NCT03844555 is a Phase 1 clinical trial of Elafibranor in Renal Impairment, sponsored by Genfit.

Who is sponsoring NCT03844555?

NCT03844555 is sponsored by Genfit.

What drugs are being tested in NCT03844555?

Interventions in NCT03844555: Elafibranor.

What condition does NCT03844555 study?

NCT03844555 studies Renal Impairment, Renal Insufficiency, Kidney Diseases, Pharmacokinetics.

Is NCT03844555 still recruiting?

NCT03844555 is currently completed. Last updated 13 August 2020.

Last reviewed 2020-08-13 · How we verify

NCT03844555

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

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Completed Phase 1 Last updated 13 August 2020

What this trial tests

Phase 1 trial testing Elafibranor in Renal Impairment in 23 participants. Completed in 21 March 2020.

Timeline

28 February 2019

Primary endpoint
15 March 2020

21 March 2020

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	23
Start date	28 February 2019
Primary completion	15 March 2020
Estimated completion	21 March 2020
Sites	2 locations across France, Romania

Drugs / interventions tested

Elafibranor (ELAFIBRANOR) — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →
Renal Insufficiency — all drugs for Renal Insufficiency →
Kidney Diseases — all drugs for Kidney Diseases →
Pharmacokinetics — all drugs for Pharmacokinetics →

Sponsor

Genfit — full company profile →

Who can join

Adults 18 to 75, any sex, with Renal Impairment or Renal Insufficiency. 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 participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR\<15mL/mn/1.73m\^2) versus healthy participants after a single oral administration of elafibranor 120 mg

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Common Drug Pipelines for the Treatment of Diabetic Nephropathy and Hepatopathy: Can We Kill Two Birds with One Stone?
Sumida Y, Yoneda M, Toyoda H, Yasuda S, et al · · 2020 · cited 10× · PMID 32668632 · DOI 10.3390/ijms21144939
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 Renal Impairment

Currently open trials in the same condition.

NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · 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 NCT03844555 (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: 13 August 2020

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/NCT03844555.

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