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Study of K-924 (ezetimibe and pitavastatin) in patients with high cholesterol who have an inadequate response to pitavastatin

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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 individuals with Hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. The research aims to evaluate the effectiveness and safety of a treatment called K-924, which contains two active substances, ezetimibe and pitavastatin. The study compares this combination to a medication known as pitavastatin, which is used by people to manage cholesterol levels.

Participants in the study will receive either the test drug, a comparator medication, or a placebo. The study period lasts for 12 weeks, during which the effects on LDL-C, which is often referred to as bad cholesterol, will be monitored. Other substances in the blood, such as HDL-C, triglycerides, and total cholesterol, may also be observed to see how they change during the course of the treatment.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>medication administration</b>
The 12-week treatment period begins with the administration of one of three options.
The first option is K-924, which is a 14 mg tablet taken by mouth.
The second option is Livazo 4 mg, which consists of 4 mg film-coated tablets taken by mouth.
The third option is a placebo, which is a substance that looks like the medication but contains no active ingredients.
Step 2
<b>monitoring and evaluations</b>
Blood tests are conducted to measure levels of LDL-C (often called bad cholesterol), HDL-C (good cholesterol), triglycerides (fats in the blood), and other related markers at week 6 and week 12.
During these visits, the effects on cholesterol levels and any adverse events (unwanted side effects) are recorded.
The LDL-C levels are measured to see if they reach specific target goals based on individual risk levels.
At the 12-week mark, final measurements of ApoB and other physiological values are taken to evaluate the results of the treatment.

Who can join the trial?

10 criteria

You must be at least 18 years old at the time of signing the informed consent form, which is the document used to agree to participate in the study.
You must have hypercholesterolemia, which is a medical condition where you have too much cholesterol in your blood.
You must have been following a specific diet or exercise program for at least 4 weeks before the study begins, and this routine must remain unchanged.
You must have been taking a stable dose of pitavastatin 4 mg per day for at least 4 weeks before your first visit.
Your LDL-C, which is often called "bad cholesterol," must meet specific levels based on your health risk category:
- For low risk, your LDL-C must be 116 mg/dL or higher.
- For moderate risk, your LDL-C must be 100 mg/dL or higher.
- For high risk, your LDL-C must be 70 mg/dL or higher.
- For very high risk, your LDL-C must be 55 mg/dL or higher.
- For extreme risk, your LDL-C must be 40 mg/dL or higher.
- You must have been taking one of the following statins (medicines used to lower cholesterol) for at least 2 weeks: atorvastatin (20 mg or more per day), pitavastatin (4 mg per day), rosuvastatin (5 mg or more per day), or simvastatin (40 mg or more per day).

Who cannot join the trial?

28 criteria

You cannot join if you have a history of myopathy (muscle disease or weakness) or rhabdomyolysis (a serious condition where damaged muscle tissue releases a protein into the blood that can damage the kidneys) caused by pitavastatin or ezetimibe.
You cannot join if you have a known hypersensitivity (an allergic reaction) to pitavastatin, ezetimibe, or any of the other ingredients used to make these medicines.
You cannot join if you have a serious hepatic disorder (liver disease), specifically those classified as Child-Pugh B or higher, or if you have a biliary obstruction (a blockage in the tubes that carry bile from the liver).
Pregnant women, women who are breastfeeding, or those planning to become pregnant or breastfeed cannot participate unless they agree to use effective contraception (birth control) before, during, and for at least 30 days after the study.
You cannot join if you did not follow your current pitavastatin treatment closely, defined as taking it less than 80% or more than 120% of the prescribed amount.
You cannot join if your CK (a type of enzyme used to measure muscle damage) levels are 3 times higher than the upper limit of normal (the highest level considered healthy).
You cannot join if your ALT and AST (two types of enzymes used to check liver health) are both 2 times higher than the upper limit of normal.
You cannot join if you have Type 1 diabetes or Type 2 diabetes that is poorly controlled, which is measured by an HbA1c (an average blood sugar level over three months) higher than 10%.
You cannot join if you have hypertension (high blood pressure) that is not well-controlled, defined by specific high readings of systolic blood pressure (pressure when the heart beats) or diastolic blood pressure (pressure when the heart rests).
You cannot join if you have kidney disease with an eGFR (a measure of how well the kidneys filter blood) lower than 30, or if you are on dialysis (a treatment to clean the blood when kidneys fail).
You cannot join if you have certain types of heart failure (a condition where the heart cannot pump blood well enough) classified as NYHA level III or higher.
You cannot join if you have had certain heart or blood vessel problems in the last 3 months, such as a myocardial infarction (heart attack), stroke, or major heart/vessel surgeries.
You cannot join if you are scheduled for a major surgery or a procedure to open up blood vessels, such as a PCI (a procedure to open blocked heart arteries).
You cannot join if you have thyroid disease (problems with the gland that controls metabolism), unless a doctor decides it is well-controlled.
You cannot join if you have homozygous familial hypercholesterolemia (a rare, genetic form of very high cholesterol).
You cannot join if you have had malignancy (cancer) within the last 5 years, except for certain stable or non-invasive types.
You cannot join if you have donated blood, had a major injury, had a blood transfusion, or had major surgery within the last 30 days.
You cannot join if you have had serious allergic reactions to medication in the past, such as anaphylactic shock (a severe, life-threatening allergic reaction).
You cannot join if you must take medications that are not allowed during the study.
You cannot join if your fasting serum TG (the amount of triglycerides, a type of fat, in your blood while not eating) is 400 mg/dL or higher.
You cannot join if you are undergoing or planning LDL-C apheresis (a process that removes "bad" cholesterol from the blood).
You cannot join if you have an infection from HIV-1 or HIV-2.
You cannot join if you have had or currently have an infection from HCV (Hepatitis C) or HBV (Hepatitis B).
You cannot join if you have an active HAV (Hepatitis A) infection or were recently cured of it.
You cannot join if you have malabsorption (difficulty absorbing nutrients from food) or have had surgeries like gastric bypass (a weight loss surgery) that change how your body absorbs things.
You cannot join if you have a history of alcoholism or drug addiction within the last 2 years.
You cannot join if you participated in another clinical trial recently or are planning to join another trial at the same time.
You cannot join if the study investigators decide you are not suitable for the trial.

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Verified sites

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

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Universitario Virgen De La Victoria
Malaga, Spain

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Investigated drugs

K-924
is a combination medicine that contains two different active ingredients, ezetimibe and pitavastatin, used together to help lower cholesterol levels in the blood.
Pitavastatin
is a medication used to help lower high cholesterol levels in the body.

What is already known about the treatment

Pitavastatin
This medication is taken as an oral film-coated tablet and is widely used in clinical practice to manage high cholesterol levels. It belongs to a class of drugs called statins, which work by blocking a specific enzyme in the liver that is responsible for producing cholesterol. By inhibiting this enzyme at the molecular level, the drug helps lower the amount of "bad" cholesterol in the bloodstream to reduce cardiovascular risks.
Ezetimibe
This medication is administered orally in tablet form and is a well-established treatment for reducing high cholesterol. It is classified as a cholesterol absorption inhibitor, working by targeting a specific protein in the small intestine to prevent the body from absorbing cholesterol from food. By blocking this absorption process, the drug helps lower overall cholesterol levels in the blood.

Investigated diseases

Hypercholesterolemia - This condition is characterized by having abnormally high levels of cholesterol in the blood. It occurs when the body produces too much cholesterol or when the system cannot effectively remove it. Over time, these elevated levels can lead to the buildup of fatty deposits within the blood vessels. This buildup can gradually narrow the pathways through which blood flows. The condition often progresses silently without obvious physical symptoms.