Phase III study of Inclisiran Sodium in participants with ASCVD
Research type
Research Study
Full title
A randomized, double-blind, placebo controlled trial to evaluate the effect of 300mg of inclisiran sodium given as subcutaneous injections in subjects with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)
IRAS ID
231193
Contact name
Manish Saxena
Contact email
Sponsor organisation
The Medicines Company
Eudract number
2017-001846-90
Duration of Study in the UK
2 years, 3 months, 14 days
Research summary
This is a multicentre study of 300mg Inclisiran Sodium given as subcutaneous injections in participants with Atherosclerotic Cardiovascular Disease (ASCVD) or is at risk of getting ASCVD as well as having elevated low-density lipoprotein cholesterol (LDL-C) also called ‘bad’ cholesterol. The study is funded by The Medicines Company.
The standard current treatment for lowering ‘bad’ cholesterol is medication such as statins. However, this treatment alone is sometimes not enough in some patients and the ‘bad’ cholesterol remains too high. Also, some patients are not able to tolerate statins in standard doses. For this reason there is a need to develop new therapies with the potential to help manage this ‘bad’ cholesterol more effectively. The study sponsor, The Medicines Company are developing an investigational drug called Inclisiran which has been tested previously in approximately 500 people and the results showed that Inclisiran has the potential to reduce the ‘bad’ cholesterol levels in the blood. Inclisiran belongs to a class of drugs called PCSK-9 inhibitors.
This current study is a multi-centre, multi-national study using 300mg Inclisiran Sodium given as subcutaneous injections in participants with Atherosclerotic Cardiovascular Disease (ASCVD - coronary artery disease, ischaemic strokes and peripheral vascular disease) or at risk of getting ASCVD as well as having elevated low- density lipoprotein cholesterol (LDL-C) also called ‘bad’ cholesterol. The study is funded by The Medicines Company. Approximately 1500 participants will be recruited globally with around 420 participants recruited in the UK. Treatment will last for up to 18 months and total duration for individual participants is expected to be 554 days (18 months).
Eligible participants will be randomly assigned to receive either Inclisiran or matching placebo (pill with no medicine) in a 1:1 ratio. Participants will make a total of 10 visits and receive an injection of Inclisiran or matching placebo at 4 of the 10 visits.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1582
Date of REC Opinion
19 Oct 2017
REC opinion
Further Information Favourable Opinion