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Study on the Effect of Obicetrapib in Patients with Atherosclerotic Cardiovascular Disease Not Adequately Managed by Current Lipid-Lowering Treatments

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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 medication called Obicetrapib in people with atherosclerotic cardiovascular disease (ASCVD). ASCVD is a condition where the arteries become narrowed due to the buildup of plaque, which can lead to serious heart and blood vessel problems. The study aims to see how well Obicetrapib works in reducing the risk of major heart-related events, such as heart attacks, strokes, or the need for certain heart procedures, in participants whose current treatments are not fully effective.

Participants in the study will receive either Obicetrapib or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The study will last for a period of time, during which participants will take the medication or placebo and attend regular check-ups to monitor their health and any changes in their condition.

The goal of the study is to gather information on how Obicetrapib affects the risk of serious cardiovascular events in people with ASCVD. By participating, researchers hope to better understand the potential benefits of this medication for those who are not adequately helped by their current treatments. The study will provide valuable insights into the effectiveness of Obicetrapib in managing heart and blood vessel health in individuals with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is randomly assigned to receive either the active medication, obicetrapib, or a placebo. The study is double-blind, meaning neither the participant nor the researchers know which treatment the participant is receiving.

  2. Step 2

    Medication administration

    Participants take a 10 mg dose of obicetrapib or a matching placebo orally once daily. The medication is in the form of a capsule.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, participants are monitored for any major cardiovascular events, such as heart-related death, non-fatal heart attack, non-fatal stroke, or the need for urgent heart procedures.

    Regular follow-up visits are scheduled to assess the participant's health and the effectiveness of the treatment.

  4. Step 4

    Study duration

    The study is expected to continue until December 31, 2025. Participants remain in the study for the entire duration unless they experience significant health changes or choose to withdraw.

  5. Step 5

    End of study

    At the end of the study, participants undergo a final evaluation to determine the overall impact of the treatment on their cardiovascular health.

Who can join the trial?

14 criteria

  • Must be a male or female who is **18 years or older** at the time of the first screening visit.
  • Must have a history of **ASCVD** (atherosclerotic cardiovascular disease), which includes conditions like coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
  • Must be on the highest dose of **lipid-modifying therapy** they can tolerate, along with a diet and lifestyle changes to lower cholesterol. This includes:
    • Taking a **statin** at the highest dose they can handle.
    • Taking **ezetimibe** for at least 8 weeks, with or without a statin, before the first screening visit.
    • Taking **bempedoic acid** for 4-8 weeks with a statin before the first screening visit.
    • Using a **PCSK9-targeted therapy** alone or with other cholesterol-lowering treatments for at least 4 stable doses before the first screening visit.
    • At least 70% of participants must be taking **high-intensity statins (HISs)**, such as atorvastatin 40 and 80 mg or rosuvastatin 20 and 40 mg. If unable to take HISs, the reason must be documented.
    • Must have a **fasting serum LDL-C** (a type of cholesterol) level at the first screening visit that meets one of the following:
      • Between 55 mg/dL and less than 100 mg/dL, with at least one of these risk factors:
        • Recent heart attack (more than 3 months but less than 12 months before randomization).
        • Type 2 diabetes.
        • Fasting triglycerides (another type of fat in the blood) greater than 150 mg/dL.
        • Fasting high-density lipoprotein cholesterol (good cholesterol) less than 40 mg/dL.
        • Or, have a fasting serum LDL-C of 100 mg/dL or higher.
        • Must have **fasting triglycerides** less than 400 mg/dL at the first screening visit.
        • Must have an **estimated glomerular filtration rate** (a measure of kidney function) of 30 mL/min/1.73 m² or higher, calculated using a specific equation, at the first screening visit.

Who cannot join the trial?

4 criteria

  • Patients with certain heart and blood vessel diseases, specifically those caused by the narrowing of arteries due to a buildup of plaque, cannot participate.
  • Patients who are not within the specified age range for the study are excluded.
  • Patients who belong to certain clinical trial groups that are not eligible for this study cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might be at higher risk or need special protection, are excluded.
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Investigated drugs

Obicetrapib is a medication being studied for its potential to reduce the risk of major cardiovascular events in people with atherosclerotic cardiovascular disease. This condition involves the buildup of fats, cholesterol, and other substances in and on the artery walls, which can restrict blood flow. Obicetrapib is being tested to see if it can help lower the chances of serious heart-related problems, such as heart attacks, strokes, or the need for procedures to improve blood flow in the heart.

What is already known about the treatment

Obicetrapib – Obicetrapib is administered orally in tablet form. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness in reducing cardiovascular events in patients with atherosclerotic cardiovascular disease who are not adequately managed with existing lipid-modifying therapies. The main therapeutic indication for obicetrapib is to lower the risk of major adverse cardiovascular events, such as heart attacks and strokes. At the molecular level, obicetrapib works by inhibiting a protein involved in cholesterol transport, which helps to reduce cholesterol levels in the blood. It is classified as a cholesterol ester transfer protein (CETP) inhibitor.

Investigated diseases

Atherosclerotic Cardiovascular Disease – This disease involves the narrowing of arteries due to the buildup of plaque, which is a combination of fat, cholesterol, and other substances. As the plaque accumulates, it can harden and restrict blood flow, potentially leading to serious complications. Over time, the reduced blood flow can cause symptoms such as chest pain or discomfort, especially during physical activity. If a plaque ruptures, it can form a blood clot, which may further block the artery or travel to other parts of the body. This can result in major adverse cardiovascular events like heart attacks or strokes. The progression of the disease can vary, with some individuals experiencing rapid changes while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507795-51-00Protocol codeTA-8995-304Estimated enrolment9 066 patientsSponsorNewAmsterdam Pharma B.V.

sourced from the EU Clinical Trials Register and site verification

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