MEDICI
Research type
Research Study
Full title
A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk
IRAS ID
1013543
Contact name
Paolo Fabrizzi
Contact email
Sponsor organisation
A. Menarini International Licensing S.A (AMIL)
Clinicaltrials.gov Identifier
Research summary
This is a study of a new medicine called Obicetrapib (OBI) in participants with "dyslipidaemia", a condition where there are harmful levels of fats in the blood. People with this condition have abnormally high levels of fats (lipids), such as Low-Density Lipoprotein Cholesterol (LDL-C, also called “bad cholesterol”) measured in the bloodstream. When LDL-C is too high, it can build up in the walls of blood vessels which disrupt the normal smooth lining. Over time this harmful build-up of fats and other substances in the arteries can lead to serious cardiovascular events (CV events), such as heart attack, stroke, or poor blood supply to the legs.
The level of LDL-C in the blood can (in combination with other factors) predict if a person is at high or very high risk of having CV events in the future. Lowering LDL-C has been shown to reduce this risk. Lipid-lowering medicines, such as statins, are the standard therapy for dyslipidaemia, but do not always work well enough to lower the levels of LDL-C to recommended targets.
OBI is a new medicine which blocks a protein in human body, called ‘cholesteryl ester transfer protein’ (CETP), which lowers "good" cholesterol (High-Density Lipoprotein Cholesterol, HDL-C) and raises "bad" cholesterol (LDL-C). So, by blocking CETP with OBI, it is expected that the amount of LDL-C in the blood will go down.
Bempedoic Acid (BPA) is a medicine already available, which reduces LDL-C with a different mechanism of action.
In this study, researchers want to compare the effectiveness and safety of the new medicine Obicetrapib with Bempedoic Acid (BPA) in patients with dyslipidaemia who are already taking statins, but are still not able to achieve their recommended LDL-C target levels.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
26/ES/0011
Date of REC Opinion
24 Mar 2026
REC opinion
Further Information Favourable Opinion