Not yet recruiting

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

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

4 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany
Verified
Studienzentrum Bocholderstrasse
Essen, Germany
Verified
Universitaetsklinikum Leipzig AöR
Leipzig, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

Rosuvastatin

What is already known about the treatment

Laroprovstat/Rosuvastatin FDC
This medication is taken by mouth as a film‑coated tablet that contains both rosuvastatin and laroprovstat. It is an approved drug combination that is being studied in clinical trials and is listed in medical literature as a lipid‑lowering therapy. It is used to treat high cholesterol, especially to lower “bad” LDL cholesterol. Rosuvastatin works by blocking an enzyme that makes cholesterol in the liver, while laroprovstat helps the liver clear LDL particles from the blood; together they belong to the class of statins combined with a cholesterol‑clearing agent.
Crestor (rosuvastatin) encapsulated tablet
This drug is taken orally in a hard capsule form that contains rosuvastatin alone. Rosuvastatin is a well‑known, widely prescribed medication that is fully approved and described in many medical references. It is used to lower high cholesterol levels and to reduce the risk of heart disease. The capsule works by inhibiting the liver enzyme that produces cholesterol, placing it in the statin class of lipid‑lowering drugs.

Investigated diseases

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.