2-Week Study In People With Nonalcoholic Fatty Liver Disease

Phase 1 Completed 48 enrolled Pfizer

RandomizedParallel-groupDouble-blindBasic science

Summary

2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.

Timeline

Start: 2018-06-21
Primary completion: 2019-03-08
Completion: 2019-04-04

Outcome

Met primary endpoint

registry analysis (other test); Placebo vs PF-06865571 50 mg; p <0.001; Least Squares Mean Difference -24.34 (80% CI -31.28 to -16.70); ANCOVA NCT03513588 ↗

registry analysis (other test); Placebo vs PF-06865571 300 mg; p <0.001; Least Squares Mean Difference -33.91 (80% CI -39.78 to -27.47); ANCOVA NCT03513588 ↗

Publications

Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06865571	Small molecule	50 mg	Oral
Subject	PF-06865571	Small molecule	300 mg	Oral