ClinicaliQ Trial Snapshot
- 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 —….
- What is being tested: Obicetrapib (OBI), a novel CETP inhibitor, is being directly compared to bempedoic acid (BPA) for reducing LDL-cholesterol in adults with primary non-familial hypercholesterolemia or mixed dyslipidemia over 84 days in a randomized, double-blind Phase 3 trial.
- Patient eligibility overview: Adults with dyslipidemia at high or very high cardiovascular risk who have elevated LDL-cholesterol levels are eligible; this typically includes patients on existing lipid-lowering therapy or those who require additional cholesterol management beyond current treatment options.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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 Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.