Hypercholesterolemia
Conditions
Brief summary
This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin therapy.
Interventions
DRUGAnacetrapib
DRUGPlacebo
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* If female, cannot be of reproductive potential * Has been treated with an appropriate dose of statin for at least 6 weeks * Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal
Exclusion criteria
* Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor * Homozygous familial hypercholesterolemia * Severe chronic heart failure * Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months * Uncontrolled hypertension * Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * Active or chronic hepatobiliary, hepatic, or gall bladder disease * History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable * History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption * Human immunodeficiency virus (HIV) positive * History of malignancy ≤5 years * Donated blood products or has had phlebotomy of \>300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study * Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment \<3 weeks prior * Consumes more than 2 alcoholic drinks per day * Currently participating or has participated in a study with an investigational compound or device within 3 months * Receiving treatment with systemic corticosteroids or taking systemic anabolic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Significant Increase in Blood Pressure | 24 weeks |
| Percent Change from Baseline in HDL-C | Baseline and Week 24 |
| Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN) | 24 weeks |
| Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms | 24 weeks |
| Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN) | 24 weeks |
| Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause | 24 weeks |
| Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) | Baseline and Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Apolipoprotein B (Apo-B) | Baseline and Week 24 |
| Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) | Baseline and Week 24 |
| Percent Change from Baseline in Lipoprotein(a) (lp[a]) | Baseline and Week 24 |
| Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal | Baseline and Week 24 |
| Percent Change from Baseline in non-HDL-C | Baseline and Week 24 |
Outcome results
None listed