Obicetrapib vs. bempedoic acid for high-risk high cholesterol patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, active-controlled Phase 3 trial compares obicetrapib to bempedoic acid in adults with dyslipidemia at high or very high cardiovascular risk who remain above target LDL-C despite optimized lipid-lowering therapy. Participants receive either obicetrapib 10 mg or bempedoic acid 180 mg, with a matching placebo for the comparator, over about 12 weeks to assess LDL-C reduction. The primary goal is to determine which treatment lowers LDL-C more effectively at 12 weeks, while monitoring safety and tolerability. Eligible patients must have LDL-C in an elevated range, be on stable maximally tolerated therapy, and have adequate kidney function. The study is led by A. Menarini International Licensing with Medpace as a collaborator, at sites including FutureMeds North Tees in Stockton-on-Tees.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are male or female and ≥18 years of age at Screening (Visit 1);
* Females may be enrolled if all 3 of the following criteria are met:

  1. Are not pregnant;
  2. Are not breastfeeding; and
  3. Do not plan to become pregnant during the study.
* Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
* Are on stable maximally tolerated lipid-modifying therapy for at least 8 weeks prior to Screening (Visit 1) as an adjunct to a lipid-lowering diet and lifestyle modifications, defined as a maximum tolerated statin dose, with or without ezetimibe and/or a monoclonal PCSK9-targeted therapy for at least 4 stable doses prior to Screening (Visit 1);
* Have a fasting serum LDL-C at Screening (Visit 1) of ≥70 mg/dL (1.81 mmol/L) and \<130 mg/dL (3.37 mmol/L);
* Have fasting TGs \<500 mg/dL (\<5.7 mmol/L) at Screening (Visit 1); and
* Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).

Exclusion Criteria:

* Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction \<30%;
* Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
* Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
* Have uncontrolled severe hypertension;
* Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid Network criteria, Simon Broome, or MedPed;
* Have active liver disease;
* Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
* Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Screening (Visit 1);
* Have history of full statin intolerance;

Where it's running

• FutureMeds North Tees
  Stockton-on-Tees, United Kingdom Recruiting

Study contacts

• Study coordinator: Andrea Conte, Medical Doctor
• Email: aconte@menarini.lu
• Phone: +352 26497650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.