PREVAIL
Research type
Research Study
Full title
Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies.
IRAS ID
1004686
Contact name
Marc Ditmarsch
Contact email
Sponsor organisation
NewAmsterdam Pharma BV
Eudract number
2021-005092-39
Clinicaltrials.gov Identifier
Research summary
Despite advances in treatment, cardiovascular (CV) disease (CVD) is the leading cause of death globally, resulting in over 17 million deaths every year. Low-density lipoprotein cholesterol (LDL-C) has been identified as one of the major modifiable risk factors for the development of CVD and a strong relationship between lowering LDL-C levels and a reduction in the risk of heart attack and death has been demonstrated. Patients with Atherosclerotic CVD (ASCVD) are at a very high risk for cardiovascular (CV) events and require drug intervention. Lipid-lowering therapies, predominantly statins, are now widely used to reduce LDL-C and the risk of CV events in patients. However, even with the availability of these therapies, there remains an unmet need in some ASCVD patients who are unable to achieve or maintain their LDL-C treatment goals despite the addition of lipid-lowering agents to maximally-tolerated statin therapy.
This is a placebo-controlled, double blind, randomised Phase 3 study designed to evaluate the effect of 10 mg Obicetrapib in participants with a history of ASCVD who are not well-enough controlled despite receiving maximally-tolerated lipid-lowering therapies. Approximately 9000 eligible ASCVD patients will take part at 460 research centres in the United States, Canada, Europe, Asia and Australia.
Patients will be randomised in a 1:1 ratio to:
- Obicetrapib group (4500 patients): One 10mg Obicetrapib tablet once-daily; or
- Placebo group (4500 patients): One placebo tablet once-daily.The study will consist of a Screening Period, a 30-month or greater Treatment Period and a 35 to 60-day post-treatment Follow-Up Period. As this is an event driven study, the actual study duration may vary, but the median study duration for each participant is expected to be at least 32 months.
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0187
Date of REC Opinion
6 Apr 2022
REC opinion
Further Information Favourable Opinion