Actively Recruiting
A Double-Blind, Randomized Study Comparing Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Adults With Dyslipidemia at High Cardiovascular Risk
Led by A. Menarini International Licensing S.A. · Updated on 2026-05-29
426
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
A. Menarini International Licensing S.A.
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two drugs, obicetrapib and bempedoic acid, in adults with dyslipidemia who have a high or very high risk of cardiovascular disease. The study focuses on participants who have high levels of low-density lipoprotein cholesterol (LDL-C) despite taking the best possible lipid-lowering treatments. This Phase 3, randomized, double-blind study aims primarily to compare how much these drugs lower LDL-C after 12 weeks of treatment. Participants will be randomly assigned to take either obicetrapib 10 mg with a placebo for bempedoic acid or bempedoic acid 180 mg with a placebo for obicetrapib. Both medications are taken orally once a day. The treatment period lasts approximately 84 days (12 weeks), during which researchers will monitor and compare the effects of these two drugs on cholesterol levels. Throughout the study, participants will have their LDL-C levels measured at the start and after 84 days to assess the primary outcome. Other key outcomes will also be evaluated during this period. The study includes ongoing safety monitoring and assessments of lipid levels while participants continue their usual lipid-lowering therapies. Total participation time is approximately 12 weeks, during which participants will attend scheduled visits for evaluations and tests.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Females must not be pregnant, breastfeeding, or planning pregnancy during the study
- Diagnosed with primary non-familial hypercholesterolemia or mixed dyslipidemia at high to very high cardiovascular risk
- On stable maximally tolerated lipid-lowering therapy for at least 8 weeks before screening
- Fasting LDL-C between 70 mg/dL and less than 130 mg/dL at screening
- Fasting triglycerides below 500 mg/dL at screening
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher at screening
You will not qualify if you...
- History of severe heart failure (New York Heart Association class III or IV) or left ventricular ejection fraction below 30%
- Hospitalization for heart failure within 5 years before screening
- Major cardiovascular events (heart attack, stroke, coronary revascularization, unstable angina) within 3 months before screening
- Uncontrolled severe high blood pressure
- Confirmed familial hypercholesterolemia diagnosis
- Active liver disease
- HbA1c level 8.0% or higher or fasting glucose 270 mg/dL or higher at screening
- History of cancer requiring major treatment in the past 3 years
- Complete intolerance to statin medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 84 days
Participants receive either Obicetrapib or Bempedoic Acid once daily alongside their current lipid-lowering therapy.
Visits scheduled as per study requirements during the treatment period
Trial Site Locations
Total: 1 location
1
FutureMeds North Tees
Stockton-on-Tees, United Kingdom, TS19
Actively Recruiting
Research Team
A
Andrea Conte, Medical Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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