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Effect of laroprovstat/rosuvastatin combination versus laroprovstat, rosuvastatin, and placebo on LDL‑C in hypercholesterolemia patients not previously treated with lipid‑lowering therapy

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What is this trial about?

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

The study looks at adults who have not yet taken medicines to lower their blood fats and who have hypercholesterolaemia. The medicines being tested are a pill that contains both laroprovstat and rosuvastatin together, and each of those drugs given alone. Some participants will receive a placebo, which looks the same but does not contain active medicine. The purpose of the study is to see how well the combination pill lowers the amount of “bad” cholesterol, known as LDL‑C, compared with the single drugs and with the placebo.

The study will last about eight weeks. Participants will take the assigned tablet once each day, and blood samples will be taken at the start and at the end to measure changes in LDL‑C, as well as other blood‑fat measurements such as Apo B and non‑HDL‑C. The information gathered will help determine whether the combined pill works better than the individual medicines.

The research process

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

  1. Step 1

    Randomization to a treatment group

    After you agree to take part, you are assigned by a computer to one of the study groups. the possible groups are a fixed‑dose combination of laroprovstat and rosuvastatin (group 1 or group 2), rosuvastatin alone, laroprovstat alone, or a placebo that contains no active medicine.

  2. Step 2

    Baseline health assessment

    Before you start taking any tablet, a short visit is scheduled. during this visit blood is drawn to measure your low‑density lipoprotein cholesterol (ldl‑c), apolipoprotein B (apo b), non‑high‑density lipoprotein cholesterol (non‑hdl‑c) and total cholesterol. basic health checks are also performed to confirm that you meet the study requirements.

  3. Step 3

    Starting the study medication

    You receive a supply of tablets that must be taken by mouth once each day. the tablet may contain rosuvastatin, laroprovstat, both medicines together, or no active ingredient (placebo), depending on the group you were assigned to.

    The exact amount of each active ingredient is a fixed dose defined by the study protocol (the label shows the dose in milligrams, but the specific number is not disclosed to participants).

    Take the tablet at the same time each day, with or without food, and do not split or chew it.

  4. Step 4

    Daily dosing period

    Continue to take one tablet every day for a total of eight weeks. no other cholesterol‑lowering medicines should be started during this period unless instructed by the study doctor.

  5. Step 5

    Final visit at eight weeks

    After eight weeks of daily dosing you return for a final visit. another blood sample is taken to measure changes in ldl‑c, apo b, non‑hdl‑c and total cholesterol.

    The study staff will record any side effects you experienced and may perform a brief physical check.

  6. Step 6

    Study completion

    Once the final assessments are finished, you stop taking the study tablets. you may be given information about the overall study results after the trial ends.

Who can join the trial?

3 criteria

  • Be at least 18 years old.
  • Have no past history of atherosclerotic cardiovascular disease (ASCVD) (this means no previous heart attacks, strokes, or blockages in the arteries) and have a low 10‑year ASCVD risk (the chance of having a heart‑related event in the next ten years is low).
  • Not have taken any lipid‑lowering therapy (LLT) (medicines that lower cholesterol) during the three months before the screening visit.

Who cannot join the trial?

5 criteria

  • People of Asian origin.
  • People who cannot tolerate statins (medicines that lower cholesterol) because they cause side effects such as muscle pain.
  • People with very high blood pressure (severe hypertension) that is not under control with medication.
  • People with type 2 diabetes (type 2 diabetes mellitus) whose blood sugar is not well controlled.
  • People with an underactive thyroid (hypothyroidism) that is not being treated properly.
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Investigated drugs

  • Rosuvastatin (Crestor)

    is a cholesterol‑lowering pill taken by mouth. In this study it is used by itself to see how well it reduces “bad” cholesterol (LDL‑C) compared with the other treatments. Rosuvastatin works by blocking a substance in the liver that makes cholesterol, helping to lower the amount of cholesterol that circulates in the blood.

  • Laroprovstat (AZD0780)

    is an oral medication that also aims to lower LDL‑C. It belongs to a class of drugs that target a different step in cholesterol production than rosuvastatin. In the trial, participants receive laroprovstat alone so researchers can compare its effect on cholesterol with that of rosuvastatin and with the combination pill.

  • Laroprovstat/Rosuvastatin Fixed‑Dose Combination (FDC)

    is a single tablet that contains both laroprovstat and rosuvastatin together. By combining the two medicines, the study tests whether using them at the same time provides a greater reduction in LDL‑C than either drug alone. Patients take this combination pill orally, and the trial compares two different strengths of the FDC against the individual drugs and placebo.

What is already known about the treatment

  • Rosuvastatin (Crestor)

    An oral hard capsule taken by mouth that is already approved and widely used to treat high cholesterol, especially to lower “bad” LDL cholesterol. It belongs to the statin class and works by blocking the enzyme HMG‑CoA reductase, which reduces the body’s production of cholesterol. Rosuvastatin is listed in medical guidelines for hypercholesterolaemia and has a long record of safety and effectiveness in the literature.

  • Laroprovstat (AZD0780)

    An oral film‑coated tablet that is still under investigation in clinical trials and not yet approved for routine medical use. It is being studied as a new lipid‑lowering agent that blocks the PCSK9 protein, helping the body keep more LDL receptors on liver cells to clear cholesterol from the blood. The drug is classified as a PCSK9 inhibitor (small‑molecule type) and is intended for patients with high cholesterol. Current scientific reports describe it as a promising but experimental therapy.

  • Laroprovstat/Rosuvastatin Fixed‑Dose Combination

    An oral film‑coated tablet that combines rosuvastatin and laroprovstat in one pill, used in the trial to see if the two drugs work better together. It is an investigational product that pairs a statin (which blocks cholesterol production) with a PCSK9 inhibitor (which increases removal of LDL cholesterol). The combination is aimed at treating hypercholesterolaemia and is classified as a fixed‑dose combination of a statin and a PCSK9 inhibitor. It is not yet approved and is currently being evaluated in clinical research.

Investigated diseases

Hypercholesterolemia - Hypercholesterolemia is a condition where blood cholesterol levels are higher than normal. It often develops gradually as diet, genetics, and lifestyle contribute to excess cholesterol. Over time, the excess can accumulate in the walls of arteries, leading to thickening of the arterial wall. This thickening can narrow the vessels and reduce blood flow. The condition may persist and worsen if cholesterol intake remains high or other risk factors are present.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525642-30-00Protocol codeD7961C00002Estimated enrolment455 patientsSponsorAstraZeneca AB

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