 25 | |
| other | Injection site erythema | General disorders | Volanesorsen 300 mg Biweekly, Post Week 13 | 38 | 50 | |
| other | Injection site pain | General disorders | Placebo | 2 | 38 | |
| other | Injection site pain | General disorders | Volanesorsen 300 mg Weekly | 10 | 25 | |
| other | Injection site pain | General disorders | Volanesorsen 300 mg Biweekly, Post Week 13 | 29 | 50 | |
| other | Injection site swelling | General disorders | Placebo | 1 | 38 | |
| other | Injection site swelling | General disorders | Volanesorsen 300 mg Weekly | 12 | 25 | |
| other | Injection site swelling | General disorders | Volanesorsen 300 mg Biweekly, Post Week 13 | 24 | 50 | |
| other | Injection site pruritus | General disorders | Placebo | 0 | 38 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, all-cause mortality | Volanesorsen 300 mg Weekly | 0 | 25 |
| Total, all-cause mortality | Volanesorsen 300 mg Biweekly, Post Week 13 | 0 | 50 |
| Total, other adverse events | Placebo | 31 | 38 |
| Total, other adverse events | Volanesorsen 300 mg Weekly | 24 | 25 |
| Total, other adverse events | Volanesorsen 300 mg Biweekly, Post Week 13 | 49 | 50 |
| Total, serious adverse events | Placebo | 4 | 38 |
| Total, serious adverse events | Volanesorsen 300 mg Weekly | 2 | 25 |
| Total, serious adverse events | Volanesorsen 300 mg Biweekly, Post Week 13 | 6 | 50 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Volanesorsen Total vs Placebo: Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3 | Trial comparisons |
| Volanesorsen Total vs Placebo: Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02300233
GET https://conductscience.org/api/trials/v1/NCT02300233/results?page=2