RecruitingPhase 3NCT07614958

Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days

A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk

Sponsor

A. Menarini International Licensing S.A.

Enrollment

426 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

Hypercholesterolaemia mixed dyslipidemia

Summary

This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy. The primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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:
Are not pregnant;
Are not breastfeeding; and
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 Criteria9

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;