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 study testing Anacetrapib in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Anacetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 589 participants
Where: No sites listed yet
Study dates: 13 May 2013to 20 Aug 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

About this study

Official title: A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo- Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Hypercholesterolemia or Low HDL-C

Conditions: Hypercholesterolemia
Being tested: Anacetrapib, Placebo
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnacetrapibDrug
Also called MK-0859
PlaceboDrug

Study groups in NCT01860729
Study group	Role	What they receive
Anacetrapib	Experimental	100 mg tablet, oral, once daily for 24 weeks Receives: Drug: Anacetrapib
Placebo	Placebo comparator	Matching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
Measured: Baseline and Week 24
Percent Change from Baseline in HDL-C
Measured: Baseline and Week 24
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)
Measured: 24 weeks
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
Measured: 24 weeks
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)
Measured: 24 weeks
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
Measured: 24 weeks
Number of Participants with Significant Increase in Blood Pressure
Measured: 24 weeks

Secondary outcomes (5)

Percent Change from Baseline in non-HDL-C
Measured: Baseline and Week 24
Percent Change from Baseline in Apolipoprotein B (Apo-B)
Measured: Baseline and Week 24
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
Measured: Baseline and Week 24
Percent Change from Baseline in Lipoprotein(a) (lp[a])
Measured: Baseline and Week 24
Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 201320 Aug 2015

First posted23 May 2013 (estimated)
Study start13 May 2013
Primary completion29 May 2015
Study completion20 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 589 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01860729
Sponsor's protocol ID: 0859-022
Status last verified: May 2020
First submitted: 20 May 2013
Last updated: 29 May 2020
Results posted: No
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo- Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Hypercholesterolemia or Low HDL-C
ClinicalTrials.gov ID: NCT01860729
Acronym / sponsor ID: 0859-022
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 589 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 13 May 2013 (actual)
Primary completion: 29 May 2015 (actual)
Study completion: 20 Aug 2015 (actual)
First posted: 23 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Anacetrapib	Experimental	Drug: Anacetrapib100 mg tablet, oral, once daily for 24 weeks
Placebo	Placebo comparator	Drug: PlaceboMatching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AnacetrapibAlso: MK-0859	Drug	Anacetrapib
Placebo	Drug	Placebo

Primary outcome

Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
Time frame: Baseline and Week 24
Percent Change from Baseline in HDL-C
Time frame: Baseline and Week 24
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)
Time frame: 24 weeks
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
Time frame: 24 weeks
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)
Time frame: 24 weeks
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
Time frame: 24 weeks
Number of Participants with Significant Increase in Blood Pressure
Time frame: 24 weeks

5 secondary outcomes

Percent Change from Baseline in non-HDL-C
Time frame: Baseline and Week 24
Percent Change from Baseline in Apolipoprotein B (Apo-B)
Time frame: Baseline and Week 24
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
Time frame: Baseline and Week 24
Percent Change from Baseline in Lipoprotein(a) (lp[a])
Time frame: Baseline and Week 24
Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal
Time frame: Baseline and Week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
Results publication: PubMed 28624096Ballantyne 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.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anacetrapib in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) (time frame: Baseline and Week 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.