Triglycerides – molecules that transport fat in the bloodstream – have been shown to play a role in cardiovascular disease. That is why the mechanisms that control triglycerides are now the target for a new clinical trial at Baylor College of Medicine looking to lower high triglyceride levels in people diagnosed with cardiovascular disease.  

The study to examine the efficacy of different doses and dose regimens of a drug called AKCEA-APOCIII-LRx currently is enrolling participants.

Statins are the traditional and most effective way to treat high LDL cholesterol, but even when target levels are reached, in some individuals triglycerides may remain high. Triglycerides are a type of fat rich in energy that is carried in lipid particles in blood and also stored in fat cells. Levels of less than 150 mg/dL are considered healthy, and more than 200 mg/dL are high. In past studies, it has been shown that triglyceride levels are associated with both short-term and long-term risks for cardiovascular disease events even with the use of statins and lifestyle modifications.

The therapeutic AKCEA-APOCIII-LRx targets apolipoprotein C-III (apoC-III), which is a protein synthesized primarily by the liver that helps to regulate triglyceride levels. Elevated levels of apoC-III increase triglyceride levels. This treatment uses a new technology called anti-sense that has been designed to reduce the production of apoC-III protein

Researchers are looking for participants who:

  • Have been diagnosed with cardiovascular disease
  • Have fasting triglyceride levels between 200 mg/dL and 500 mg/dL at screening and qualification visit
  • Are on a preventative therapy for known cardiovascular disease risk factors

The trial is a randomized, double-blind, placebo-controlled, dose-ranging study. This means there will be four different groups receiving different dosages (amount and frequency) of the drug. Within each group some participants will randomly receive a placebo. Within each group, for every one participant randomized to placebo, four will be randomized to receive the study drug. The treatment will be administered by injection every four weeks, two weeks or weekly. Early studies have shown that the efficacy for this treatment could indicate a potential for monthly or less frequent dosing. 

Regularly used lipid modifying therapy will not be reduced or stopped during the course of the study. There will be no cost to participants.  

To learn more about this study, including additional criteria to join, please contact Sharon Goss sgoss@bcm.edu at 713-798-8800 or Terry Techmanski at maryt@bcm.edu or 713-798-5845. More information also can be found at clinicaltrial.gov.

The study is being sponsored by Akcea Therapeutics collaborating with Ionis Pharmaceuticals, Inc.