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Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)

Primary Purpose

Hyperlipoproteinemia Type II, Homozygous Familial Hypercholesterolemia

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anacetrapib
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipoproteinemia Type II focused on measuring HoFH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with HoFH by genotyping
  • If female, cannot be of reproductive potential
  • Have been stabilized on statin monotherapy or statin therapy coadministered

with other lipid medications for at least 6 weeks

Exclusion Criteria:

  • Severe chronic heart failure defined by New York Heart Association

(NYHA) Classes III or IV

  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary arterial by-pass graft (CABG), unstable angina or stroke within 3 months prior to Visit 1 or has planned procedures scheduled within first 12 weeks of study
  • Uncontrolled endocrine or metabolic disease known to influence serum

lipids or lipoproteins

  • Active or chronic hepatobiliary or gall bladder disease
  • History of ileal bypass, gastric bypass, or other significant condition

associated with malabsorption

  • Human immunodeficiency virus (HIV) positive
  • 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
  • Taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4), 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. Consumption of >1 liter of grapefruit juice per day is also prohibited.
  • Currently participating or has participated in a study with an investigational compound or device within 3 months
  • Consume more than 2 alcoholic drinks per day
  • Receiving treatment with systemic corticosteroids or systemic anabolic agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Anacetrapib

    Placebo

    Arm Description

    Participants receive anacetrapib 100 mg orally once daily for 12 weeks.

    Participants receive placebo orally once daily for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Percent change from Baseline in Low-density Lipoprotein-Cholesterol (LDL-C) using beta-quantification method
    Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)
    Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
    Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)
    Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
    Number of Participants with Significant Increase in Blood Pressure

    Secondary Outcome Measures

    Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    Percent Change from Baseline in Apolipoprotein A-I (apoA-I)

    Full Information

    First Posted
    April 24, 2013
    Last Updated
    May 29, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01841684
    Brief Title
    Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
    Official Title
    A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Lipid-Lowering Therapy in Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipoproteinemia Type II, Homozygous Familial Hypercholesterolemia
    Keywords
    HoFH

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anacetrapib
    Arm Type
    Experimental
    Arm Description
    Participants receive anacetrapib 100 mg orally once daily for 12 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants receive placebo orally once daily for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Anacetrapib
    Other Intervention Name(s)
    MK-0859
    Intervention Description
    100 mg tablet orally, once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo for anacetrapib orally, once daily for 12 weeks
    Primary Outcome Measure Information:
    Title
    Percent change from Baseline in Low-density Lipoprotein-Cholesterol (LDL-C) using beta-quantification method
    Time Frame
    Baseline and Week 12
    Title
    Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)
    Time Frame
    12 weeks
    Title
    Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
    Time Frame
    12 weeks
    Title
    Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)
    Time Frame
    12 weeks
    Title
    Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
    Time Frame
    12 weeks
    Title
    Number of Participants with Significant Increase in Blood Pressure
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    Time Frame
    Baseline and Week 12
    Title
    Percent Change from Baseline in Apolipoprotein A-I (apoA-I)
    Time Frame
    Baseline and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with HoFH by genotyping If female, cannot be of reproductive potential Have been stabilized on statin monotherapy or statin therapy coadministered with other lipid medications for at least 6 weeks Exclusion Criteria: Severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary arterial by-pass graft (CABG), unstable angina or stroke within 3 months prior to Visit 1 or has planned procedures scheduled within first 12 weeks of study Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins Active or chronic hepatobiliary or gall bladder disease History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption Human immunodeficiency virus (HIV) positive 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 Taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4), 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. Consumption of >1 liter of grapefruit juice per day is also prohibited. Currently participating or has participated in a study with an investigational compound or device within 3 months Consume more than 2 alcoholic drinks per day Receiving treatment with systemic corticosteroids or systemic anabolic agents

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)

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