Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
The primary objective is to determine the efficacy of AKR963 compared to placebo and active
 comparator in lowering fasting triglyceride levels in patients with very high fasting
 triglyceride levels ≥ 500 and ≤ 1500 mg/dL.
Increases in triglyceride concentrations have been correlated with increased risk for
 pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates
 for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with
 baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in
 the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799
 mg/dL (Assmann 1996).
Inclusion Criteria:

 -  Men and women, ages 18-79

 -  Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL

 -  Provide written informed consent and authorization for protected health information
 disclosure

 Exclusion Criteria:

 -  Women who are pregnant or lactating, or planning to become pregnant

 -  Use of non-statin lipid-altering drugs which cannot be stopped or other supplements
 with potential lipid-altering effects

 -  History of pancreatitis

 -  History of bariatric surgery or currently on weight loss drugs or in weight loss
 programs

 -  Treatment with any agent that may affect lipid levels or hepatic function

 -  Consumption of more than 3 alcoholic beverages per day

 -  History of cancer within last 2 years

 -  Participation in another clinical trial involving an investigational agent in the last
 30 days

 -  Other parameters will be assessed at the study center to ensure eligibility for this
 study