Trial · NCT02658175
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
NCT02658175, Phase 3, Completed, Akcea Therapeutics; results first posted 2021-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome. Trials, record NCT02658175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02658175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
- NCT number
- NCT02658175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- Akcea Therapeutics
- Conditions
- Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
- Interventions
- Volanesorsen
- First posted
- 2016-01-18
- Last updated
- 2021-08-26
- Other registries' IDs
- eudract:2015-003755-21
- Results first posted
- 2021-08-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change From Baseline in Fasting Triglyceride (TG) | Baseline and Months 3, 6, and 12 | Baseline for treatment-naïve group was defined as the average of open-label Day 1 pre-dose assessment and the last measurement prior to open-label Day 1. Baseline for CS6-volanesorsen and CS16-volanesorsen arm groups was defined as the average of index study Day 1 pre-dose assessment and the last measurement prior index study Day 1. The values at the Month 3 analysis time point were defined as the average of the Week 12 (Day 78) and Week 13 (Day 85) fasting assessments. The Month 6 analysis time point was at the end of Month 6, and the values were defined as the average of the Week 25 (Day 169) and Week 26 (Day 176) fasting assessments. The values at the Month 12 analysis time point were defined as the average of the Week 50 (Day 344) and Week 52 (Day 358) fasting assessments. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug to end of follow-up period [Up to Week 182] | An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. A TEAE was defined as any AE starting or getting worse on or after the first dose of the study drug. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change From Baseline in Fasting Triglyceride (TG) | Baseline and Months 3, 6, and 12 | FAS included all participants who were enrolled and received at least one dose of study drug and who had an open-label study baseline TG assessment. Here, number analyzed signifies participants evaluable for this outcome measure at specified time points. | percent change | MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug to end of follow-up period [Up to Week 182] | Safety Set included all participants who were enrolled and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | Treatment-naïve Group | Percent Change at Month 3 | -59.8 | Standard Deviation 37.0 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | CS6-Volanesorsen | Percent Change at Month 3 | -49.2 | Standard Deviation 34.8 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | CS16-Volanesorsen | Percent Change at Month 3 | -64.9 | Standard Deviation 9.1 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | Treatment-naïve Group | Percent Change at Month 6 | -45.5 | Standard Deviation 42.9 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | CS6-Volanesorsen | Percent Change at Month 6 | -54.8 | Standard Deviation 23.8 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | CS16-Volanesorsen | Percent Change at Month 6 | -43.0 | Standard Deviation 19.7 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | Treatment-naïve Group | Percent Change at Month 12 | -36.3 | Standard Deviation 44.2 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | CS6-Volanesorsen | Percent Change at Month 12 | -35.1 | Standard Deviation 45.6 | percent change |
| Mean Percent Change From Baseline in Fasting Triglyceride (TG) | CS16-Volanesorsen | Percent Change at Month 12 | -41.6 | Standard Deviation 36.3 | percent change |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-naïve Group | 51 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period: Weeks 1 to 52 | STARTED | Treatment-naïve Group | 51 | |
| Treatment Period: Weeks 1 to 52 | STARTED | CS6-Volanesorsen | 14 | |
| Treatment Period: Weeks 1 to 52 | STARTED | CS16-Volanesorsen | 3 | |
| Treatment Period: Weeks 1 to 52 | COMPLETED | Treatment-naïve Group | 36 | |
| Treatment Period: Weeks 1 to 52 | COMPLETED | CS6-Volanesorsen | 7 | |
| Treatment Period: Weeks 1 to 52 | COMPLETED | CS16-Volanesorsen | 3 | |
| Treatment Period: Weeks 1 to 52 | NOT COMPLETED | Treatment-naïve Group | 15 | |
| Treatment Period: Weeks 1 to 52 | NOT COMPLETED | CS6-Volanesorsen | 7 | |
| Treatment Period: Weeks 1 to 52 | NOT COMPLETED | CS16-Volanesorsen | 0 | |
| 1st Extended Treatment: Weeks 53 to 104 | STARTED | Treatment-naïve Group | 36 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events429
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 | Treatment-naïve Group | 36 | 51 | |
| other | Injection site erythema | General disorders | CS6-Volanesorsen | 7 | 14 | |
| other | Injection site erythema | General disorders | CS16-Volanesorsen | 1 | 3 | |
| other | Injection site pain | General disorders | Treatment-naïve Group | 21 | 51 | |
| other | Injection site pain | General disorders | CS6-Volanesorsen | 3 | 14 | |
| other | Injection site pain | General disorders | CS16-Volanesorsen | 0 | 3 | |
| other | Injection site swelling | General disorders | Treatment-naïve Group | 14 | 51 | |
| other | Injection site swelling | General disorders | CS6-Volanesorsen | 5 | 14 | |
| other | Injection site swelling | General disorders | CS16-Volanesorsen | 0 | 3 | |
| other | Injection site pruritus | General disorders | Treatment-naïve Group | 11 | 51 |
1 to 10 of 429Source ClinicalTrials.gov
See all 429 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment-naïve Group | 0 | 51 |
| Total, all-cause mortality | CS6-Volanesorsen | 0 | 14 |
| Total, all-cause mortality | CS16-Volanesorsen | 0 | 3 |
| Total, other adverse events | Treatment-naïve Group | 51 | 51 |
| Total, other adverse events | CS6-Volanesorsen | 14 | 14 |
| Total, other adverse events | CS16-Volanesorsen | 3 | 3 |
| Total, serious adverse events | Treatment-naïve Group | 13 | 51 |
| Total, serious adverse events | CS6-Volanesorsen | 2 | 14 |
| Total, serious adverse events | CS16-Volanesorsen | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02658175
GET https://conductscience.org/api/trials/v1/NCT02658175/flow?page=2