CLINICAL TRIALS PROFILE FOR ELAFIBRANOR

All Clinical Trials for ELAFIBRANOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02704403 ↗	Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)	Terminated	Genfit	Phase 3	2016-03-01	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.
NCT03124108 ↗	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	2017-04-05	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).
NCT03765671 ↗	Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients	Completed	Syneos Health	Phase 1	2018-12-12	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.
NCT03765671 ↗	Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients	Completed	University of Miami	Phase 1	2018-12-12	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.
NCT03765671 ↗	Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients	Completed	Genfit	Phase 1	2018-12-12	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.

Clinical Trial Conditions for ELAFIBRANOR

Condition Name

Condition Name for ELAFIBRANOR
Intervention	Trials
Pharmacokinetics	2
Primary Biliary Cholangitis (PBC)	2
Primary Biliary Cirrhosis	1
Healthy Participants	1

Condition MeSH

Condition MeSH for ELAFIBRANOR
Intervention	Trials
Cholangitis	4
Non-alcoholic Fatty Liver Disease	3
Fatty Liver	3
Liver Cirrhosis, Biliary	3

Clinical Trial Locations for ELAFIBRANOR

Trials by Country

Trials by Country for ELAFIBRANOR
Location	Trials
United States	70
Canada	6
France	6
United Kingdom	4
Spain	4

Trials by US State

Trials by US State for ELAFIBRANOR
Location	Trials
Florida	4
California	4
Arizona	4
Texas	4
New York	4

Clinical Trial Progress for ELAFIBRANOR

Clinical Trial Phase

Clinical Trial Phase for ELAFIBRANOR
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1	6

Clinical Trial Status

Clinical Trial Status for ELAFIBRANOR
Clinical Trial Phase	Trials
Completed	5
Terminated	3
Not yet recruiting	3

Clinical Trial Sponsors for ELAFIBRANOR

Sponsor Name

Sponsor Name for ELAFIBRANOR
Sponsor	Trials
Genfit	9
Ipsen	4
Syneos Health	1

Sponsor Type

Sponsor Type for ELAFIBRANOR
Sponsor	Trials
Industry	13
Other	2