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Comparison of Obicetrapib and Bempedoic Acid in Patients with Dyslipidemia at High to Very High Cardiovascular Risk

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What is this trial about?

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

The trial involves adults who have dyslipidemia at high to very high cardiovascular risk, a condition where the blood contains too much unhealthy cholesterol. Participants receive either the experimental pill Obicetrapib taken once daily, or the approved medicine bempedoic acid taken once daily, each added to the cholesterol‑lowering drugs they already use. Some participants receive a matching inactive tablet (placebo) so that the study remains blinded.

The purpose of the study is to compare how well the two medicines lower the level of LDL-C after about 12 weeks. After a screening visit, participants are randomly assigned to one of the two groups. They take the assigned tablets every day for roughly three months, with clinic visits at the start, midway, and at the end to collect blood samples and check safety.

Safety is monitored through regular physical checks, blood pressure measurements, and laboratory tests that look for any side effects. The overall aim is to see which medicine provides a greater reduction in the harmful cholesterol while being well tolerated.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessments
After signing the consent form, baseline data are collected, including medical history, current medications, and blood samples to measure cholesterol levels.
The cholesterol measurements include ldl-c (the “bad” cholesterol), hdl-c (the “good” cholesterol), and other lipid values.
Step 2
Randomization and receipt of study medication
The participant is randomly assigned, in a double‑blind manner, to receive either the test medication obicetrapib 10 mg tablet, the comparator medication bempedoic acid 180 mg film‑coated tablet, or the matching placebo for each.
The study medication is taken orally once daily.
Step 3
Daily medication administration
The participant ingests one tablet each day for a total of 84 days.
If the assigned tablet is a placebo, it looks identical to the active tablet but does not contain the active ingredient.
Step 4
Scheduled follow‑up visits
Follow‑up visits occur at approximately day 28, day 56, and day 84 after the first dose.
Each visit includes a brief physical examination, vital‑sign check, and blood draw to repeat the cholesterol measurements.
The visits also include assessment of any adverse events (possible side effects) and review of concomitant medications.
Step 5
Primary efficacy assessment
On day 84 the change in ldl-c from the baseline value is calculated to determine the primary efficacy outcome.
Additional lipid parameters (such as non‑hdl‑c, hdl‑c, apoa1, apob, lpa, and triglycerides) are also evaluated.
Step 6
Study completion
After the final assessments, the participant stops the study medication.
The participant continues any previously prescribed lipid‑lowering therapy as directed by the regular health‑care provider.

Who can join the trial?

10 criteria

Willing and able to give written informed consent before any study procedures and to follow all study requirements (informed consent means you understand the study and agree in writing).
At least 18 years old at the screening visit.
Women who cannot become pregnant (non‑childbearing potential) may join if they have had a hysterectomy, removal of both fallopian tubes or ovaries at least 26 weeks before screening, or if they are postmenopausal (no periods for 12 months without another cause; a high FSH blood test can confirm menopause if not using hormones).
Women who could become pregnant (childbearing potential) may join if they have been sexually inactive (abstinent) for at least 90 days before the first dose and plan to remain abstinent, or if they use a highly effective birth‑control method (less than 1% failure when used correctly).
Men who are fertile must agree to use a highly effective birth‑control method from screening until 35 days after the last dose (a man is considered fertile after puberty unless he has had a vasectomy).
Must have primary non‑familial hypercholesterolemia (high cholesterol not caused by family genes) or mixed dyslipidemia (abnormal levels of different blood fats) and be at high to very high cardiovascular risk (risk of heart problems).
Must be on a stable, maximally tolerated lipid‑modifying therapy for at least 8 weeks, which can include the highest tolerated dose of a statin drug, with or without ezetimibe and/or a PCSK9‑inhibiting monoclonal antibody, taken consistently for at least 4 doses.
Must have a fasting LDL‑C (the “bad” cholesterol) level at screening of at least 70 mg/dL but less than 130 mg/dL.
Must have fasting triglycerides (TG) lower than 500 mg/dL at screening.
Must have an eGFR (estimated kidney filtration rate) of 30 mL/min/1.73 m² or higher, calculated using the CKD‑EPI equation at screening.

Who cannot join the trial?

20 criteria

Having current or past severe heart failure (New York Heart Association class III or IV) or a heart pumping ability called left ventricular ejection fraction that is less than 30%.
Being hospitalized for heart failure as the main reason within the past 5 years.
Having any of these serious heart or brain events within the past 3 months: a heart attack (myocardial infarction), a stroke, an emergency heart‑artery procedure (non‑elective coronary revascularization), or a hospital stay for unstable chest pain (unstable angina).
Having very high blood pressure, defined as a systolic pressure ≥ 160 mm Hg or a diastolic pressure ≥ 100 mm Hg, measured three times at the screening visit.
Having a confirmed diagnosis of definite familial hypercholesterolemia (inherited very high cholesterol) based on genetic testing.
Having active liver disease, which means a current infection, cancer, or metabolic problem of the liver, or having liver‑enzyme levels called alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than three times the normal upper limit, or a total bilirubin level more than twice the normal upper limit.
Having poor blood‑sugar control, shown by an HbA1c level ≥ 8.0% (a measure of average blood sugar over three months) or a fasting glucose level ≥ 270 mg/dL.
Having a thyroid‑stimulating hormone level that is more than 1.5 times the normal upper limit.
Having a creatine kinase (CK) level that is more than three times the normal upper limit (CK is an enzyme that rises when muscle is damaged).
Having a history of cancer that required major surgery (other than a small local removal), radiation therapy, or systemic treatment within the past 3 years.
Having a known history of alcohol or drug abuse within the past 5 years.
Having received any other experimental drug or device within 30 days before screening, or for a period equal to five half‑lives of the previous experimental product (the time it takes for half of the drug to leave the body).
Currently taking, or having taken within 30 days before screening, the medication gemfibrozil.
Having a full intolerance to statins (cannot take any statin medication at all).
Being treated with any of the following cholesterol medicines: simvastatin, pravastatin, pitavastatin, or inclisiran.
Planning to use other experimental products or devices during the study.
Having previously participated in any clinical study of OBI or having already been treated with BPA, either in a trial or as routine care.
Having a known allergy or severe reaction to OBI, BPA, or any of their inactive ingredients (excipients), including rare inherited conditions such as galactose intolerance, total lactase deficiency, or glucose‑galactose malabsorption.
Having any condition that, in the investigator’s judgment, could interfere with the conduct of the study.
Being committed to an institution by a court or administrative order, or being in a dependent relationship with the study sponsor or investigator.

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Verified sites

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

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Albert Schweitzer Ziekenhuis
Verified
Dordrecht, The Netherlands
Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland

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Investigated drugs

bempedoic acid
is a pill taken by mouth that helps lower “bad” cholesterol (LDL‑C). In this study it was used as the standard treatment to compare against the new drug. Participants continued their usual cholesterol‑lowering medicines and added bempedoic acid to see how well it could reduce LDL‑C levels over about three months.
Obicetrapib
is an experimental oral tablet that also aims to lower LDL‑C. In the trial it was the new therapy being tested. Patients already on the strongest cholesterol‑lowering regimen they could tolerate took obicetrapib in addition, and researchers measured how much it lowered LDL‑C compared with bempedoic acid.

What is already known about the treatment

Bempedoic acid
An oral film‑coated tablet of 180 mg taken once daily with or without food; it is an FDA‑approved medication used together with other cholesterol‑lowering drugs to reduce LDL‑cholesterol in people at high cardiovascular risk; it works by blocking the liver enzyme ATP‑citrate lyase, which decreases the body's production of cholesterol; it belongs to the class of ATP‑citrate lyase inhibitors, a type of cholesterol‑lowering agent.
Obicetrapib
An oral tablet of 10 mg taken once daily with or without food; it is an investigational drug currently being studied for its ability to lower LDL‑cholesterol in patients already on strong lipid‑lowering therapy; it lowers cholesterol by inhibiting the CETP protein, which helps keep more good cholesterol in the blood and reduces bad cholesterol; it is classified as a CETP inhibitor, a kind of lipid‑modifying medication.

Investigated diseases

Dyslipidemia - Dyslipidemia is a condition where blood contains abnormal amounts of lipids, such as cholesterol or triglycerides. It often develops gradually as diet, genetics, and lifestyle influence lipid levels. Over time, the excess lipids can accumulate in blood vessels, leading to plaque formation. This buildup can narrow arteries and reduce blood flow. The condition may progress without obvious symptoms, but the underlying changes continue as lipid levels remain high.