Laroprovstat/rosuvastatin versus rosuvastatin for lowering LDL‑C in patients with high cholesterol

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What is this study about?

Hypercholesterolaemia is a condition in which the blood contains too much cholesterol, increasing the risk of heart disease. The study evaluates a new fixed‑dose combination tablet that contains laroprovstat/rosuvastatin and compares it with the standard medication rosuvastatin. Both products are taken by mouth as a single tablet.

The purpose of the study is to compare how well the two treatments lower LDL‑C after eight weeks. Participants are randomly assigned to receive the combination tablet, the standard medication, or a placebo, and they take the assigned pill once daily for about two months. During this time they attend a few clinic visits where blood samples are taken to check cholesterol levels.

In addition to LDL‑C, the study also measures changes in Apo B, non‑HDL‑C, and total cholesterol, which are other indicators of heart risk. Blood tests are done at the start and at the end of the eight‑week period to see how each measure changes. The study follows participants only for the short treatment period and does not involve any other procedures.

1 enrollment and consent

after joining the study you will sign a consent form that explains the purpose of the trial and what is expected of you.

2 baseline assessment

a visit is scheduled to collect basic health information, perform a physical exam, and draw blood for laboratory tests such as cholesterol levels.

3 randomization

based on a computer‑generated list you will be assigned to receive either the laroprovstat/rosuvastatin fixed‑dose combination tablet (test group) or a rosuvastatin capsule (comparator group). the study is double‑blind, so you will not know which medication you receive.

4 receiving study medication

you will be given a supply of the assigned medication. the tablet or capsule contains 00 mg of each active ingredient and is taken by mouth.

5 starting medication

take one tablet (if assigned to the combination) or one capsule (if assigned to rosuvastatin alone) each day, preferably at the same time each day, for a total of 8 weeks.

6 mid‑study follow‑up (week 4)

a clinic visit is scheduled around week 4 to check your health, review any side effects, and may include a short blood test to monitor safety.

7 final assessment (week 8)

at the end of week 8 you will return for a final visit. blood samples will be taken to measure ldl‑c (low‑density lipoprotein cholesterol), apo b (apolipoprotein B), non‑hdl‑c (non‑high‑density lipoprotein cholesterol), and total cholesterol. these results are used to evaluate the effect of the treatment.

8 study completion

after the final assessments you will stop taking the study medication. the study team will provide information about the overall study results and any follow‑up care that may be needed.

Who Can Join the Study?

Be at least 18 years old.
Have high cholesterol (hypercholesterolaemia).
Be taking a steady (unchanging) amount of all other cholesterol‑lowering medicines, called background lipid‑lowering therapies (LLTs).
Be using a statin medication at the highest dose that you can tolerate without unacceptable side effects; this is called the maximally tolerated dose.
Have either had a previous heart or blood‑vessel problem such as a heart attack, stroke, or similar event (a clinical ASCVD event) OR be considered at higher risk for having such an event for the first time.
Both men and women are allowed to join the study.

Who Cannot Join the Study?

People who are of Asian origin cannot take part in the study.
People with severe hypertension that is not under control (meaning very high blood pressure that has not been successfully treated) cannot take part.
People with type 2 diabetes mellitus (T2DM) that is not well controlled (meaning blood sugar levels are not kept in the target range) cannot take part.
People with an underactive thyroid (hypothyroidism) that is not being treated adequately cannot take part.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
Gemeinschaftspraxis Prof. Dr. med. Jeserich/Dr. med. Malleier	Nürnberg	Germany
Cgkwwmcluuisk Cuh Gwue	Frankfurt	Germany
Mbhprqm Cirael &yajuyt Ugyolomfhr Ob Fvbbczhm	Freiburg Im Breisgau	Germany
Kszkjvqlj Fxqwqdfdm Htechjicimklxr Gjma	Hanover	Germany
Knhitbfcfwfe Sivwucsg	Kaiserslautern	Germany
Cpv Sshzxyxmxgzbyup Hmuqkxy	Munich	Germany
Ukulzdbsebtrtpoxsbdiv Ljwoxcf Auu	Leipzig	Germany
Svrlhowcehmzih Bowogphvabufwvjd	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	15.09.2026

Trial locations

Investigated Drugs:

Rosuvastatin

Laroprovstat/Rosuvastatin FDC is a pill that contains two medicines together: laroprovstat, a newer drug that helps lower bad cholesterol, and rosuvastatin, a well‑known statin that also reduces cholesterol. In the study participants take this film‑coated tablet by mouth. The goal is to see if the combination works better at lowering LDL‑cholesterol than rosuvastatin alone.

Crestor (rosuvastatin) encapsulated tablet is a hard capsule that contains only rosuvastatin, a statin medication that lowers LDL‑cholesterol. It is taken by mouth and is used in the trial as the standard treatment to compare against the combination pill.

Hypercholesterolemia – Hypercholesterolemia is a condition in which the level of cholesterol in the blood is higher than normal. It often begins silently and may be detected only through blood tests. Over time, the excess cholesterol can accumulate in the walls of arteries, making them thicker and less flexible. This buildup can gradually narrow the arteries and reduce blood flow. The condition may persist or worsen if the underlying factors, such as diet or genetics, are not addressed.

Trial ID:

2026-526258-15-00

Protocol code:

D7961C00001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Laroprovstat/rosuvastatin versus rosuvastatin for lowering LDL‑C in patients with high cholesterol

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?