Familial Chylomicronemia SyndromePhase 3NCT02211209

The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

A Phase 3 study testing Volanesorsen in people with Familial Chylomicronemia Syndrome, run by Ionis Pharmaceuticals, Inc. at 40 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Familial Chylomicronemia Syndrome
What is being tested?: Volanesorsen
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 40 sitesin 12 countries
Study dates: Dec 2014to 28 Mar 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of chylomicronemia
A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening

Who cannot join

Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
Other types of severe hypertriglyceridemia
Active pancreatitis within 4 weeks of screening
Acute Coronary Syndrome within 6 months of screening
Major surgery within 3 months of screening
Treatment with Glybera therapy within 2 years of screening
Previous treatment with IONIS-APOCIIIRx
Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study

Trial locations and contacts

40 sites in 12 countries.

Country

City, postcode or hospital

40 sites in 12 countries

United States11 sites

IONIS Investigative Site
Boston, Massachusetts, 02114
IONIS Investigative Site
Encinitas, California, 92024
IONIS Investigative Site
Houston, Texas, 77030
IONIS Investigative Site
Kansas City, Kansas, 66214
IONIS Investigative Site
New York, New York, 10016
IONIS Investigative Site
Norfolk, Virginia, 23510
IONIS Investigative Site
Oklahoma City, Oklahoma, 73103
IONIS Investigative Site
Philadelphia, Pennsylvania, 19104
IONIS Investigative Site
Portland, Oregon, 97239
IONIS Investigative Site
San Francisco, California, 94143
IONIS Investigative Site
Seattle, Washington, 98104

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Spain6 sites

IONIS Investigative Site
A Coruña, Galicia, 15001
IONIS Investigative Site
Barcelona, 08036
IONIS Investigative Site
Madrid, 28007
IONIS Investigative Site
Málaga, 29010
IONIS Investigative Site
Seville, 41013
IONIS Investigative Site
Zaragoza, Aragon, 50009

Other trials in Spain

United Kingdom4 sites

IONIS Investigative Site
Birmingham, B9 5SS
IONIS Investigative Site
Manchester, M13 9WL
IONIS Investigative Site
Manchester, M23 9LT
IONIS Investigative Site
Peterborough, PE3 9GZ

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Brazil3 sites

IONIS Investigative Site
Campinas, 13059-740
IONIS Investigative Site
São Paulo, 04039-030
IONIS Investigative Site
São Paulo, 05403-000

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Canada3 sites

IONIS Investigative Site
Chicoutimi, Quebec, G7H 5H6
IONIS Investigative Site
Sainte-Foy, Quebec, G1V 4M6
IONIS Investigative Site
Vancouver, British Columbia, V6Z1Y6

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France3 sites

IONIS Investigative Site
Marseille, 13385
IONIS Investigative Site
Nantes, 44093
IONIS Investigative Site
Paris, 75013

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Italy3 sites

IONIS Investigative Site
Milan, 20162
IONIS Investigative Site
Palermo, 90127
IONIS Investigative Site
Rome, 00161

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Germany2 sites

IONIS Investigative Site
Berlin, 13353
IONIS Investigative Site
Dresden, 01307

Other trials in Germany

Netherlands2 sites

IONIS Investigative Site
Amsterdam, 1105 AZ
IONIS Investigative Site
Rotterdam, 3000

Other trials in Netherlands

Hungary1 site

IONIS Investigative Site
Szikszó, 3800

Other trials in Hungary

Israel1 site

IONIS Investigative Site
Safed, 13110

Other trials in Israel

South Africa1 site

IONIS Investigative Site
Cape Town, 7925

Other trials in South Africa

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

Conditions: Familial Chylomicronemia Syndrome
Being tested: Volanesorsen, Placebo
Medical subject headings: Familial hyperchylomicronemia syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VolanesorsenDrug
Also called ISIS 304801, ApoC-III, Approach, IONIS-APOCIIIRx
PlaceboDrug

Study groups in NCT02211209
Study group	Role	What they receive
Placebo	Placebo comparator	Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks. Receives: Drug: Placebo
Volanesorsen	Experimental	Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks. Receives: Drug: Volanesorsen

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Measured: Baseline to 3 months

Secondary outcomes (7)

Change From Baseline in Postprandial TG Area Under the Curve (AUC)(0-9h)
Participants had 2 postprandial assessments - one at Baseline (completed at least 48 hours prior to first dose) and one at any time between Week 13 and 19, inclusive. Assessment timepoints include from 1-hr before to up to 9 hrs after ingestion of the meal at 1-hour interval. Postprandial AUC results were calculated using a linear trapezoidal rule for each postprandial measure in the subset of participants who had postprandial assessments 0-9 hour results at baseline and the postbaseline between Week 13 to 19.
Measured: Baseline to an on-treatment assessment between Week 13 and Week 19
Absolute Change From Baseline in Fasting TG at Month 3
The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Measured: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting Plasma TG < 750 mg/dL at Month 3
The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments. mg/dL = milligrams per deciliter
Measured: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Measured: Baseline to 3 months
Frequency and Severity of Participant-reported Abdominal Pain During the Treatment Period
Abdominal pain was measured according to the Bracket electronic patient-reported outcomes (ePRO) assessment. Scores were categorized as follows: no pain (pain score: 0), mild (pain score: 1-3), moderate (pain score: 4-6), or severe (pain score: 7-10). The yearly frequency was calculated as the number of episodes during the on-treatment period / (last dose date - first dose date + 28) * 365.25. Missing data were imputed by using next observation carried back (NOCB) if there was a subsequent score available.
Measured: Baseline to 12 months
Frequency of the Composite of Episodes of Acute Pancreatitis and Participant-reported Moderate/Severe Abdominal Pain During the Treatment Period
Moderate/severe abdominal pain was defined as having a pain score of 4-10 on the Bracket electronic patient-reported outcomes (ePRO) assessment. Scores were categorized as follows: no pain (pain score: 0), mild (pain score: 1-3), moderate (pain score: 4-6), or severe (pain score: 7-10). The yearly frequency was calculated as the number of episodes during the on-treatment period / (last dose date - first dose date + 28) * 365.25.
Measured: 12 months
Change From Baseline in Hepatosplenomegaly as Assessed by MRI at Week 52
The Week 52 endpoint was defined as the average of Week 50 (Day 344)/Week 51 (Day 351) and Week 52 (Day 358) fasting assessments.
Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201428 Mar 2017

First posted7 Aug 2014 (estimated)
Study startDec 2014
Primary completion19 Dec 2016
Study completion28 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Familial Chylomicronemia SyndromeStudies of the same condition, open and under way.
More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02211209
Sponsor's protocol ID: ISIS 304801-CS6
Other IDs: 2014-002421-35, 2014
Status last verified: Mar 2022
First submitted: 5 Aug 2014
Last updated: 13 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Witztum JL, Gaudet D, Freedman SD, Alexander VJ, Digenio A, Williams KR, Yang Q, Hughes SG, Geary RS, Arca M, Stroes ESG, Bergeron J, Soran H, Civeira F, Hemphill L, Tsimikas S, Blom DJ, O'Dea L, Bruckert E. Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome. N Engl J Med. 2019 Aug 8;381(6):531-542. doi: 10.1056/NEJMoa1715944.
PubMed 31390500
Prohaska TA, Alexander VJ, Karwatowska-Prokopczuk E, Tami J, Xia S, Witztum JL, Tsimikas S. APOC3 inhibition with volanesorsen reduces hepatic steatosis in patients with severe hypertriglyceridemia. J Clin Lipidol. 2023 May-Jun;17(3):406-411. doi: 10.1016/j.jacl.2023.04.007. Epub 2023 Apr 27.
PubMed 37164837
Hegele RA, Berberich AJ, Ban MR, Wang J, Digenio A, Alexander VJ, D'Erasmo L, Arca M, Jones A, Bruckert E, Stroes ES, Bergeron J, Civeira F, Witztum JL, Gaudet D. Clinical and biochemical features of different molecular etiologies of familial chylomicronemia. J Clin Lipidol. 2018 Jul-Aug;12(4):920-927.e4. doi: 10.1016/j.jacl.2018.03.093. Epub 2018 Apr 4.
PubMed 29748148
Digenio A, Dunbar RL, Alexander VJ, Hompesch M, Morrow L, Lee RG, Graham MJ, Hughes SG, Yu R, Singleton W, Baker BF, Bhanot S, Crooke RM. Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes. Diabetes Care. 2016 Aug;39(8):1408-15. doi: 10.2337/dc16-0126. Epub 2016 Jun 6.
PubMed 27271183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants
Familial Chylomicronemia Syndrome
RecruitingEarly Phase 1
CS-121 APOC3 Base Editing in FCS
Familial Chylomicronemia Syndrome (FCS)
Active, not recruitingPhase 1/2
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
Hypertriglyceridemia, Familial Chylomicronemia Syndrome
Active, not recruitingPhase 3
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen
Familial Chylomicronemia Syndrome
Active, not recruitingPhase 3
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
Familial Chylomicronemia Syndrome

All Familial Chylomicronemia Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
ClinicalTrials.gov ID: NCT02211209
Acronym / sponsor ID: ISIS 304801-CS6
Conditions: Familial Chylomicronemia Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Akcea Therapeutics
Study start: Dec 2014 (actual)
Primary completion: 19 Dec 2016 (actual)
Study completion: 28 Mar 2017 (actual)
First posted: 7 Aug 2014 (estimated)
Results: Posted 13 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboVolanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks.
Volanesorsen	Experimental	Drug: VolanesorsenVolanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

History of chylomicronemia
A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening

Key exclusion criteria (8 listed)

Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
Other types of severe hypertriglyceridemia
Active pancreatitis within 4 weeks of screening
Acute Coronary Syndrome within 6 months of screening
Major surgery within 3 months of screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VolanesorsenAlso: ISIS 304801, ApoC-III, Approach, IONIS-APOCIIIRx	Drug	Volanesorsen
Placebo	Drug	Placebo

Primary outcome

Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
Time frame: Baseline to 3 months
The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.

7 secondary outcomes

Change From Baseline in Postprandial TG Area Under the Curve (AUC)(0-9h)
Time frame: Baseline to an on-treatment assessment between Week 13 and Week 19
Absolute Change From Baseline in Fasting TG at Month 3
Time frame: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting Plasma TG < 750 mg/dL at Month 3
Time frame: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Time frame: Baseline to 3 months
Frequency and Severity of Participant-reported Abdominal Pain During the Treatment Period
Time frame: Baseline to 12 months
Frequency of the Composite of Episodes of Acute Pancreatitis and Participant-reported Moderate/Severe Abdominal Pain During the Treatment Period
Time frame: 12 months
Change From Baseline in Hepatosplenomegaly as Assessed by MRI at Week 52
Time frame: Baseline to Week 52

Results and safety

Results posted to the registry on 13 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	34	32
Volanesorsen	33	19

Primary outcome: Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3

Time frame: Baseline to 3 months. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	Placebo n = 33	Volanesorsen n = 33
Value	17.6 (-4.0 to 39.2)	-76.5 (-97.4 to -55.5)

Placebo vs Volanesorsen: Least Squares Mean Difference: -94.1 (95% CI -121.7 to -66.6), p < 0.0001, ANCOVA

Population analysed: The full analysis set included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 65 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 33 (15.2%)	27 of 33 (81.8%)	0 of 33
Volanesorsen	7 of 33 (21.2%)	32 of 33 (97%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31390500Witztum JL, Gaudet D, Freedman SD, Alexander VJ, Digenio A, Williams KR, Yang Q, Hughes SG, Geary RS, Arca M, Stroes ESG, Bergeron J, Soran H, Civeira F, Hemphill L, Tsimikas S, Blom DJ, O'Dea L, Bruckert E. Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome. N Engl J Med. 2019 Aug 8;381(6):531-542. doi: 10.1056/NEJMoa1715944.
Derived from this study: PubMed 37164837Prohaska TA, Alexander VJ, Karwatowska-Prokopczuk E, Tami J, Xia S, Witztum JL, Tsimikas S. APOC3 inhibition with volanesorsen reduces hepatic steatosis in patients with severe hypertriglyceridemia. J Clin Lipidol. 2023 May-Jun;17(3):406-411. doi: 10.1016/j.jacl.2023.04.007. Epub 2023 Apr 27.
Derived from this study: PubMed 29748148Hegele RA, Berberich AJ, Ban MR, Wang J, Digenio A, Alexander VJ, D'Erasmo L, Arca M, Jones A, Bruckert E, Stroes ES, Bergeron J, Civeira F, Witztum JL, Gaudet D. Clinical and biochemical features of different molecular etiologies of familial chylomicronemia. J Clin Lipidol. 2018 Jul-Aug;12(4):920-927.e4. doi: 10.1016/j.jacl.2018.03.093. Epub 2018 Apr 4.
Derived from this study: PubMed 27271183Digenio A, Dunbar RL, Alexander VJ, Hompesch M, Morrow L, Lee RG, Graham MJ, Hughes SG, Yu R, Singleton W, Baker BF, Bhanot S, Crooke RM. Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes. Diabetes Care. 2016 Aug;39(8):1408-15. doi: 10.2337/dc16-0126. Epub 2016 Jun 6.
Individual participant dataSharing planned: No

Related trials for Familial Chylomicronemia Syndrome

RecruitingPhase 3
A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants
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RecruitingEarly Phase 1
CS-121 APOC3 Base Editing in FCS
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Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

40 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Volanesorsen in people with Familial Chylomicronemia Syndrome, run by Ionis Pharmaceuticals, Inc. at 40 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, United Kingdom, Brazil, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02211209, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.