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Study on the Effects of Obicetrapib and Ezetimibe on Coronary Plaque in Patients with Atherosclerotic Cardiovascular Disease

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for people with Atherosclerotic Cardiovascular Disease. This condition involves the buildup of fatty deposits, known as plaques, in the arteries, which can lead to heart problems. The treatment being tested is a combination of two medications: Obicetrapib and Ezetimibe, both taken as a single tablet. The study will compare the effects of this combination treatment to a placebo.

The purpose of the study is to evaluate how the combination of Obicetrapib and Ezetimibe affects the volume of non-calcified plaques in the coronary arteries over a period of 18 months. Participants will undergo a special type of imaging called Coronary CT Angiography to measure changes in their coronary plaque characteristics. This imaging method provides detailed pictures of the heart's blood vessels, helping researchers understand how the treatment impacts plaque buildup.

Participants in the study will be randomly assigned to receive either the combination treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure that the results are unbiased. The study will last for 18 months, during which participants will have regular check-ups and imaging tests to monitor their heart health and the effects of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the study medication or a placebo. The study medication consists of a fixed dose combination of obicetrapib 10 mg and ezetimibe 10 mg.
The medication is administered in the form of a tablet and is taken orally once daily.
Step 2
Initial assessment
Participants will undergo an initial assessment to establish baseline measurements. This includes a coronary CT angiography (CCTA) to evaluate coronary plaque characteristics.
Blood tests will be conducted to measure levels of low-density lipoprotein cholesterol (LDL-C) and other relevant biomarkers.
Step 3
Medication administration
Participants will take the assigned medication daily for a period of 18 months.
Regular follow-up visits will be scheduled to monitor health status and ensure adherence to the medication regimen.
Step 4
Interim evaluations
At 3 months (Day 84), an interim evaluation will be conducted to assess changes in cholesterol levels and other biomarkers.
Additional blood tests and health assessments may be performed as needed.
Step 5
Final assessment
At the end of the 18-month period, a final assessment will be conducted. This includes a repeat CCTA to measure changes in coronary plaque volume.
Final blood tests will be performed to evaluate changes in LDL-C and other health indicators.
Step 6
Completion of study
Upon completion of the study, participants will receive a summary of their health assessments and any relevant findings.
Participants will be advised on any necessary follow-up care or lifestyle modifications based on the study results.

Who can join the trial?

10 criteria

Must be willing and able to give written consent and follow all study procedures.
Body mass index (BMI) should be between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
Must be 45 years or older. Both men and women can participate.
Women must not be pregnant or breastfeeding and should not plan to become pregnant during the study. They must use effective birth control methods.
Must have evidence of **Atherosclerotic Cardiovascular Disease (ASCVD)**, which is a condition affecting the heart and blood vessels. This can be shown by certain medical tests or a history of heart-related issues.
Must have a specific type of plaque in the heart arteries, as shown by a special heart scan.
Should be on medication to lower cholesterol, such as statins, or other similar treatments. Statins are drugs that help lower cholesterol levels in the blood.
Must have a fasting **LDL-C** level of 70 mg/dL or higher. LDL-C is a type of cholesterol often referred to as "bad" cholesterol.
Fasting **triglycerides** should be less than 400 mg/dL. Triglycerides are a type of fat found in the blood.
Must have a certain level of kidney function, measured by a test called the **glomerular filtration rate (GFR)**, which should be 40 mL/min/1.73 m² or higher.

Who cannot join the trial?

8 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent heart attack or stroke.
Patients with severe liver or kidney disease.
Patients who are currently participating in another clinical trial.
Patients who have an allergy to the study medications.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or take the study medications as directed.

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Verified sites

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, Poland

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Investigated drugs

Obicetrapib
is a medication being studied for its potential to reduce cholesterol levels. It works by inhibiting a protein that affects cholesterol metabolism, which may help in lowering the amount of bad cholesterol in the blood. In this trial, it is being tested to see if it can reduce the volume of plaque in the arteries of the heart.
Ezetimibe
is a medication that helps lower cholesterol levels by reducing the amount of cholesterol absorbed by the intestines. It is often used in combination with other cholesterol-lowering medications to enhance their effects. In this trial, it is combined with obicetrapib to evaluate their combined effect on reducing coronary plaque in patients with heart disease.

What is already known about the treatment

Obicetrapib
This medication is administered orally and is currently being studied in clinical trials for its effects on coronary plaque in patients with atherosclerotic cardiovascular disease. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication is to reduce non-calcified coronary atherosclerotic plaque volume. Obicetrapib works by inhibiting a protein involved in cholesterol transport, which may help lower cholesterol levels and reduce plaque buildup. It is classified as a cholesterol ester transfer protein (CETP) inhibitor.
Ezetimibe
This medication is also taken orally and is being evaluated in combination with obicetrapib in clinical trials for its potential benefits in atherosclerotic cardiovascular disease. Ezetimibe is already approved and used in medicine to lower cholesterol levels. It works by reducing the absorption of cholesterol in the small intestine, which helps decrease the amount of cholesterol in the bloodstream. Ezetimibe is classified as a cholesterol absorption inhibitor.

Investigated diseases

Atherosclerotic Cardiovascular Disease – This disease involves the buildup of fatty deposits, known as plaques, within the walls of arteries. Over time, these plaques can harden and narrow the arteries, reducing blood flow to vital organs. The progression of the disease can lead to complications such as chest pain or discomfort, especially during physical activity. As the condition advances, it may result in more severe issues like heart attacks or strokes due to the restricted blood supply. The disease often develops slowly over many years and can be influenced by factors such as diet, lifestyle, and genetics. Regular monitoring and lifestyle changes can help manage its progression.