Anacetrapib (MK-0859) Clinical Trials

Size	Price	Qty
10mg	USD 370

Clinical Trials

Anacetrapib (MK-0859) has been evaluated across multiple clinical trials focusing on atherosclerotic cardiovascular disease, dyslipidemia, hypercholesterolemia, and familial hypercholesterolemia. Spanning Phase 1 pharmacokinetic evaluations in hepatic or renal impairment, Phase 2 dose-ranging, and Phase 3 outcome studies, these trials involved commercial and academic sponsors including Merck Sharp & Dohme LLC, the University of Oxford, and Cambridge University Hospitals NHS Foundation Trust. Recruitment statuses are predominantly completed or active and not recruiting, alongside select terminated protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01252953	ACTIVE_NOT_RECRUITING	Atherosclerotic Cardiovascular Disease	University of Oxford	2011-06	PHASE3
NCT01860729	COMPLETED	Hypercholesterolemia	Merck Sharp & Dohme LLC	2013-05-13	PHASE3
NCT01760460	COMPLETED	Dyslipidemia	Merck Sharp & Dohme LLC	2013-03-14	PHASE3
NCT01717300	COMPLETED	Hypercholesterolemia	Merck Sharp & Dohme LLC	2012-11-06	PHASE3
NCT01841684	TERMINATED	Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia	Merck Sharp & Dohme LLC	2013-06	PHASE3
NCT01824238	COMPLETED	Heterozygous Familial Hypercholesterolemia (HeFH)	Merck Sharp & Dohme LLC	2013-05	PHASE3
NCT01524289	COMPLETED	Hyperlipoproteinemia Type II; Hypercholesterolemia, Familial	Merck Sharp & Dohme LLC	2012-02-03	PHASE3
NCT00990808	COMPLETED	Dyslipidemia	Merck Sharp & Dohme LLC	2009-11	PHASE1
NCT01122667	COMPLETED	Dyslipidemia	Merck Sharp & Dohme LLC	2010-06	PHASE1
NCT01114490	COMPLETED	Dyslipidemia	Merck Sharp & Dohme LLC	2010-05	PHASE1
NCT01122667	Completed	Dyslipidemia	Merck Sharp & Dohme LLC	2010-06	Phase 1
NCT01114490	Completed	Dyslipidemia	Merck Sharp & Dohme LLC	2010-05	Phase 1
NCT00977288	COMPLETED	Dyslipidemia	Merck Sharp & Dohme LLC	2009-09	PHASE2
NCT00685776	COMPLETED	Coronary Heart Disease (CHD); CHD Risk-Equivalent Disease	Merck Sharp & Dohme LLC	2008-03-24	PHASE3
NCT00325455	TERMINATED	Hypercholesterolemia; Mixed Hyperlipemia	Merck Sharp & Dohme LLC	2006-06	PHASE2
NCT00565006	COMPLETED	Ambulatory Blood Pressure	Merck Sharp & Dohme LLC	2006-07	PHASE1
NCT00565292	COMPLETED	Hypercholesterolemia; Hyperlipidemia	Merck Sharp & Dohme LLC	2006-07	PHASE1
NCT00325455	Terminated	Hypercholesterolemia\|Mixed Hyperlipemia	Merck Sharp & Dohme LLC	2006-06	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-06-25)

Check the Anacetrapib (MK-0859) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anacetrapib (MK-0859) acts as a potent, selective, and reversible inhibitor of recombinant human cholesteryl ester transfer protein (rhCETP, IC50 = 7.9 nM) and mutant CETP(C13S, IC50 = 11.8 nM), which blocks the transfer of cholesteryl esters and triglycerides between high-density and low-density lipoprotein fractions. By suppressing CETP-mediated lipid exchange and promoting macrophage reverse cholesterol transport, Anacetrapib increases plasma high-density lipoprotein cholesterol while decreasing low-density lipoprotein cholesterol, directly targeting the atherogenic lipid profile characteristic of hypercholesterolemia and atherosclerotic cardiovascular disease evaluated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).