HypertriglyceridemiaPhase 3NCT02300233
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
A Phase 3 study testing Volanesorsen in people with Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 45 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- 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
- 114 participants
- Where
- 45 sitesin 6 countries
- Study dates
- 5 Feb 2015to 24 Jan 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
- 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.
Who cannot join
- 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
Trial locations and contacts
45 sites in 6 countries.
45 sites in 6 countries
United States29 sites
IONIS Investigative Site
Benson, North Carolina, 27504
IONIS Investigative Site
Boca Raton, Florida, 33434
IONIS Investigative Site
Boston, Massachusetts, 02114
IONIS Investigative Site
Chapel Hill, North Carolina, 27609
IONIS Investigative Site
Cincinnati, Ohio, 45227
IONIS Investigative Site
Encinitas, California, 92024
IONIS Investigative Site
Farmville, North Carolina, 27828
IONIS Investigative Site
Grandville, Michigan, 49418
IONIS Investigative Site
Greenville, North Carolina, 27834
IONIS Investigative Site
Houston, Texas, 77030
IONIS Investigative Site
Kansas City, Kansas, 66160
IONIS Investigative Site
Kettering, Ohio, 45429
IONIS Investigative Site
Marion, Ohio, 43302
IONIS Investigative Site
Miami, Florida, 33147
IONIS Investigative Site
Morrisville, North Carolina, 27560
IONIS Investigative Site
Norfolk, Virginia, 23510
IONIS Investigative Site
North Massapequa, New York, 11758-1802
IONIS Investigative Site
Oklahoma City, Oklahoma, 73103
IONIS Investigative Site
Portland, Oregon, 97239
IONIS Investigative Site
Providence, Rhode Island, 02906
IONIS Investigative Site
Raleigh, North Carolina, 27612
IONIS Investigative Site
Salisbury, Maryland, 73103
IONIS Investigative Site
Salt Lake City, Utah, 84108
IONIS Investigative Site
San Francisco, California, 94143
IONIS Investigative Site
Seattle, Washington, 98104
IONIS Investigative Site
Sterling, Illinois, 61081
IONIS Investigative Site
Towson, Maryland, 21204
IONIS Investigative Site
Wilson, North Carolina, 27609
IONIS Investigative Site
Wilson, North Carolina, 27893
Canada4 sites
IONIS Investigative Site
Chicoutimi, Quebec, G7H 7K9
IONIS Investigative Site
London, Ontario, N6A 5B7
IONIS Investigative Site
Sainte-Foy, Quebec, G1V 4M6
IONIS Investigative Site
Vancouver, British Columbia, V6Z 1Y6
France4 sites
IONIS Investigative Site
Dijon, 21079
IONIS Investigative Site
Marseille, 13385
IONIS Investigative Site
Paris, 75013
IONIS Investigative Site
Saint-Herblain
Germany3 sites
IONIS Investigative Site
Berlin, 13353
IONIS Investigative Site
Cologne, North Rhine-Westphalia, 50937
IONIS Investigative Site
Dresden, 01307
Netherlands3 sites
IONIS Investigative Site
Amsterdam, North Holland, 1105 AZ
IONIS Investigative Site
Rotterdam, South Holland, 3045 PM
IONIS Investigative Site
Utrecht, 3584 CX
United Kingdom2 sites
IONIS Investigative Site
Manchester, M23 9LT
IONIS Investigative Site
Peterborough, PE3 6DA
About this study
Official title: The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
- Conditions
- Hypertriglyceridemia
- Being tested
- Volanesorsen, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolanesorsenDrug
Also called ISIS 304801
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
PlaceboDrug
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. Receives: Drug: Placebo |
| Volanesorsen 300 mg weekly | Experimental | Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. Receives: Drug: Volanesorsen |
| Volanesorsen 300 mg biweekly, post Week 13 | Experimental | Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 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
Measured: Baseline to 3 months
Secondary outcomes (6)
Absolute Change in Fasting TG From Baseline to Month 3
Measured: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Measured: Baseline to 3 months
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Measured: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
mg/dL = milligrams per deciliter
Measured: Baseline to 3 months
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
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.
Measured: Baseline to 3 and 6 months
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Measured: Baseline to 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start5 Feb 2015
- Primary completion27 Jul 2016
- Study completion24 Jan 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 (2)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akcea Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300233
- Sponsor's protocol ID
- ISIS 304801-CS16
- Other IDs
- 2014-003434-93, 2014
- Status last verified
- Mar 2022
- First submitted
- 20 Nov 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
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 37164837Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.
PubMed 33798466
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
- The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT02300233
- Acronym / sponsor ID
- ISIS 304801-CS16
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Akcea Therapeutics
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 24 Nov 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 26 weeks in participants with Hypertriglyceridemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboVolanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. |
| Volanesorsen 300 mg weekly | Experimental | Drug: VolanesorsenVolanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. |
| Volanesorsen 300 mg biweekly, post Week 13 | Experimental | Drug: VolanesorsenVolanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 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)
- 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.
Key exclusion criteria (7 listed)
- 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
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 304801300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks. | Drug | Volanesorsen 300 mg biweekly, post Week 13, Volanesorsen 300 mg weekly |
| PlaceboVolanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. | Drug | Placebo |
Primary outcome
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
Time frame: Baseline to 3 months
6 secondary outcomes
Absolute Change in Fasting TG From Baseline to 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
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Time frame: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
Time frame: Baseline to 3 months
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Time frame: Baseline to 3 and 6 months
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Time frame: Baseline to 3 and 6 months
Results and safety
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.
- 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 33798466Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.
- Individual participant dataSharing planned: No
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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.
45 sites in 6 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 Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 45 sites in 6 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 7 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 45 sites in United States, Canada, France, Germany, Netherlands and 1 more country. 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 NCT02300233, which also lists 2 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.