HypertriglyceridemiaPhase 2NCT01529424
Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia
A Phase 2 study testing ISIS apoC-III Rx in people with Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- ISIS apoC-III Rx
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2012to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Severe hypertriglyceridemia
Who cannot join
- HbA1c >/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year
- Body mass index (BMI) >40 kg/m2
- History of bariatric surgery or currently on weight loss drugs
- Use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing
- Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. Group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period.
- Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with potential lipid-altering effects unless dose is stable and well controlled for 30 days prior to dosing
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- Any Screening laboratory values that are out of allowed reference ranges
- Inability to comply with protocol or study procedures
- Any other significant illness or condition that may adversely affect the subjects participation in the study
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Farmville Internal Medicine
Farmville, North Carolina, 27828
Mark R. Cervi
Greenville, North Carolina, 27834
Physicians East, Quadrangle Medical Specialists
Greenville, North Carolina, 27834
Carolina East Family Medicine
Greenville, North Carolina, 27858
Eastern Carolina Physicians
Kinston, North Carolina, 28504
Natalie A Doyle, MD PA
Wilson, North Carolina, 27893
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Response, Phase 2 Study of ISIS 304801 Administered Subcutaneously to Patients With Severe or Uncontrolled Hypertriglyceridemia
The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels.
- Conditions
- Hypertriglyceridemia
- Being tested
- ISIS apoC-III Rx, Placebo
- Keywords
- Hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS apoC-III RxDrug
Dose 1
ISIS apoC-III RxDrug
Dose 2
ISIS apoC-III RxDrug
Dose 3
PlaceboDrug
Dose 1
PlaceboDrug
Dose 2
PlaceboDrug
Dose 3
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Non-extensive PK/non post-prandial Receives: Drug: ISIS apoC-III Rx; Drug: Placebo |
| Group 2a | Experimental | Extensive PK Receives: Drug: ISIS apoC-III Rx; Drug: Placebo |
| Group 2b | Experimental | Post-prandial assessment Receives: Drug: ISIS apoC-III Rx; Drug: Placebo |
| Group 3 | Experimental | Stable dose of fibrate Receives: Drug: ISIS apoC-III Rx; Drug: Placebo |
| Group 4 | Experimental | Fredrickson Type 1 dyslipidemia Receives: Drug: ISIS apoC-III Rx |
What is being measured
The primary outcome is the main question the study is designed to answer.
VLDL apoC-III
The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.
Measured: 92 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529424
- Sponsor's protocol ID
- ISIS 304801-CS2
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2012
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaudet D, Alexander VJ, Baker BF, Brisson D, Tremblay K, Singleton W, Geary RS, Hughes SG, Viney NJ, Graham MJ, Crooke RM, Witztum JL, Brunzell JD, Kastelein JJ. Antisense Inhibition of Apolipoprotein C-III in Patients with Hypertriglyceridemia. N Engl J Med. 2015 Jul 30;373(5):438-47. doi: 10.1056/NEJMoa1400283.
PubMed 26222559
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Response, Phase 2 Study of ISIS 304801 Administered Subcutaneously to Patients With Severe or Uncontrolled Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01529424
- Acronym / sponsor ID
- ISIS 304801-CS2
- Conditions
- Hypertriglyceridemia
- Keywords
- Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
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 dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ISIS apoC-III Rx, Drug: PlaceboNon-extensive PK/non post-prandial |
| Group 2a | Experimental | Drug: ISIS apoC-III Rx, Drug: PlaceboExtensive PK |
| Group 2b | Experimental | Drug: ISIS apoC-III Rx, Drug: PlaceboPost-prandial assessment |
| Group 3 | Experimental | Drug: ISIS apoC-III Rx, Drug: PlaceboStable dose of fibrate |
| Group 4 | Experimental | Drug: ISIS apoC-III RxFredrickson Type 1 dyslipidemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe hypertriglyceridemia
Key exclusion criteria (9 listed)
- HbA1c >/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year
- Body mass index (BMI) >40 kg/m2
- History of bariatric surgery or currently on weight loss drugs
- Use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing
- Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. Group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period.
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 |
|---|---|---|
| ISIS apoC-III RxDose 1 | Drug | Group 1, Group 2a |
| ISIS apoC-III RxDose 2 | Drug | Group 1, Group 2a, Group 2b, Group 3 |
| ISIS apoC-III RxDose 3 | Drug | Group 1, Group 2a, Group 2b, Group 3, Group 4 |
| PlaceboDose 1 | Drug | Group 1, Group 2a |
| PlaceboDose 2 | Drug | Group 1, Group 2a, Group 2b, Group 3 |
| PlaceboDose 3 | Drug | Group 1, Group 2a, Group 2b, Group 3 |
Primary outcome
VLDL apoC-III
Time frame: 92 Days
The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 26222559Gaudet D, Alexander VJ, Baker BF, Brisson D, Tremblay K, Singleton W, Geary RS, Hughes SG, Viney NJ, Graham MJ, Crooke RM, Witztum JL, Brunzell JD, Kastelein JJ. Antisense Inhibition of Apolipoprotein C-III in Patients with Hypertriglyceridemia. N Engl J Med. 2015 Jul 30;373(5):438-47. doi: 10.1056/NEJMoa1400283.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS apoC-III Rx in people with Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 7 sites in 2 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 1 inclusion and 9 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VLDL apoC-III (time frame: 92 Days). 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 NCT01529424, which also lists 1 linked publication.
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 27 Jan 2022.