Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020) (REALIZE)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hyperlipoproteinemia Type II; Hypercholesterolemia, Familial

Treatments: Drug: Placebo; Drug: Anacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01524289

2011-004525-27 (EudraCT Number)

0859-020

MK-0859-020 (Other Identifier)

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).

Enrollment: 306 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• If of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study
• Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH)
• Have been treated with an optimal dose of statin for at least 6 weeks

Exclusion criteria

• Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of screening or expect to undergo treatment with LDL apheresis during the course of the study
• Homozygous familial hypercholesterolemia
• Severe chronic heart failure
• Uncontrolled hypertension
• Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), unstable angina, or stroke within 3 months
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
• Active or chronic hepatobiliary, hepatic, or gall bladder disease
• Pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 2 patient groups, including a placebo group

Anacetrapib

Experimental group

Description:

Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment period.

Treatment:

Drug: Anacetrapib

Placebo

Placebo Comparator group

Description:

Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment period.

Treatment:

Drug: Placebo