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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
DIEKO s.r.o.	Plzen	Czechia

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Edumed s.r.o.	Nachod	Czechia
Cardio D&R s.r.o. Kosice	Kosice	Slovakia
Doctor Mn s.r.o.	Caslav	Czechia
Medika Hradec Kralove s.r.o.	Hradec Kralove	Czechia
JAL s.r.o.	Trnava	Slovakia
Dia Gnosis s.r.o.	Piestany	Slovakia
Human-Care s.r.o.	Kosice	Slovakia
Pratia Pardubice a.s.	Pardubice	Czechia
Deventer Ziekenhuis	Deventer	The Netherlands
Nemocnicna a.s.	Malacky	Slovakia
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
MUDr. Alena Vachova	Ceske Budejovice	Czechia
Nemocnice Na Frantisku	Prague	Czechia
Bethesda Diabetes Research Center B.V.	Hoogeveen	The Netherlands
Diavital Jesenice s.r.o.	Jílové u Prahy	Czechia
Iqdpmshhz Fba Clfahddd Adt Etpsfoctgqoz Mdnyewoh	Prague	Czechia
Rqoellogw Znzpufltbu Sbwltojkl	Arnhem	The Netherlands
Dggh Sbunkv sukpym	Humpolec	Czechia
Mxrow Zeddmy sjblky	Trencin	Slovakia
Ftydjmxgsi sowmh	Nove Zamky	Slovakia
Mkwtz Tysvx Ewmbhtabmcp	Krnov	Czechia
Fattwfcv ncuomrenv Mzler a Hyqfend	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.04.2026
Slovakia	Recruiting	01.04.2026
The Netherlands	Not yet recruiting	01.04.2026

Trial locations

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.

Investigated diseases:

Type 2 diabetes mellitus

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.

Trial ID:

2025-521936-12-00

Protocol code:

OBEZ-303

NCT ID:

NCT07219602

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?