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A study to evaluate the effects of obicetrapib and ezetimibe on cholesterol levels in adults with type 2 diabetes or metabolic syndrome

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What is this trial about?

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

This study is designed to evaluate the effect of certain medications on LDL-C, which is often called "bad cholesterol." The research focuses on individuals living with Type 2 Diabetes or Metabolic Syndrome, a group of conditions that increase the risk of health problems like heart disease. Participants in this study are already receiving standard treatments to lower their lipid levels, which are the fats found in the blood.

The study compares the effects of different treatment options. One group may receive a combination of Obicetrapib and Ezetimibe in a single tablet, while another group receives Obicetrapib alone. Other participants may receive a placebo. Throughout the course of the study, participants will take these tablets daily to see how they influence various types of cholesterol and other related markers in the blood.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation and treatment assignment
Once participation begins, an assignment to a specific treatment group is made. this assignment is random and follows a double-blind process, meaning neither the participant nor the medical staff knows which specific substance is being administered.
One of three possible treatment paths is followed: receiving obicetrapib 10 mg as a single tablet, receiving a combination of obicetrapib 10 mg and ezetimibe 10 mg in one tablet, or receiving a placebo, which is a tablet that contains no active medicine.
Step 2
Daily medication administration
The assigned medication is taken by oral use, meaning it is swallowed as a tablet once every day.
The obicetrapib 10 mg dose or the obicetetrapib 10 mg and ezetimibe 10 mg fixed-dose combination is administered daily to evaluate its effect on low-density lipoprotein cholesterol (LDL-C), which is often referred to as bad cholesterol.
Step 3
Monitoring and assessment period
The active treatment phase lasts for 84 days.
During this 84-day period, changes in various blood levels are monitored, including LDL-C, non-HDL-C (other types of cholesterol), HDL-C (often called good cholesterol), ApoB and ApoA1 (proteins related to cholesterol), and lipoprotein (a).
Additional measurements may be taken to track levels of HbA1c (a measure of long-term blood sugar) and other substances like triglycerides and total cholesterol.

Who can join the trial?

10 criteria

You must be willing and able to provide written informed consent, which means you agree to participate after being fully told about the study, and you must follow all the study rules.
You must be at least 18 years old.
Women must not be pregnant, must not be breastfeeding, and must not plan to become pregnant during the study.
Women of childbearing age and men with partners of childbearing age must use certain contraceptives (methods to prevent pregnancy) as required by the study.
You must have been diagnosed with type 2 diabetes for at least 6 months.
Or, you must have metabolic syndrome, which is a group of conditions that increase the risk of heart disease. This requires a specific level of fasting triglycerides (a type of fat in your blood) and at least two of the following: high blood sugar, low HDL-C (often called "good" cholesterol), a large waist circumference, hypertension (high blood pressure), or microalbuminuria (a sign of kidney stress found in urine).
Your LDL-C, which is often called "bad" cholesterol, must be at or above 70 mg/dL when tested after not eating.
Your fasting triglycerides, which are a type of fat found in your blood, must be between 150 mg/dL and 400 mg/dL when tested after not eating.
You must be taking a stable dose of lipid-lowering therapy, which is medication used to lower fat levels in the blood, such as a statin, bempedoic acid, or a PCSK9-targeted therapy, for a specific amount of time.
Your eGFR, which is a measure of how well your kidneys are filtering your blood, must be 15 mL/min/1.73 m2 or higher.

Who cannot join the trial?

20 criteria

You have a history of severe heart failure, which is a condition where the heart cannot pump blood well enough to meet the body's needs, specifically classified as class III or IV, or if your left ventricular ejection fraction (a measurement of how much blood the heart pumps out with each beat) is less than 30%.
You have a known history of alcohol or drug abuse within the last 5 years.
You have used other investigational products (experimental medicines or medical devices being tested in studies) within the last 30 days or within a specific timeframe based on how long the previous medicine stays in your system.
You are currently taking, or have taken within the last 30 days, gemfibrozil (a medication used to lower lipids/fats in the blood).
You are currently taking, or have taken within the last 14 days, ezetimibe (a medication used to lower cholesterol).
You have had weight loss surgery, such as a sleeve gastrectomy or Roux-en-Y, within the last 12 months, or you plan to have this surgery during the study.
You are currently in, or have been in within the last 3 months, a weight loss program, or you plan to join one during the study.
You have experienced a significant weight change, meaning your body weight changed by more than 5% in the 3 months before the study begins.
You plan to use other investigational products or devices while participating in this study.
You have previously participated in any clinical study that tested obicetrapib.
You have a known allergy or hypersensitivity (an extreme immune reaction) to the study drugs, a placebo (an inactive substance used as a control), or any of the inactive ingredients used to make them.
You have been hospitalized for heart failure within the last 5 years.
You have any condition that makes it difficult to communicate, cooperate, or follow the study instructions, or if the doctor believes participating would put you at increased risk.
You have uncontrolled severe hypertension, which means very high blood pressure (systolic pressure of 160 mmHg or higher, or diastolic pressure of 100 mmHg or higher).
You have a formal diagnosis of homozygous familial hypercholesterolemia (a rare genetic condition that causes very high cholesterol levels from birth).
You have active liver disease, which includes infections, tumors, or metabolic issues of the liver, or specific high levels of liver enzymes like ALT or AST, or high levels of bilirubin (a substance produced when red blood cells break down).
Your HbA1c (a blood test that shows your average blood sugar levels over the past few months) is 10.0% or higher.
Your thyroid-stimulating hormone (a hormone that tells your thyroid gland to work) levels are more than 1.5 times the normal limit.
Your creatine kinase (an enzyme found in the heart and muscles) levels are more than 5 times the normal limit.
You have a history of malignancy (cancer) that required surgery, radiation, or systemic therapy (such as chemotherapy) within the last 3 years.

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Verified sites

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

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Albert Schweitzer Ziekenhuis
Dordrecht, The Netherlands
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Fakultni nemocnice Motol a Homolka
Prague, Czechia
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Institute For Clinical And Experimental Medicine
Prague, Czechia

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Investigated drugs

Obicetrapib
is a medication taken by mouth that is being studied for its ability to help lower low-density lipoprotein cholesterol (often called "bad" cholesterol) in patients.
Obicetrapib
and ezetimibe is a combination therapy taken by mouth that includes two different medicines in one tablet to help lower "bad" cholesterol levels.

What is already known about the treatment

Obicetrapib
This medication is taken as a tablet by mouth and is currently being studied in clinical trials to help lower bad cholesterol. It belongs to a group of drugs known as CETP inhibitors, which work by blocking a specific protein in the blood that helps move cholesterol away from the arteries. By preventing this protein from working, the medication helps increase the levels of good cholesterol and reduce the amount of harmful cholesterol in the body.
Ezetimibe
This is an oral tablet used to help lower cholesterol levels in the blood. It is a well-established medication that works by blocking the absorption of cholesterol from the food you eat within the small intestine. By reducing the amount of cholesterol that enters your system from your diet, it helps keep overall cholesterol levels in a healthier range.

Investigated diseases

Type 2 Diabetes - This is a chronic condition that affects how the body processes blood sugar. It occurs when the body cannot properly use insulin or cannot make enough of it to maintain healthy glucose levels. Over time, high blood sugar levels can lead to various complications throughout the body. The condition often progresses gradually and is closely linked to metabolic functions. Metabolic Syndrome - This is a cluster of several conditions that occur together, increasing the risk of health issues. These conditions include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels. The presence of these factors together signifies a disruption in the body's normal metabolic processes. It typically progresses as these individual health markers become increasingly unbalanced.