Atherosclerotic Cardiovascular Disease (ASCVD) Study

What is the purpose of the PREVAIL study?

The PREVAIL trial is being conducted to determine whether an investigational new drug, previously shown to reduce circulating levels of bad cholesterol (low-density lipoprotein cholesterol), can also reduce the risk of serious cardiovascular events (like a heart attack or stroke) in individuals who have cardiovascular disease.

The most common cause of cardiovascular disease is the accumulation of fatty build-up in the blood vessels also known as atherosclerotic cardiovascular disease (ASCVD). If this happens in the heart blood vessels this is known as coronary artery disease (CAD). If this happens in the blood vessels supplying blood to the legs this is known as peripheral arterial disease (PAD) or leg claudication, and/or vessels supplying blood to the brain this is known as cerebrovascular disease.

Ultimately this disease process can result in serious cardiovascular events including angina (pain in the chest), heart attack, stroke, leg claudication (pain in the leg) and ultimately severe debilitation or even death.

What is the study drug?

The study drug, obicetrapib 10 mg, is a small tablet taken by mouth once a day. It is designed to reduce bad cholesterol levels, also known as low-density lipoprotein cholesterol (LDL-C), which is a harmful form of cholesterol. LDL-C causes fatty build-up in the arteries, which narrows the arteries and increases the risk of cardiovascular disease.

Obicetrapib is an investigational drug, which means it can only be used for research studies. It has not been approved by regulatory authorities like the Food and Drug Administration (FDA) or European Medicines Agency (EMA).

What will happen during the study?

Before receiving any study drug or study related assessments, your eligibility for participation and consent to participate are required. You will need to satisfy specific inclusion and exclusion criteria to enroll into the study.

Once you consent to participate in the trial during the Screening Visit, you will then attend 4 further visits (Months 0, 3, 6, 12) during the first year, followed by visits every 6 months for the remainder of the study. Between visits at the study center, you will have telephone visits to see how you are feeling.

As this is an event-driven study (meaning that the study will last until a certain number of cardiovascular events happen in the study participants), the actual study duration may vary. We anticipate that participants can expect to be in the study for about 3-4 years.

Participation includes:

- Study clinic visits with physical exams, blood tests, and the assessment of possible experienced cardiovascular events
- Assigned at random (like a coin flip) to receive either the study drug obicetrapib or placebo (which contains no active ingredients), with 50% (1 in 2) chance of receiving study drug

  • Assigned study drug (or placebo) to be taken by mouth once a day with water at around the same time each day
  • Neither you or your investigating physician will know which tablet (study drug or placebo) you are taking

- Follow-up telephone visit after the last dose of the assigned study drug or placebo
- Continue taking pre-existing medication to lower cholesterol that has been regularly prescribed by your general practitioner/family physician (if applicable)

What is Atherosclerotic Cardiovascular Disease (ASCVD)?

Atherosclerotic cardiovascular disease (ASCVD) is an umbrella term for the clinical manifestations of fatty plaque buildup within the walls of arteries. It refers to diseases including coronary heart disease, cerebrovascular diseases, peripheral artery disease and more. Plaque buildup causes narrowed or blocked blood vessels, which restricts or completely obstructs blood flow, leading to serious cardiovascular events like a heart attack or stroke.

Despite advances in treatment, cardiovascular disease (CVD) is still the leading cause of death globally, resulting in over 17 million deaths annually. Elevated levels of bad cholesterol also known as low-density lipoprotein cholesterol (LDL-C) is a very important risk factor for the development of CVD.

Patients with documented ASCVD are at very high risk to experience future serious cardiovascular events, and many patients with ASCVD are unable to reduce their high levels of LDL-C cholesterol sufficiently to reach a desired (target) level. The study drug obicetrapib may offer a potentially effective option for these people to reach this desired LDL-C level.