NCT03765671 is a Phase 1 clinical trial of Elafibranor in Hepatic Impairment, sponsored by Genfit.

Who is sponsoring NCT03765671?

NCT03765671 is sponsored by Genfit.

What drugs are being tested in NCT03765671?

Interventions in NCT03765671: Elafibranor.

What condition does NCT03765671 study?

NCT03765671 studies Hepatic Impairment, Liver Disease, Pharmacokinetics.

Is NCT03765671 still recruiting?

NCT03765671 is currently completed. Last updated 22 August 2019.

Last reviewed 2019-08-22 · How we verify

NCT03765671

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

Completed Phase 1 Last updated 22 August 2019

What this trial tests

Phase 1 trial testing Elafibranor in Hepatic Impairment in 30 participants. Completed in 14 June 2019.

Timeline

12 December 2018

Primary endpoint
7 June 2019

14 June 2019

Quick facts

Lead sponsor	Genfit
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	12 December 2018
Primary completion	7 June 2019
Estimated completion	14 June 2019
Sites	2 locations across United States

Drugs / interventions tested

Elafibranor (ELAFIBRANOR) — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →
Liver Disease — all drugs for Liver Disease →
Pharmacokinetics — all drugs for Pharmacokinetics →

Sponsor

Genfit — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment or Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Lipid metabolism in homeostasis and disease.
Li Z, Deng W, Yang L, Tang C, et al · · 2026 · cited 2× · PMID 41692800 · DOI 10.1038/s41392-025-02357-x

Verify or expand the search:

Other trials of Elafibranor

Trials testing the same drug.

NCT07387549 — A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis · Phase 3 · not yet recruiting
NCT06730061 — A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) · Phase 3 · active not recruiting
NCT06383403 — A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycho · Phase 3 · active not recruiting
NCT06016842 — A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
NCT05543369 — Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Partici · Phase 1 · completed

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Genfit trials

Trials by the same sponsor.

NCT07110441 — Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers · Phase 1 · completed
NCT06987968 — A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With · Phase 2 · terminated
NCT05900050 — Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT) · Phase 2 · terminated
NCT05368935 — Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects · Phase 1 · completed
NCT05116826 — Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03765671 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genfit
Last refreshed: 22 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03765671.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing