Severe Hypertriglyceridemia Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01208961 -
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
|
Phase 2 | |
| Completed |
NCT04541186 -
Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
|
Phase 2 | |
| Recruiting |
NCT05079919 -
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
|
Phase 3 | |
| Completed |
NCT02189252 -
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
|
Phase 1 | |
| Active, not recruiting |
NCT01229566 -
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
|
Phase 3 | |
| Completed |
NCT03001817 -
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
|
Phase 3 | |
| Completed |
NCT03011450 -
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT05355402 -
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
|
Phase 2 | |
| Completed |
NCT04720534 -
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
|
Phase 2 | |
| Not yet recruiting |
NCT06347016 -
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
|
Phase 3 | |
| Not yet recruiting |
NCT06347003 -
Phase 3 Study of Plozasiran in Adults With Severe Hypertriglyceridemia
|
Phase 3 | |
| Withdrawn |
NCT04662528 -
Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL
|
Phase 3 | |
| Recruiting |
NCT05852431 -
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
|
Phase 3 | |
| Completed |
NCT01242527 -
Epanova® for Lowering Very High Triglycerides
|
Phase 2/Phase 3 | |
| Completed |
NCT02944383 -
A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
|
Phase 2 | |
| Recruiting |
NCT05681351 -
A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
|
Phase 3 | |
| Recruiting |
NCT05552326 -
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
|
Phase 3 |