CompletedNCT00990808Updated Jun 4, 2015

The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

A Phase 1 interventional study of anacetrapib and Comparator: atorvastatin in Dyslipidemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-04.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.

Conditions studied

Dyslipidemia

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Dyslipidemias 1,073

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 46 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias 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.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient's weight has been stable for at least 6 weeks
Patient is in good health based on medical history, physical exam, and laboratory tests
Patient has dyslipidemia

Exclusion criteria

Exclusion Criteria :

Patient has a history of stroke, seizures, or major neurological disorders
Patient has a history of cancer
Patient is currently taking any lipid-lowering medications or substances except for statins
Patient consumes excessive amounts of alcohol or caffeine
Patient has multiple and/or severe allergies to food or drugs

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 46 participants (actual)

Study arms

Experimental
Panel A
Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
Drug: anacetrapib · Drug: Comparator: atorvastatin · Drug: Comparator: placebo to MK0859
Experimental
Panel B
Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin
Drug: anacetrapib · Drug: Comparator: placebo to MK0859 · Drug: Comparator: placebo to atorvastatin

Interventions

Druganacetrapib
\[Intervention Name: MK0859\] MK0859 100 mg tablet once daily for 8 weeks.
DrugComparator: atorvastatin
Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
DrugComparator: placebo to MK0859
Placebo to MK0859 once daily for 4 weeks.
DrugComparator: placebo to atorvastatin
Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.

What researchers measure

Primary outcomes

Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
Time frame: 12 weeks

Secondary outcomes

Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo
Time frame: 12 weeks

Study locations

No study locations are listed for this record.

References and documents

Publications

Millar JS, Reyes-Soffer G, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Pollan L, Tohyama J, Johnson-Levonas AO, Wagner JA, Holleran S, Obunike J, Liu Y, Ramakrishnan R, Lassman ME, Gutstein DE, Ginsberg HN, Rader DJ. Anacetrapib lowers LDL by increasing ApoB clearance in mildly hypercholesterolemic subjects. J Clin Invest. 2015 Jun;125(6):2510-22. doi: 10.1172/JCI80025. Epub 2015 May 11. Erratum In: J Clin Invest. 2016 Apr 1;126(4):1603-4. doi: 10.1172/JCI87364. PubMed 25961461 ↗
Thomas T, Zhou H, Karmally W, Ramakrishnan R, Holleran S, Liu Y, Jumes P, Wagner JA, Hubbard B, Previs SF, Roddy T, Johnson-Levonas AO, Gutstein DE, Marcovina SM, Rader DJ, Ginsberg HN, Millar JS, Reyes-Soffer G. CETP (Cholesteryl Ester Transfer Protein) Inhibition With Anacetrapib Decreases Production of Lipoprotein(a) in Mildly Hypercholesterolemic Subjects. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1770-1775. doi: 10.1161/ATVBAHA.117.309549. Epub 2017 Jul 20. PubMed 28729361 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00990808
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Oct 7, 2009
Start date: Nov 2009
Primary completion: Jun 2011
Completion: Jul 2011
Last update: Jun 4, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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