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PF-05221304

DRUG7 trials

Sponsors

Pfizer, Columbia University

Conditions

HealthyHepatic ImpairmentNAFLD (Nonalcoholic Fatty Liver Disease)NASH (Nonalcoholic Steatohepatitis)Nonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisNonalcoholic Steatohepatitis With Liver FibrosisNormal Healthy

Phase 1

Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
CompletedNCT02871037
PfizerNormal Healthy
Start: 2016-08-31End: 2017-03-31Updated: 2018-05-24
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
CompletedNCT03309202
PfizerHepatic Impairment
Start: 2017-12-19End: 2018-07-18Updated: 2019-08-08
A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults
CompletedNCT03597217
PfizerHealthy
Start: 2018-08-27End: 2018-11-15Updated: 2018-11-27
Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism
WithdrawnNCT04395950
Columbia UniversityNAFLD (Nonalcoholic Fatty Liver Disease), NASH (Nonalcoholic Steatohepatitis)
Start: 2020-12-31End: 2021-08-19Updated: 2021-08-25

Phase 2

Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
CompletedNCT03248882
PfizerNonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Start: 2017-08-22End: 2019-03-27Updated: 2020-12-09
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
CompletedNCT04321031
PfizerNonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Start: 2020-06-15End: 2024-02-21Updated: 2025-03-21
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
CompletedNCT04399538
PfizerNonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Start: 2020-08-10End: 2022-04-28Updated: 2023-04-13

Related Papers

Efficacy and safety of ervogastat alone and in combination with clesacostat in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and F2-F3 fibrosis (MIRNA): results from a phase 2, randomised, double-blind, double-dummy study.
2025-07-313 citations
SomaLogic proteomics reveals new biomarkers and provides mechanistic, clinical insights into Acetyl coA Carboxylase (ACC) inhibition in Non-alcoholic Steatohepatitis (NASH).
2024-07-245 citations
Efficacy and safety of an orally administered DGAT2 inhibitor alone or coadministered with a liver-targeted ACC inhibitor in adults with non-alcoholic steatohepatitis (NASH): rationale and design of the phase II, dose-ranging, dose-finding, randomised, placebo-controlled MIRNA (Metabolic Interventions to Resolve NASH with fibrosis) study
BMJ Open2022-03-0149 citations
ACC inhibitor alone or co-administered with a DGAT2 inhibitor in patients with non-alcoholic fatty liver disease: two parallel, placebo-controlled, randomized phase 2a trials.
2021-10-11165 citations