6-week Safety and PD Study in Adults With NAFLD

Phase 2 Completed 53 enrolled Pfizer

RandomizedParallel-groupOpen-labelBasic science

Summary

IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Timeline

Start: 2017-09-27
Primary completion: 2018-03-30
Completion: 2018-04-27

Outcome

Met primary endpoint

registry Placebo vs PF-06835919 300 mg; p = 0.0395; LS mean difference -18.73 (90% CI -33.55 to -3.90); ANCOVA NCT03256526 ↗

paper Compared with placebo, significant reductions in WLF were observed in participants receiving PF-06835919 300 mg (difference of -18.73%; p = 0.04), but not with 75 mg. PMID 35590219 ↗

Publications

Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06835919	Small molecule	75 mg	Oral
Subject	PF-06835919	Small molecule	300 mg	Oral