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Study of AZD0780 in patients with high cholesterol and heart disease or risk of heart disease to lower bad cholesterol levels

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What is this trial about?

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

This study focuses on patients with hyperlipidemia (high levels of blood fats) and atherosclerotic cardiovascular disease, a condition where arteries become hardened and narrowed. The study will test a new medication called AZD0780 (laroprovstat) in people who have high levels of "bad" cholesterol (also known as LDL cholesterol) despite taking their usual cholesterol-lowering medicines.

The purpose of this research is to determine how well AZD0780 works compared to placebo in lowering LDL cholesterol levels after 12 weeks of treatment. The medication comes as a film-coated tablet that is taken by mouth. Some participants will receive AZD0780, while others will receive a placebo.

The study will last for 52 weeks (one year), during which participants will continue taking their regular cholesterol-lowering medications. Throughout the study, researchers will measure various types of cholesterol and other blood fats, including apolipoprotein B, non-HDL cholesterol, and lipoprotein(a), to understand how well the treatment works.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and medication start

    Your blood cholesterol levels will be measured after fasting

    You will receive AZD0780 tablets or placebo (inactive substance) tablets for oral use

    You will continue your current cholesterol-lowering medications, including statins if you are taking them

  2. Step 2

    12-week assessment

    Your blood cholesterol levels will be measured again after 12 weeks of treatment

    The main focus will be on measuring your LDL-C (bad cholesterol) levels

    Additional blood tests will check other types of fats in your blood, including: Apo B, non-HDL-C, total cholesterol, and Lp(a)

  3. Step 3

    28-week assessment

    Your blood cholesterol levels will be checked again at 28 weeks

    The focus remains on measuring changes in your LDL-C levels

  4. Step 4

    52-week assessment

    A final measurement of your blood cholesterol levels will be taken at 52 weeks

    This completes one year of participation in the study

    The main focus will be on measuring the long-term changes in your LDL-C levels

Who can join the trial?

14 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have either:
    • A history of heart and blood vessel disease (like heart attack, chest pain, stroke, or artery problems), or
    • Be at risk for heart disease due to conditions like:
      • Narrowed arteries in multiple areas
      • Diabetes
      • High blood pressure
      • Smoking
      • Kidney disease
      • Obesity
      • Must have specific levels of cholesterol (LDL-C) in blood tests:
        • At least 55 mg/dL if you have existing heart disease
        • At least 70 mg/dL if you are at risk but don't have heart disease yet
        • Must be taking the highest tolerated dose of cholesterol-lowering medications (statins) with:
          • A stable dose for more than 28 days
          • If unable to take high-dose statins, must be on lower doses
          • If not taking any statins, must have documented side effects from trying at least 2 different statins
          • Both men and women can participate

Who cannot join the trial?

14 criteria

  • History of serious allergic reactions or severe sensitivity to any medications
  • Currently pregnant or breastfeeding women
  • Severe liver problems (as indicated by liver function tests more than 3 times the normal upper limit)
  • Uncontrolled high blood pressure (blood pressure readings consistently above 160/100 mmHg)
  • Recent heart attack or stroke (within the last 6 months)
  • Active cancer or ongoing cancer treatment
  • Participation in another clinical trial within the past 30 days
  • Severe kidney disease (with creatinine clearance less than 30 mL/min - a measure of kidney function)
  • History of muscle problems related to cholesterol-lowering medications
  • Uncontrolled diabetes (blood sugar levels consistently above normal range)
  • Taking medications that could interact with the study drug
  • History of substance abuse within the past year
  • Mental health conditions that could affect ability to comply with study procedures
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

AZD0780 is an investigational medication being studied for its effects on lowering LDL cholesterol (often called "bad" cholesterol) in patients who have high cholesterol levels. This medication is being tested in people who either have existing cardiovascular disease or are at risk of developing cardiovascular problems. The medication is designed to help reduce cholesterol levels in the blood, which may help prevent heart disease and related complications.

What is already known about the treatment

AZD0780 - An investigational medication being studied in Phase III clinical trials for the treatment of high cholesterol (hyperlipidemia) and atherosclerotic cardiovascular disease. The drug is being evaluated for its ability to reduce low-density lipoprotein cholesterol (LDL-C) levels in patients with elevated cholesterol who either have existing cardiovascular disease or are at risk for their first cardiovascular event. While the specific mechanism of action and administration route are not publicly disclosed in the trial data, this experimental drug represents a new potential therapeutic option in the field of cardiovascular medicine, with its effectiveness being compared to placebo in a randomized, double-blind study over a 12-week period.

Investigated diseases

  • Hyperlipidemia

    A condition characterized by elevated levels of lipids (fats) in the blood, particularly cholesterol and triglycerides. The condition develops gradually over time and can be influenced by both genetic factors and lifestyle choices. It often occurs without noticeable symptoms but leads to fatty deposits in blood vessels. The condition affects how the body processes and stores fats from food.

  • Atherosclerotic cardiovascular disease

    A condition where plaque builds up inside the arteries, causing them to narrow and harden over time. The plaque consists of fat, cholesterol, calcium, and other substances found in the blood. As arteries become narrower, blood flow to various parts of the body becomes restricted. The process develops gradually over many years and can affect arteries throughout the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520521-21-00Protocol codeD7960C00012Estimated enrolment3 104 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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