ISIS 304801-CS16 - The COMPASS Study
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Hypertriglyceridemia
IRAS ID
167949
Contact name
Steven Martin
Contact email
Sponsor organisation
Ionis Pharmaceuticals
Eudract number
2014-003434-93
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 4 days
Research summary
Severe hypertriglyceridemia is a common disease characterized by high levels of triglycerides (fatty substances) in the blood due to the body being unable to break down fats correctly. The disease is a result of genetic factors as well as secondary factors such as obesity, diabetes and excess alcohol. One of the major risks of high triglyceride levels is acute pancreatitis (inflammation of the pancreas) causing life threatening complications. Although hypertriglyceridemia mainly presents no symptoms, patients can experience nerve damage, eye abnormalities, and yellow deposits of fatty material on the skin (xanthomas) as the disease becomes more severe.
Current treatments for hypertriglyceridemia focus on a low-fat and alcohol-free diet to encourage weight loss and reduce symptoms of the disease. When lifestyle changes are ineffective, lipid-lowering drugs must be introduced to prevent pancreatitis. Fibrates greatly reduce triglyceride levels in patients with severe hypertriglyceridemia, and statins reduce LDL cholesterol levels and cardiovascular risk in patients with moderate hypertriglyceridemia. However there is an unmet need for the use of a more aggressive treatment with fewer side effects.
ISIS have developed a new drug, ISIS 304801, that has been designed to reduce the amount of apoC-III protein in the blood which is a key regulator of triglyceride levels.
This study is being done to see what effects ISIS 304801 has on fasting triglyceride levels in patients with hypertriglyceridemia, compared to placebo (an inactive drug sometimes known as a sugar pill).
Approximately 75 participants (men and women) aged 18 years and over with high levels of fasting triglycerides will take part in the study at approximately 11 sites worldwide. This is a multi-centre, double-blind, placebo-controlled study with participants receiving either 300 mg ISIS 304801 or placebo once a week for 26 weeks. Neither the participant or the study doctor will be aware of which treatment is received.REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0003
Date of REC Opinion
23 Feb 2015
REC opinion
Further Information Favourable Opinion