Cetilistat Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

A completed Phase 1 clinical trial sponsored by Alizyme evaluated the therapeutic application of cetilistat in individuals diagnosed with obesity. This study focused on characterizing the repeat-dose pharmacokinetic and pharmacodynamic profiles across distinct dosage regimens of the inhibitor. Overall, documented clinical research for cetilistat remains centered on early-phase evaluation for the management of obesity.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00148382	Completed	Obesity	Alizyme	2005-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cetilistat acts as a highly lipophilic benzoxazinone derivative that selectively inhibits gastrointestinal and pancreatic lipases, thereby preventing the enzymatic breakdown and hydrolysis of dietary triglycerides within the lumen of the digestive tract. By blocking the intestinal absorption of unhydrolyzed dietary fats, this mechanism reduces systemic caloric uptake and promotes fecal lipid excretion, which directly correlates with its therapeutic investigation for obesity.

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>).