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CompletedNCT01860729Updated May 29, 2020

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy (MK-0859-022)

A Phase 3 interventional study of Anacetrapib and Placebo in Hypercholesterolemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-29.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
589
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 589 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
589 participants (actual)

Study arms

  • Experimental
    Anacetrapib

    100 mg tablet, oral, once daily for 24 weeks

    Drug: Anacetrapib

  • Placebo comparator
    Placebo

    Matching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks

    Drug: Placebo

Interventions

  • DrugAnacetrapib

    Also known as: MK-0859

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)

    Time frame: Baseline and Week 24

  2. Percent Change from Baseline in HDL-C

    Time frame: Baseline and Week 24

  3. Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)

    Time frame: 24 weeks

  4. Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms

    Time frame: 24 weeks

  5. Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)

    Time frame: 24 weeks

  6. Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause

    Time frame: 24 weeks

  7. Number of Participants with Significant Increase in Blood Pressure

    Time frame: 24 weeks

Secondary outcomes

  1. Percent Change from Baseline in non-HDL-C

    Time frame: Baseline and Week 24

  2. Percent Change from Baseline in Apolipoprotein B (Apo-B)

    Time frame: Baseline and Week 24

  3. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)

    Time frame: Baseline and Week 24

  4. Percent Change from Baseline in Lipoprotein(a) (lp[a])

    Time frame: Baseline and Week 24

  5. Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal

    Time frame: Baseline and Week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ballantyne CM, Shah S, Sapre A, Ashraf TB, Tobias SC, Sahin T, Ye P, Dong Y, Sheu WH, Kang DH, Ferreira Rossi PR, Moiseeva Y, Briones IR, Johnson-Levonas AO, Mitchel YB. A Multiregional, Randomized Evaluation of the Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients With Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Aug 15;120(4):569-576. doi: 10.1016/j.amjcard.2017.03.255. Epub 2017 Apr 12. PubMed 28624096 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01860729
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 23, 2013
Start date
May 13, 2013
Primary completion
May 29, 2015
Completion
Aug 20, 2015
Last update
May 29, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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