Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT01229566

Run by

Trygg Pharma, Inc.

People needed

240

Starts

2010-10-01

Expected to finish

2012-07-01

Last updated by the study team

2011-11-24

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Illinois Recruiting — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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