Severe HypertriglyceridemiaPhase 3NCT01997268
The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)
A Phase 3 study testing SC401B 2 capsules, SC401B 4 capsules and SC401B 6 capsules in people with Severe Hypertriglyceridemia, run by Sancilio and Company, Inc..
Trial summary
The purpose of this study is to investigate the effects of SC401B (ethyl esters of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypertriglyceridemia
- What is being tested?
- SC401B 2 capsules, SC401B 4 capsules and SC401B 6 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2014
- Phase
- Phase 3
- 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
- Be male or female, age 18 years
- Have a TG level ≥500 mg/dL and ≤2,000 mg
- Have the ability to understand the requirements of the study and be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions and return for the required assessments.
- Be normally active and in good health on the basis of medical history.
- Willing to maintain a stable diet and not alter their physical activity level throughout the study.
- Women of childbearing potential must be willing to use accepted birth control methods throughout the study.
Who cannot join
- Women who are pregnant, planning to become pregnant, or breastfeed during the study period
- History of pancreatitis
- Hemoglobin A1c > 9.5% (subjects with diabetes mellitus will be required to receive stable therapy)
- History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary vascularization within 6 months before screening
- Thyroid-stimulating hormone > 1.5 x upper limit of normal; clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for
- 6 weeks before screening
Show all 16Show fewer
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal
- An unexplained creatine kinase concentration > 3 x upper limit of normal or creatine kinase elevation due to known muscle disease (e.g., polymyositis, mitochondrial dysfunction)
- Blood donation of ≥1 pint within 30 days before screening or plasma donation within 7 days before screening
- The consumption of >2 alcoholic beverages per day after screening; a history of illicit drug use within 1 year before screening
- A history of symptomatic gallstone disease unless treated with cholecystectomy
- Known nephrotic syndrome or >3 g/day proteinuria
- Allergy or intolerance to omega-3 fatty acids, ethyl esters, or fish; known lipoprotein lipase impairment or deficiency or apoC-II deficiency or familial dysbetalipoproteinemia
- History of cancer (other than basal cell carcinoma of the skin) in the past 2 years; and a history or evidence of major and clinically significant disease that could adversely affect the conduct of the study or patient safety.
- Use acetylcholinesterase inhibitors or memantine, in the prior 2 months to screening
- Use of a lipase inhibitor such as Xenical (orlistat)
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled 12-Week Study to Determine the Efficacy of EPA+DHA (SC401B) on Hypertriglyceridemia (TG ≥ 500 mg/dL and ≤ 2000 mg/dL)
The purpose of this study is to investigate the effects of SC401B (ethyl esters of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain surfactants that may aid in the absorption of EPA and DHA. Based on the results of pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are bioavailable in both the fasted and fed states.
The protocol specified primary endpoint is the difference from the placebo group in the percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6 capsules of SC401B per day. The protocol specified secondary endpoints include percent changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein (Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2).
An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6 capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping, fishy taste, upset stomach, loose stools, stools with fishy smell or any other self-reported observations will be evaluated. Additional safety measures will include changes in liver enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6 capsules of SC401B and placebo.
- Conditions
- Severe Hypertriglyceridemia
- Being tested
- Placebo, SC401B 2 capsules, SC401B 4 capsules, SC401B 6 capsules
- Keywords
- Dyslipidemia, Hyperlipidemia, Omega-3 Fatty Acids, Metabolic Diseases, TG ≥500 mg/dL and ≤ 2,000 mg/dL
- Medical subject headings
- Hypertriglyceridemia, Dyslipidemias, Hyperlipidemias, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Corn Oil
SC401B 2 capsulesDrug
SC401B 4 capsulesDrug
SC401B 6 capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 6 capsules (1.24 g each) daily for 12 weeks Receives: Drug: Placebo |
| SC401B 2 capsules | Experimental | SC401B 2 capsules (1.24 g each) + 4 placebo capsules daily for 12 weeks Receives: Drug: SC401B 2 capsules |
| SC401B 4 capsules | Experimental | SC401B 4 capsules (1.24 g each) + 2 placebo capsules daily for 12 weeks Receives: Drug: SC401B 4 capsules |
| SC401B 6 capsules | Experimental | SC401B 6 capsules (1.24 g each) daily for 12 weeks Receives: Drug: SC401B 6 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Serum Triglycerides
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment (12 weeks) in triglyceride levels between placebo and 2, 4, and 6 capsules per day of SC401B.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Primary completionDec 2014
Why it stopped: Study never initiated. IND placed on Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HypertriglyceridemiaStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sancilio and Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Principal investigator, Biofortis Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997268
- Sponsor's protocol ID
- P-13-009
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2013
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled 12-Week Study to Determine the Efficacy of EPA+DHA (SC401B) on Hypertriglyceridemia (TG ≥ 500 mg/dL and ≤ 2000 mg/dL)
- ClinicalTrials.gov ID
- NCT01997268
- Acronym / sponsor ID
- P-13-009
- Conditions
- Severe Hypertriglyceridemia
- Keywords
- Dyslipidemia, Hyperlipidemia, Omega-3 Fatty Acids, Metabolic Diseases, TG ≥500 mg/dL and ≤ 2,000 mg/dL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never initiated. IND placed on Hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sancilio and Company, Inc.Industry (pharma, biotech, devices)
- Primary completion
- Dec 2014 (actual)
- First posted
- 28 Nov 2013 (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 investigate the effects of SC401B (ethyl esters of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain surfactants that may aid in the absorption of EPA and DHA. Based on the results of pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are bioavailable in both the fasted and fed states.
The protocol specified primary endpoint is the difference from the placebo group in the percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6 capsules of SC401B per day. The protocol specified secondary endpoints include percent changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein (Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2).
An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6 capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping, fishy taste, upset stomach, loose stools, stools with fishy smell or any other self-reported observations will be evaluated. Additional safety measures will include changes in liver enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6 capsules of SC401B and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 6 capsules (1.24 g each) daily for 12 weeks |
| SC401B 2 capsules | Experimental | Drug: SC401B 2 capsulesSC401B 2 capsules (1.24 g each) + 4 placebo capsules daily for 12 weeks |
| SC401B 4 capsules | Experimental | Drug: SC401B 4 capsulesSC401B 4 capsules (1.24 g each) + 2 placebo capsules daily for 12 weeks |
| SC401B 6 capsules | Experimental | Drug: SC401B 6 capsulesSC401B 6 capsules (1.24 g each) daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be male or female, age 18 years
- Have a TG level ≥500 mg/dL and ≤2,000 mg
- Have the ability to understand the requirements of the study and be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions and return for the required assessments.
- Be normally active and in good health on the basis of medical history.
- Willing to maintain a stable diet and not alter their physical activity level throughout the study.
Key exclusion criteria (16 listed)
- Women who are pregnant, planning to become pregnant, or breastfeed during the study period
- History of pancreatitis
- Hemoglobin A1c > 9.5% (subjects with diabetes mellitus will be required to receive stable therapy)
- History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary vascularization within 6 months before screening
- Thyroid-stimulating hormone > 1.5 x upper limit of normal; clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for
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 |
|---|---|---|
| PlaceboCorn Oil | Drug | Placebo |
| SC401B 2 capsules | Drug | SC401B 2 capsules |
| SC401B 4 capsules | Drug | SC401B 4 capsules |
| SC401B 6 capsules | Drug | SC401B 6 capsules |
Primary outcome
Fasting Serum Triglycerides
Time frame: 12 weeks
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment (12 weeks) in triglyceride levels between placebo and 2, 4, and 6 capsules per day of SC401B.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
Related trials for Severe Hypertriglyceridemia
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
RecruitingPhase 3
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Severe Hypertriglyceridemia
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Cardiovascular, Metabolic Disease
Active, not recruitingPhase 2
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis
Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
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.
Kevin C Maki, PhD principal investigator
Biofortis Clinical Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SC401B 2 capsules, SC401B 4 capsules and SC401B 6 capsules in people with Severe Hypertriglyceridemia, run by Sancilio and Company, Inc..
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fasting Serum Triglycerides (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.