NCT03883607 is a Phase 2 clinical trial of Elafibranor 80mg in Non Alcoholic Steatohepatitis, sponsored by Genfit.

Who is sponsoring NCT03883607?

NCT03883607 is sponsored by Genfit.

What drugs are being tested in NCT03883607?

Interventions in NCT03883607: Elafibranor 80mg, Elafibranor 120mg.

What condition does NCT03883607 study?

NCT03883607 studies Non Alcoholic Steatohepatitis.

Is NCT03883607 still recruiting?

NCT03883607 is currently terminated. Last updated 28 October 2021.

Are results published for NCT03883607?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-28 · How we verify

NCT03883607

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

Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)

Terminated Phase 2 Results posted Last updated 28 October 2021

What this trial tests

Phase 2 trial testing Elafibranor 80mg in Non Alcoholic Steatohepatitis in 10 participants. Terminated before completion.

Timeline

25 June 2019

Primary endpoint
16 June 2020

16 June 2020

Quick facts

Lead sponsor	Genfit
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	25 June 2019
Primary completion	16 June 2020
Estimated completion	16 June 2020
Sites	2 locations across United States

Drugs / interventions tested

Elafibranor 80mg — full drug profile →
Elafibranor 120mg — full drug profile →

Conditions studied

Non Alcoholic Steatohepatitis — all drugs for Non Alcoholic Steatohepatitis →

Sponsor

Genfit — full company profile →

Who can join

Adults 8 to 17, any sex, with Non Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Elafibranor and Its Active Metabolite (GFT1007) Primary · Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administration

Cmax was defined as maximum observed plasma concentration.

Elafibranor

Group	Value	95% CI
Elafibranor 80 mg	385.216	± 218.646
Elafibranor 120 mg	658.054	± 403.201

GFT1007

Group	Value	95% CI
Elafibranor 80 mg	2367.620	± 1088.123
Elafibranor 120 mg	2875.280	± 1443.324

Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of Elafibranor and Active Metabolite (GFT1007) Primary · Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administration

Tmax was defined as time to reach maximum observed plasma concentration.

Elafibranor

Group	Value	95% CI
Elafibranor 80 mg	1.50	0.52 – 2.00
Elafibranor 120 mg	1.00	0.98 – 1.50

GFT1007

Group	Value	95% CI
Elafibranor 80 mg	2.00	1.50 – 2.00
Elafibranor 120 mg	1.50	1.00 – 1.50

Pharmacokinetics: Area Under The Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Elafibranor and Active Metabolite (GFT1007) Primary · Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administration

AUC0-24 defined as the area under the plasma concentration versus time curve of the study drug from time 0 to 24 hours.

Elafibranor

Group	Value	95% CI
Elafibranor 80 mg	973.301	± 311.803
Elafibranor 120 mg	1457.728	± 724.018

GFT1007

Group	Value	95% CI
Elafibranor 80 mg	10011.405	± 3575.220
Elafibranor 120 mg	10532.930	± 3257.220

Pharmacokinetics: Terminal Elimination Half-life ( t½) of Elafibranor and Active Metabolite (GFT1007) Primary · Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administration

Plasma t1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration.

Elafibranor

Group	Value	95% CI
Elafibranor 80 mg	34.170	± NA
Elafibranor 120 mg	37.620	± 15.473

GFT1007

Group	Value	95% CI
Elafibranor 80 mg	9.572	± 5.592
Elafibranor 120 mg	6.682	± 1.120

Pharmacokinetics: Plasma Trough Concentrations (Ctrough) of Elafibranor and Active Metabolite (GFT1007) Primary · Pre-dose on Day 1 and 29

Ctrough was defined as the plasma concentration of study drug observed just before treatment administration during repeated dosing.

Elafibranor

Group	Value	95% CI
Elafibranor 80 mg	14.904	± 3.516
Elafibranor 120 mg	29.035	± 15.087

GFT1007

Group	Value	95% CI
Elafibranor 80 mg	97.771	± 49.636
Elafibranor 120 mg	55.243	± 27.769

Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 15, 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis. Normal range at screening: AST: 0 - 39 international units per liter (IU/L), ALT: 5 - 30 IU/L, GGT: 2 - 24 IU/L, and ALP: 74 - 390 IU/L.

ALT: Day 15

Group	Value	95% CI
Elafibranor 80 mg	4.2	± 21.7
Elafibranor 120 mg	-13.8	± 25.0

ALT: Day 29

Group	Value	95% CI
Elafibranor 80 mg	-0.2	± 35.9
Elafibranor 120 mg	-27.6	± 18.4

ALT: Day 57

Group	Value	95% CI
Elafibranor 80 mg	0.2	± 27.3
Elafibranor 120 mg	-30.8	± 16.5

ALT: Day 85

Group	Value	95% CI
Elafibranor 80 mg	17.8	± 56.6
Elafibranor 120 mg	-34.6	± 25.6

ALT: Day 113

Group	Value	95% CI
Elafibranor 80 mg	37.3	± 46.9
Elafibranor 120 mg	-28.0	± 22.2

AST: Day 15

Group	Value	95% CI
Elafibranor 80 mg	4.0	± 16.0
Elafibranor 120 mg	0.8	± 9.5

AST: Day 29

Group	Value	95% CI
Elafibranor 80 mg	4.0	± 16.3
Elafibranor 120 mg	-4.0	± 9.5

AST: Day 57

Group	Value	95% CI
Elafibranor 80 mg	1.0	± 6.1
Elafibranor 120 mg	-5.8	± 4.1

Pharmacodynamics - Other Liver Markers: Change From Baseline in Adiponectin at Days 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Day 29

Group	Value	95% CI
Elafibranor 80 mg	0.2410	± 0.3729
Elafibranor 120 mg	0.2112	± 1.0304

Day 57

Group	Value	95% CI
Elafibranor 80 mg	0.5780	± 1.0530
Elafibranor 120 mg	-0.2752	± 1.0022

Day 85

Group	Value	95% CI
Elafibranor 80 mg	0.3372	± 1.4844
Elafibranor 120 mg	-0.0590	± 1.0476

Day 113

Group	Value	95% CI
Elafibranor 80 mg	-0.4663	± 0.8972
Elafibranor 120 mg	0.0322	± 1.0588

Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

CK-18/M65: Day 29

Group	Value	95% CI
Elafibranor 80 mg	39.412	± 346.370
Elafibranor 120 mg	-70.902	± 121.905

CK-18/M65: Day 57

Group	Value	95% CI
Elafibranor 80 mg	-30.302	± 326.632
Elafibranor 120 mg	-60.578	± 186.165

CK-18/M65: Day 85

Group	Value	95% CI
Elafibranor 80 mg	-2.320	± 231.775
Elafibranor 120 mg	-122.070	± 265.059

CK-18/M65: Day 113

Group	Value	95% CI
Elafibranor 80 mg	235.205	± 290.846
Elafibranor 120 mg	-188.638	± 244.324

CK-18/M30: Day 29

Group	Value	95% CI
Elafibranor 80 mg	-24.282	± 374.146
Elafibranor 120 mg	-68.896	± 96.850

CK-18/M30: Day 57

Group	Value	95% CI
Elafibranor 80 mg	7.530	± 445.509
Elafibranor 120 mg	-20.074	± 219.782

CK-18/M30: Day 85

Group	Value	95% CI
Elafibranor 80 mg	-54.988	± 315.261
Elafibranor 120 mg	-81.492	± 271.506

CK-18/M30: Day 113

Group	Value	95% CI
Elafibranor 80 mg	146.412	± 273.673
Elafibranor 120 mg	-170.793	± 235.722

Pharmacodynamics - Other Liver Markers: Change From Baseline in Ferritin at Days 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Day 29

Group	Value	95% CI
Elafibranor 80 mg	6.4	± 12.0
Elafibranor 120 mg	10.8	± 25.9

Day 57

Group	Value	95% CI
Elafibranor 80 mg	19.4	± 23.5
Elafibranor 120 mg	3.6	± 15.6

Day 85

Group	Value	95% CI
Elafibranor 80 mg	11.8	± 16.6
Elafibranor 120 mg	-4.0	± 2.4

Day 113

Group	Value	95% CI
Elafibranor 80 mg	6.0	± 5.7
Elafibranor 120 mg	-12.8	± 11.1

Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Fibroblast Growth Factor 19: Day 29

Group	Value	95% CI
Elafibranor 80 mg	-24.4	± 80.6
Elafibranor 120 mg	-42.8	± 78.0

Fibroblast Growth Factor 19: Day 57

Group	Value	95% CI
Elafibranor 80 mg	-10.4	± 51.2
Elafibranor 120 mg	-18.8	± 85.3

Fibroblast Growth Factor 19: Day 85

Group	Value	95% CI
Elafibranor 80 mg	28.4	± 77.5
Elafibranor 120 mg	-13.0	± 100.6

Fibroblast Growth Factor 19: Day 113

Group	Value	95% CI
Elafibranor 80 mg	-7.8	± 61.3
Elafibranor 120 mg	-19.8	± 35.3

Fibroblast Growth Factor 21: Day 29

Group	Value	95% CI
Elafibranor 80 mg	9.98	± 91.38
Elafibranor 120 mg	128.84	± 171.50

Fibroblast Growth Factor 21: Day 57

Group	Value	95% CI
Elafibranor 80 mg	-36.36	± 188.91
Elafibranor 120 mg	195.94	± 315.73

Fibroblast Growth Factor 21: Day 85

Group	Value	95% CI
Elafibranor 80 mg	120.68	± 191.62
Elafibranor 120 mg	81.56	± 130.68

Fibroblast Growth Factor 21: Day 113

Group	Value	95% CI
Elafibranor 80 mg	3.50	± 291.41
Elafibranor 120 mg	56.35	± 87.53

Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Hyaluronic Acid: Day 29

Group	Value	95% CI
Elafibranor 80 mg	-2.958	± 11.689
Elafibranor 120 mg	-8.800	± 10.991

Hyaluronic Acid: Day 57

Group	Value	95% CI
Elafibranor 80 mg	-0.272	± 9.228
Elafibranor 120 mg	-3.654	± 10.528

Hyaluronic Acid: Day 85

Group	Value	95% CI
Elafibranor 80 mg	4.408	± 16.612
Elafibranor 120 mg	-3.518	± 15.130

Hyaluronic Acid: Day 113

Group	Value	95% CI
Elafibranor 80 mg	1.592	± 16.445
Elafibranor 120 mg	-0.422	± 19.347

Procollagen 3 N-Terminal Propeptide: Day 29

Group	Value	95% CI
Elafibranor 80 mg	-3.018	± 14.079
Elafibranor 120 mg	-2.878	± 3.138

Procollagen 3 N-Terminal Propeptide: Day 57

Group	Value	95% CI
Elafibranor 80 mg	1.730	± 6.928
Elafibranor 120 mg	-2.762	± 3.242

Procollagen 3 N-Terminal Propeptide: Day 85

Group	Value	95% CI
Elafibranor 80 mg	-1.710	± 6.730
Elafibranor 120 mg	-0.470	± 5.270

Procollagen 3 N-Terminal Propeptide: Day 113

Group	Value	95% CI
Elafibranor 80 mg	-7.015	± 11.902
Elafibranor 120 mg	-0.530	± 3.701

Pharmacodynamics - Other Liver Markers: Change From Baseline in Alpha-2 Macroglobulin at Days 29, 57, 85, and 113 Secondary · Baseline (Day 1), Days 29, 57, 85, and 113

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Day 29

Group	Value	95% CI
Elafibranor 80 mg	-0.098	± 0.254
Elafibranor 120 mg	-0.282	± 0.133

Day 57

Group	Value	95% CI
Elafibranor 80 mg	0.124	± 0.213
Elafibranor 120 mg	-0.118	± 0.064

Day 85

Group	Value	95% CI
Elafibranor 80 mg	-0.030	± 0.328
Elafibranor 120 mg	-0.204	± 0.129

Day 113

Group	Value	95% CI
Elafibranor 80 mg	-0.105	± 0.319
Elafibranor 120 mg	-0.037	± 0.157

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Elafibranor 80 mg

Serious: 0/5 (0%)

Deaths: 0/5

Elafibranor 120 mg

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (3 terms — click to expand)

Reaction	System	Elafibranor 80 mg	Elafibranor 120 mg
Hepatomegaly	Hepatobiliary disorders	—	—
Gastroenteritis viral	Infections and infestations	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03883607 adverse events section.

Sponsor's own description

The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams \[mg\] and 120mg) during 3 months in children and adolescent population (8 to 17 years of age) with non alcoholic steatohepatitis (NASH).

Publications & conference data

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

Transcriptional Regulation of Metabolic Pathways via Lipid-Sensing Nuclear Receptors PPARs, FXR, and LXR in NASH.
Cariello M, Piccinin E, Moschetta A. · · 2021 · cited 71× · PMID 33545430 · DOI 10.1016/j.jcmgh.2021.01.012
Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease.
Kamata S, Honda A, Ishii I. · · 2023 · cited 42× · PMID 37627329 · DOI 10.3390/biom13081264
Metabolic Fatty Liver Disease in Children: A Growing Public Health Problem.
Le Garf S, Nègre V, Anty R, Gual P. · · 2021 · cited 39× · PMID 34944730 · DOI 10.3390/biomedicines9121915
Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.
Vitulo M, Gnodi E, Rosini G, Meneveri R, et al · · 2023 · cited 21× · PMID 37628929 · DOI 10.3390/ijms241612748
Recent advances in understanding and managing pediatric nonalcoholic fatty liver disease.
Vittorio J, Lavine JE. · · 2020 · cited 18× · PMID 32509277 · DOI 10.12688/f1000research.24198.1
Potential therapeutic strategies for MASH: from preclinical to clinical development.
Xie Z, Li Y, Cheng L, Huang Y, et al · · 2024 · cited 11× · PMID 39872142 · DOI 10.1093/lifemeta/loae029
An Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis.
Goyal NP, Mencin A, Newton KP, Durelle J, et al · · 2023 · cited 10× · PMID 37084342 · DOI 10.1097/mpg.0000000000003796
Metabolic-Associated Steatotic Liver Disease (MASLD): A New Term for a More Appropriate Therapy in Pediatrics?
Antonella M, Pietrobattista A, Maggiore G. · · 2024 · cited 6× · PMID 38651464 · DOI 10.3390/pediatric16020025

Verify or expand the search:

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Other Genfit trials

Trials by the same sponsor.

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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 NCT03883607 (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: 28 October 2021

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/NCT03883607.

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

NCT03883607

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Elafibranor 80mg

Other recruiting trials for Non Alcoholic Steatohepatitis

Other Genfit trials

Verify against primary sources