Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Terminated
Genfit
Phase 3
The primary objectives of this study are to evaluate the effect of Elafibranor treatment
compared to placebo on 1) histological improvement and 2) all-cause mortality and
liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Completed
Genfit
Phase 2
The primary objective of the study is to compare the effect of daily oral administration of
elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo
in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
Completed
Syneos Health
Phase 1
This study is being conducted in order to assess the need for dose adjustment for elafibranor
in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active
metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe
according to Child-Pugh categories) versus healthy participants after a single oral
administration of elafibranor 120 mg.
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
Completed
University of Miami
Phase 1
This study is being conducted in order to assess the need for dose adjustment for elafibranor
in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active
metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe
according to Child-Pugh categories) versus healthy participants after a single oral
administration of elafibranor 120 mg.
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