MK-8245 Clinical Trials

Size	Price	Qty
5mg	USD 270
50mg	USD 970

Clinical Trials

Multiple clinical trials sponsored by Merck Sharp & Dohme LLC evaluated MK-8245 as a potential treatment for type 2 diabetes mellitus. Several Phase I studies successfully completed evaluations of multiple-dose safety, tolerability, pharmacokinetics, and pharmacodynamics in patients. Additionally, a Phase IIa multicenter trial assessing efficacy and safety was terminated, concluding early-to-mid phase clinical development centered on glycemic control and metabolic parameters.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00972322	COMPLETED	Type 2 Diabetes Mellitus	Merck Sharp & Dohme LLC	2009-08-24	PHASE1
NCT00790556	COMPLETED	Type 2 Diabetes	Merck Sharp & Dohme LLC	2008-10	PHASE1
NCT00846391	TERMINATED	Type 2 Diabetes Mellitus	Merck Sharp & Dohme LLC	2008-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2018-09-10)

Check the MK-8245 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-8245 is a liver-targeted inhibitor of stearoyl-CoA desaturase 1 (SCD1) that potently binds the enzyme to block the desaturation of saturated fatty acids into monounsaturated fatty acids specifically within hepatic tissue. By selectively suppressing hepatic SCD activity and reducing lipid accumulation, MK-8245 enhances hepatic insulin sensitivity and improves glucose clearance, providing therapeutic rationale for its clinical evaluation in type 2 diabetes mellitus.

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>).