ISIS 494372-CS3
Research type
Research Study
Full title
A Randomized, Double Blind, Placebo-Controlled, Dose Titration, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 494372 Administered Subcutaneously to Patients with High Lipoprotein(a)
IRAS ID
157943
Contact name
Handrean Soran
Contact email
Sponsor organisation
Isis Pharmaceuticals, Inc.
Eudract number
2014-000701-13
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
High Lipoprotein(a) [(Lp(a)] may cause diseases such as heart disease and stroke. It is thought that a pharmacologic reduction in Lp(a) could slow down or reverse these cardiovascular events, however treatments that are aimed at reducing Lp(a) levels in humans, and particularly drugs that specifically target only Lp(a), are few. There are alternative treatments such as niacin or apheresis. The process of apheresis involves removal of blood from a patient, whole blood separation and then one of the separated portions of the blood is then re-transfused into the patient.
The Study Drug, ISIS 494372, belongs to a group of drugs called second-generation antisense oligonucleotides and is designed to reduce the production of apolipoprotein(a) [apo(a)] a protein produced in the liver that combines with a lipid (fat) to form the lipoprotein, Lp(a). . There are no reports linking very low Lp(a) to any deleterious effects.
Isis Pharmaceuticals is sponsoring a study to see if ISIS 494372 is safe and tolerable in patients with high Lp(a) and effective in lowering Lp(a) levels. The study will also to determine how long the drug stays in your blood. The Sponsor also wants to compare the effects of ISIS 494372 with placebo (an inactive substance that contains no medicine).
Patients with high Lp(a) with be assigned to
Cohort A- 50 Patients with Lp(a) 50 and <175 mg
Cohort B- 10 Patients with Lp(a) ≥175 mg
All patients will receive escalating doses of 100, 200, and 300 mg/week or placebo, by subcutaneous injection.
This is a multicentre study which will take place across Europe and in Canada. Approximately 70 patients (males and females) between the ages of 18 and 65 years that have high Lp(a) will be recruited in the study.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1053
Date of REC Opinion
11 Nov 2014
REC opinion
Further Information Favourable Opinion