Clinical Trials

Ervogastat (PF-06865571) has been evaluated in several clinical trials sponsored by Pfizer, all of which have reached completed status. These Phase 1 and Phase 1b studies investigated the agent's pharmacokinetic interactions with metformin in healthy participants, as well as its safety, tolerability, and pharmacodynamics in patients diagnosed with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03593707 Completed
Healthy Volunteers
Pfizer
 2018-08-17 Phase 1
NCT03513588 Completed
Non-alcoholic Steatohepatitis|Non-alcoholic Fatty Liver Disease
Pfizer
 2018-06-21 Phase 1

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

Check the Ervogastat (PF-06865571) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ervogastat selectively binds to and inhibits diacylglycerol acyltransferase 2 (DGAT2), thereby blocking the final step of hepatic triglyceride synthesis and reducing intracellular lipid accumulation. By suppressing hepatic triglyceride accumulation and lipotoxicity, this targeted mechanism reduces liver steatosis, providing therapeutic rationale for clinical trials evaluating non-alcoholic steatohepatitis and non-alcoholic fatty liver disease.

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.