Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trygg Pharma, Inc.

Criteria

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