Clinical Trials

PF-04620110 has been evaluated across several completed Phase 1 and Phase 1B clinical trials sponsored predominantly by Pfizer, with select early-phase studies conducted in partnership with Bristol-Myers Squibb. These trials investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple escalating oral doses to assess therapeutic safety and metabolic bioactivity. Study populations included healthy volunteers, overweight or obese individuals, and patients with type 2 diabetes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01474941 COMPLETED
Healthy
Pfizer
 2011-06 PHASE1
NCT01298518 COMPLETED
Type 2 Diabetes Patients
Pfizer
 2011-02 PHASE1
NCT01298518 Completed
Type 2 Diabetes Patients
Pfizer
 2011-02 Phase 1
NCT01146327 COMPLETED
Healthy
Pfizer
 2010-06 PHASE1
NCT01166217 COMPLETED
Healthy
Pfizer
 2010-07 PHASE1
NCT01166217 Completed
Healthy
Pfizer|Bristol-Myers Squibb
 2010-07 Phase 1
NCT01146327 Completed
Healthy
Pfizer|Bristol-Myers Squibb
 2010-06 Phase 1
NCT00959426 COMPLETED
Obesity; Overweight; Healthy
Pfizer
 2009-08 PHASE1
NCT01064492 COMPLETED
Healthy Volunteers
Pfizer
 2010-02 PHASE1
NCT01064492 Completed
Healthy Volunteers
Pfizer
 2010-02 Phase 1
NCT00959426 Completed
Obesity|Overweight|Healthy
Pfizer|Bristol-Myers Squibb
 2009-08 Phase 1
NCT00799006 COMPLETED
Overweight
Pfizer
 2008-11 PHASE1
NCT00799006 Completed
Overweight
Pfizer
 2008-11 Phase 1

(data from https://clinicaltrials.gov, updated on 2012-01-26)

Check the PF-04620110 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-04620110 acts as a potent and selective diglyceride acyltransferase-1 inhibitor with an IC50 of 19 nM that directly binds DGAT1 to block the terminal enzyme-catalyzed step of intracellular triglyceride synthesis. By suppressing triglyceride formation and reducing postprandial lipemia, this mechanism targets lipid accumulation pathways relevant to metabolic diseases such as obesity and type 2 diabetes.

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>).

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Note: Technical data last updated: Sep 1, 2026.