Hypercholesterolaemia, Mixed Dyslipidemia
Conditions
Keywords
Bempedoic Acid, Obicetrapib, Hypercholesterolaemia, Mixed Dyslipidemia
Brief 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
Interventions
DRUGObicetrapib 10 mg/Bempedoic Acid Placebo
Orally, Once Daily
DRUGBempedoic Acid 180mg/Placebo Obicetrapib
Orally, Once Daily
Sponsors
A. Menarini International Licensing S.A.
Medpace, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomization: Participants are randomized 1:1 to receive either: Group 1: Obicetrapib + Placebo (matching BPA) Group 2: Bempedoic Acid + Placebo (matching OBI)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the percentage change from baseline to Day 84 in LDL-C in the OBI group compared to the BPA group. | 84 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group | 84 days |
| Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group; | 84 days |
| Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group; | 84 days |
| Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group; | 84 days |
| Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; | 84 days |
| Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group. | 84 days |
Countries
United Kingdom
Contacts
CONTACTAndrea Conte, Medical Doctor
Outcome results
None listed