Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifyi… (NCT06005597) | Clinical Trial Compass
CompletedPhase 3
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
United States407 participantsStarted 2024-03-01
Plain-language summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
* On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
* LDL-C ≥ 70 mg/dL
* Triglycerides \< 500
* Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2
Exclusion Criteria:
* History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction \<30%
* Hospitalized for heart failure within the last 5 years
* Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
* Uncontrolled severe hypertension
* Diagnosis of homozygous FH
* Liver disease
* HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
* Thyroid-stimulating hormone \>1.5 x upper limit of normal (ULN)
* History of malignancy
* Creatinine kinase (CK) \>3 X ULN
* Alcohol abuse
* Treatment with investigational product
* Treatment with gemfibrozil or ezetimibe
* Previous participation in a trial evaluating obicetrapib
* Known allergy to study drugs, placebo or excipients in study drugs of placebo
* Other condition that would interfere with the conduct of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
Timeframe: 84 Days
2
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
Timeframe: 84 Days
3
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
Timeframe: 84 Days
4
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C