Elafibranor Clinical Trials (2026): 16 Studies for Pharmacokinetics & Primary Sclerosing Cholangitis

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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16 Elafibranor clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 13 indications (including Pharmacokinetics & Primary Sclerosing Cholangitis) and 3,353 total planned enrollment. 6 Phase 3 Elafibranor trials and 4 Phase 2 are listed. 2 Elafibranor clinical trials are actively recruiting at 29 U.S. sites across 13 states. Most recent activity: NCT06730061 (Apr 2032).

Where to Participate: All Elafibranor Trial Sites in the U.S. (29 sites across 13 states)

Every actively recruiting Elafibranortrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
AZArizona Liver HealthChandler85224NCT07387549Map
AZArizona Liver HealthTucson85641NCT06016842Map
CASouthern California Research CenterCoronado92118NCT06016842Map
CAGastroIntestinal BioSciencesLos Angeles90067NCT06016842Map
CAUniversity of California Davis Medical CenterSacramento95817NCT06016842Map
COUniversity of ColoradoAurora80045NCT06016842Map
COPeak Gastroenterology AssociatesColorado Springs80829NCT06016842Map
COSouth Denver Gastroenterology, P.C.Englewood80113NCT06016842Map
CORocky Mountain GastroenterologyLittleton80120NCT06016842Map
FLUniversity Of Miami School Of Medicine, Center For Liver DiseasesMiami33136NCT06016842Map
FLBolanos Clinical ResearchPembroke Pines12105NCT06016842Map
FLInternational Center for ResearchTampa33614NCT06016842Map
LALouisiana Research Center, LLCShreveport71103NCT06016842Map
MIUniversity of Michigan Health SystemAnn Arbor48109NCT06016842Map
NYNYU Langone Gastroenterology and Hepatology AssociatesNew York10016NCT06016842Map
PAUniversity of PittsburghPittsburgh15213NCT06016842Map
SCMedical University of South CarolinaCharleston29425NCT06016842Map
TNGastroenterology Center of the MidsouthCordova38138NCT06016842Map
TXTexas Clinical Research InstituteArlington22201NCT06016842Map
TXAmerican Research CorporationAustin78757NCT06016842Map
TXMethodist Transplant PhysiciansDallas75203NCT06016842Map
TXUniversity of Texas Southwestern Medical Center at DallasDallas75390NCT06016842Map
TXHouston Methodist Cancer CenterHouston77584NCT06016842Map
TXLiver Associates of TexasHouston77030NCT06016842Map
TXAmerican Research Corporation at The Texas Liver InstituteSan Antonio78015NCT06016842Map
TXAmerican Research Corporation at The Texas Liver InstituteSan Antonio78215NCT07387549Map
VAUniversity of Virginia Medical CenterCharlottesville22903NCT06016842Map
VABon Secours St. Mary's Hospital of Richmond, IncRichmond23226NCT06016842Map
WAVelocity Clinical Research at Liver Institute NorthwestSeattle98105NCT06016842Map

Elafibranor clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedterminatedTotal
P166
P21124
P32316

Recruiting Elafibranor clinical trials (2)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07387549ELASCOPEA Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing CholangitisP3Primary Sclerosing Cholangitis350May 2026
NCT06016842ELFIDENCEA Long-Term Study of Elafibranor in Adult Participants With Primary Biliary CholangitisP3Primary Biliary Cholangitis (PBC)276Aug 2023

Elafibranor clinical trials by indication

Primary Sclerosing Cholangitis (2)

NCTAcronymPhaseStatusTitle
NCT05627362ELMWOODP2active not recruitingA Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
NCT07387549ELASCOPEP3recruitingA Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis

Primary Biliary Cholangitis (2)

NCTAcronymPhaseStatusTitle
NCT06730061ELONSENP3active not recruitingA Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
NCT06383403ELSPIREP3active not recruitingA Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Primary Biliary Cholangitis (PBC) (2)

NCTAcronymPhaseStatusTitle
NCT06016842ELFIDENCEP3recruitingA Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
NCT03124108PBCP2completedStudy to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Healthy Participants (1)

NCTAcronymPhaseStatusTitle
NCT05564208P1completedA Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet

Healthy Volunteers (1)

NCTAcronymPhaseStatusTitle
NCT05543369P1completedStudy to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

Primary Biliary Cirrhosis (1)

NCTAcronymPhaseStatusTitle
NCT04526665ELATIVEP3active not recruitingStudy of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

Geriatrics (1)

NCTAcronymPhaseStatusTitle
NCT04171752P1completedElafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

Drug-drug Interaction (1)

NCTAcronymPhaseStatusTitle
NCT03985969P1completedStudy to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin

Non-Alcoholic Fatty Liver (1)

NCTAcronymPhaseStatusTitle
NCT03953456NAFLP2terminatedStudy to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

Non Alcoholic Steatohepatitis (1)

NCTAcronymPhaseStatusTitle
NCT03883607NASHP2terminatedElafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)

Renal Impairment (1)

NCTAcronymPhaseStatusTitle
NCT03844555P1completedElafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Hepatic Impairment (1)

NCTAcronymPhaseStatusTitle
NCT03765671P1completedElafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

Nonalcoholic Steatohepatitis (NASH) With Fibrosis (1)

NCTAcronymPhaseStatusTitle
NCT02704403RESOLVE-ITP3terminatedPhase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

Elafibranor pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
ELONSENNCT06730061P3active not recruitingPrimary Biliary Cholangitis18
ELASCOPENCT07387549P3recruitingPrimary Sclerosing Cholangitis350
ELFIDENCENCT06016842P3recruitingPrimary Biliary Cholangitis (PBC)276
ELATIVENCT04526665P3active not recruitingPrimary Biliary Cirrhosis161PMID 41937506
ELSPIRENCT06383403P3active not recruitingPrimary Biliary Cholangitis69
RESOLVE-ITNCT02704403P3terminatedNonalcoholic Steatohepatitis (NASH) With Fibrosis2,157
ELMWOODNCT05627362P2active not recruitingPrimary Sclerosing Cholangitis68PMID 40350321
NAFLNCT03953456P2terminatedNon-Alcoholic Fatty Liver17
NASHNCT03883607P2terminatedNon Alcoholic Steatohepatitis10PMID 37084342
PBCNCT03124108P2completedPrimary Biliary Cholangitis (PBC)45PMID 33484775

Terminated and withdrawn Elafibranor trials (3)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

All Elafibranor trials (16)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06730061ELONSENA Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)P3active not recruiting18IpsenJan 2025
NCT05627362ELMWOODA Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.P2active not recruiting68IpsenDec 2022
NCT07387549ELASCOPEA Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing CholangitisP3recruiting350IpsenMay 2026
NCT06016842ELFIDENCEA Long-Term Study of Elafibranor in Adult Participants With Primary Biliary CholangitisP3recruiting276IpsenAug 2023
NCT04526665ELATIVEStudy of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)P3active not recruiting161IpsenSep 2020
NCT06383403ELSPIREA Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.P3active not recruiting69IpsenJul 2024
NCT05543369Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy ParticipantsP1completed48IpsenSep 2022
NCT05564208A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single TabletP1completed34IpsenOct 2022
NCT02704403RESOLVE-ITPhase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)P3terminated2,157GenfitMar 2016
NCT03953456NAFLStudy to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)P2terminated17GenfitAug 2019
NCT03883607NASHElafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)P2terminated10GenfitJun 2019
NCT03985969Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and IndomethacinP1completed26GenfitSep 2019
NCT04171752Elafibranor Pharmacokinetic Parameters in Elderly Healthy VolunteersP1completed21GenfitNov 2019
NCT03844555Elafibranor Pharmacokinetic Parameters in Renal Impaired PatientsP1completed23GenfitFeb 2019
NCT03765671Elafibranor Pharmacokinetic Parameters in Hepatic Impaired PatientsP1completed30GenfitDec 2018
NCT03124108PBCStudy to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic AcidP2completed45GenfitApr 2017

Elafibranor clinical trials: frequently asked questions

How many Elafibranor clinical trials are there?
16 Elafibranor clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 2 are actively recruiting participants. 7 are marked completed.
Are Elafibranor clinical trials recruiting in 2026?
Yes — 2 Elafibranor trials are actively recruiting in 2026, with 29 U.S. sites across 13 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Elafibranor being studied for?
Elafibranor is being studied for Pharmacokinetics, Primary Sclerosing Cholangitis, Primary Biliary Cholangitis, Primary Biliary Cholangitis (PBC), Healthy Volunteers and 13 more. The trials are grouped by indication on this page.
What phase is Elafibranor in?
Elafibranor clinical trials span 6 Phase 3, 4 Phase 2, 6 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Elafibranor clinical trials?
The lead sponsor across the most Elafibranor trials is Genfit, with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Elafibranoras an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

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