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Study of laroprovstat (AZD0780) tablets to lower cholesterol levels in adults with inherited high cholesterol condition (heterozygous familial hypercholesterolemia)

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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 people with Heterozygous Familial Hypercholesterolemia, an inherited condition that causes high levels of LDL cholesterol (often called "bad" cholesterol) in the blood. The research evaluates a new medication called AZD0780 (laroprovstat), which is given as a film-coated tablet that patients take by mouth.

The purpose of this study is to determine how well AZD0780 works compared to placebo in lowering LDL cholesterol levels in patients who already take other cholesterol-lowering medications. The study will last for 52 weeks, during which participants will receive either AZD0780 or placebo in addition to their usual cholesterol-lowering treatments.

Throughout the study, researchers will monitor changes in various types of cholesterol and related substances in the blood, including apolipoprotein B, non-HDL cholesterol, total cholesterol, and lipoprotein(a). The main focus will be on measuring how much the LDL cholesterol levels change after 12 weeks of treatment.

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 treatment period

    You will receive either AZD0780 tablets or a placebo (a tablet that looks the same but contains no active medicine). Neither you nor your doctor will know which treatment you are receiving.

    You will need to continue taking your current cholesterol-lowering medications throughout the study.

    The treatment will be taken orally (by mouth) according to the prescribed schedule.

  2. Step 2

    12-week assessment

    After 12 weeks of treatment, your cholesterol levels will be measured to evaluate how well the medication is working.

    The main focus will be on measuring your LDL-C (low-density lipoprotein cholesterol, often called 'bad' cholesterol).

    Blood samples will be taken to measure various types of cholesterol and related substances in your blood.

  3. Step 3

    28-week follow-up

    Your cholesterol levels will be checked again after 28 weeks of treatment.

    This assessment will help determine the longer-term effects of the medication.

  4. Step 4

    52-week completion

    The final assessment will occur after 52 weeks (one year) of treatment.

    Your cholesterol levels will be measured one last time to evaluate the long-term effectiveness of the treatment.

    Various measurements will be taken, including LDL-C, Apo B (a protein in lipoproteins), and other cholesterol-related substances.

Who can join the trial?

11 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have Heterozygous Familial Hypercholesterolemia (HeFH) confirmed either through:
    • Genetic testing, or
    • Clinical diagnosis using recognized diagnostic criteria
    • Must have specific fasting blood cholesterol levels:
      • If you have heart disease: LDL cholesterol level of at least 55 mg/dL
      • If you don't have heart disease: LDL cholesterol level of at least 70 mg/dL
      • Must be on stable cholesterol-lowering medications:
        • Taking the highest tolerated dose of statin medication (drugs that lower cholesterol)
        • Using these medications for at least 28 days before screening
        • Preferably also taking a medication called ezetimibe
        • If unable to take high-dose statins, you may still qualify if:
          • You can tolerate lower doses of statins, or
          • You have documented side effects from at least 2 different statins, or
          • You take other medications that prevent you from using statins

Who cannot join the trial?

14 criteria

  • Age below 18 years old or above 65 years old
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Current participation in other clinical trials
  • Uncontrolled high blood pressure (blood pressure consistently above 140/90 mmHg)
  • History of heart attack or stroke within the past 6 months
  • Severe liver disease (indicated by liver function tests more than 3 times the normal range)
  • Severe kidney disease (indicated by estimated glomerular filtration rate below 30 mL/min)
  • Active cancer or ongoing cancer treatment
  • Unable to provide informed consent
  • History of substance abuse within the past year
  • Taking medications that may interact with the study drug
  • Mental health conditions that could interfere with study participation
  • History of non-compliance with medical treatments
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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 with an inherited condition that causes high cholesterol levels. The medication is being tested to see if it can help patients with a genetic condition called heterozygous familial hypercholesterolemia, which causes abnormally high cholesterol levels that can be difficult to treat with standard medications.

What is already known about the treatment

AZD0780 - An investigational medication being studied in Phase III clinical trials for the treatment of heterozygous familial hypercholesterolaemia, a genetic condition characterized by high cholesterol levels. The drug is being evaluated for its ability to reduce low-density lipoprotein cholesterol (LDL-C) levels over a 12-week treatment period. While the exact mechanism of action is still under investigation through clinical trials, this compound belongs to the class of cholesterol-lowering medications, with administration details and dosage forms being tested in the current research protocol. The medication is being studied in a double-blind, placebo-controlled setting to establish its efficacy and safety profile for potential future use in managing familial hypercholesterolaemia.

Investigated diseases

Heterozygous Familial Hypercholesterolemia – A genetic condition that causes high levels of LDL (bad) cholesterol from birth. People with this condition inherit one defective gene from one parent, affecting their body's ability to remove cholesterol from the blood. It leads to consistently elevated cholesterol levels throughout life, particularly affecting LDL cholesterol. The condition results in the build-up of fatty deposits in blood vessels over time. The disorder affects the body's ability to process cholesterol normally due to problems with specific proteins called LDL receptors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520520-17-00Protocol codeD7960C00013Estimated enrolment473 patientsSponsorAstraZeneca AB

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