Elafibranor Clinical Trials (2026): 16 Studies for Pharmacokinetics & Primary Sclerosing Cholangitis
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
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 3,376 total planned enrollment. 6 Phase 3 Elafibranor trials and 4 Phase 2 are listed. 2 Elafibranor clinical trials are actively recruiting at 33 U.S. sites across 15 states. Most recent activity: NCT06730061 (Apr 2032).
Where to Participate: All Elafibranor Trial Sites in the U.S. (33 sites across 15 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.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AZ | Arizona Liver Health | Chandler85224 | NCT07387549 | Map |
| AZ | Arizona Liver Health | Tucson85641 | NCT06016842 | Map |
| CA | Southern California Research Center | Coronado92118 | NCT06016842 | Map |
| CA | GastroIntestinal BioSciences | Los Angeles90067 | NCT06016842 | Map |
| CA | University of California Davis Medical Center | Sacramento95817 | NCT06016842 | Map |
| CO | University of Colorado | Aurora80045 | NCT06016842 | Map |
| CO | Peak Gastroenterology Associates | Colorado Springs80829 | NCT06016842 | Map |
| CO | Peak Gastroenterology Associates | Colorado Springs80920 | NCT07387549 | Map |
| CO | South Denver Gastroenterology, P.C. | Englewood80113 | NCT06016842 | Map |
| CO | Rocky Mountain Gastroenterology | Littleton80120 | NCT06016842 | Map |
| FL | University Of Miami School Of Medicine, Center For Liver Diseases | Miami33136 | NCT06016842 | Map |
| FL | Bolanos Clinical Research | Pembroke Pines12105 | NCT06016842 | Map |
| FL | International Center for Research | Tampa33614 | NCT06016842 | Map |
| LA | Louisiana Research Center, LLC | Shreveport71103 | NCT06016842 | Map |
| MI | University of Michigan Health System | Ann Arbor48109 | NCT06016842 | Map |
| MN | Mayo Clinic | Rochester55905 | NCT06016842 | Map |
| NY | NYU Langone Gastroenterology and Hepatology Associates | New York10016 | NCT06016842 | Map |
| PA | University of Pittsburgh | Pittsburgh15213 | NCT06016842 | Map |
| SC | Medical University of South Carolina | Charleston29425 | NCT06016842 | Map |
| TN | Gastroenterology Center of the Midsouth | Cordova38138 | NCT06016842 | Map |
| TN | Gastrointestinal Associates of Northeast Tennessee | Johnson City37604 | NCT07387549 | Map |
| TX | Texas Clinical Research Institute | Arlington22201 | NCT06016842 | Map |
| TX | American Research Corporation | Austin78757 | NCT06016842 | Map |
| TX | Methodist Transplant Physicians | Dallas75203 | NCT06016842 | Map |
| TX | University of Texas Southwestern Medical Center at Dallas | Dallas75390 | NCT06016842 | Map |
| TX | Houston Methodist Cancer Center | Houston77584 | NCT06016842 | Map |
| TX | Liver Associates of Texas | Houston77030 | NCT06016842 | Map |
| TX | American Research Corporation at The Texas Liver Institute | San Antonio78015 | NCT06016842 | Map |
| TX | American Research Corporation at The Texas Liver Institute | San Antonio78215 | NCT07387549 | Map |
| VA | University of Virginia Medical Center | Charlottesville22903 | NCT06016842 | Map |
| VA | Bon Secours St. Mary's Hospital of Richmond, Inc | Richmond23226 | NCT06016842 | Map |
| WA | Velocity Clinical Research at Liver Institute Northwest | Seattle98105 | NCT06016842 | Map |
| WV | University Physicians and Surgeons Inc, dba Marshall Health | Huntington25701 | NCT06016842 | Map |
Elafibranor clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | Total |
|---|---|---|---|---|---|
| P1 | 6 | 6 | |||
| P2 | 1 | 1 | 2 | 4 | |
| P3 | 2 | 2 | 1 | 1 | 6 |
Recruiting Elafibranor clinical trials (2)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07387549 | ELASCOPEA Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis | P3 | Primary Sclerosing Cholangitis | 350 | May 2026 |
| NCT06016842 | ELFIDENCEA Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis | P3 | Primary Biliary Cholangitis (PBC) | 276 | Aug 2023 |
Elafibranor clinical trials by indication
Primary Sclerosing Cholangitis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05627362 | ELMWOOD | P2 | active not recruiting | A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. |
| NCT07387549 | ELASCOPE | P3 | recruiting | A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis |
Primary Biliary Cholangitis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06730061 | ELONSEN | P3 | active not recruiting | A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) |
| NCT06383403 | ELSPIRE | P3 | completed | A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. |
Primary Biliary Cholangitis (PBC) (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06016842 | ELFIDENCE | P3 | recruiting | A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis |
| NCT03124108 | PBC | P2 | completed | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid |
Healthy Participants (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05564208 | — | P1 | completed | A 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05543369 | — | P1 | completed | Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants |
Primary Biliary Cirrhosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04526665 | ELATIVE | P3 | active not recruiting | Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) |
Geriatrics (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04171752 | — | P1 | completed | Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers |
Drug-drug Interaction (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03985969 | — | P1 | completed | Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin |
Non-Alcoholic Fatty Liver (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03953456 | NAFL | P2 | terminated | Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL) |
Non Alcoholic Steatohepatitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03883607 | NASH | P2 | terminated | Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) |
Renal Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03844555 | — | P1 | completed | Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients |
Hepatic Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03765671 | — | P1 | completed | Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients |
Nonalcoholic Steatohepatitis (NASH) With Fibrosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02704403 | RESOLVE-IT | P3 | terminated | Phase 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.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ELONSEN | NCT06730061 | P3 | active not recruiting | Primary Biliary Cholangitis | 18 | — |
| ELASCOPE | NCT07387549 | P3 | recruiting | Primary Sclerosing Cholangitis | 350 | — |
| ELFIDENCE | NCT06016842 | P3 | recruiting | Primary Biliary Cholangitis (PBC) | 276 | — |
| ELATIVE | NCT04526665 | P3 | active not recruiting | Primary Biliary Cirrhosis | 161 | PMID 41937506 |
| ELSPIRE | NCT06383403 | P3 | completed | Primary Biliary Cholangitis | 92 | — |
| RESOLVE-IT | NCT02704403 | P3 | terminated | Nonalcoholic Steatohepatitis (NASH) With Fibrosis | 2,157 | — |
| ELMWOOD | NCT05627362 | P2 | active not recruiting | Primary Sclerosing Cholangitis | 68 | PMID 40350321 |
| NAFL | NCT03953456 | P2 | terminated | Non-Alcoholic Fatty Liver | 17 | — |
| NASH | NCT03883607 | P2 | terminated | Non Alcoholic Steatohepatitis | 10 | PMID 37084342 |
| PBC | NCT03124108 | P2 | completed | Primary Biliary Cholangitis (PBC) | 45 | PMID 33484775 |
Terminated and withdrawn Elafibranor trials (3)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT02704403terminatedPhase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT03953456terminatedStudy to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
- NCT03883607terminatedElafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
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 ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06730061 | ELONSEN | A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) | P3 | active not recruiting | 18 | Ipsen | Jan 2025 |
| NCT05627362 | ELMWOOD | A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. | P2 | active not recruiting | 68 | Ipsen | Dec 2022 |
| NCT07387549 | ELASCOPE | A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis | P3 | recruiting | 350 | Ipsen | May 2026 |
| NCT06016842 | ELFIDENCE | A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis | P3 | recruiting | 276 | Ipsen | Aug 2023 |
| NCT04526665 | ELATIVE | Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) | P3 | active not recruiting | 161 | Ipsen | Sep 2020 |
| NCT06383403 | ELSPIRE | A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. | P3 | completed | 92 | Ipsen | Jul 2024 |
| NCT05543369 | Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants | P1 | completed | 48 | Ipsen | Sep 2022 | |
| NCT05564208 | A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet | P1 | completed | 34 | Ipsen | Oct 2022 | |
| NCT02704403 | RESOLVE-IT | Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) | P3 | terminated | 2,157 | Genfit | Mar 2016 |
| NCT03953456 | NAFL | Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL) | P2 | terminated | 17 | Genfit | Aug 2019 |
| NCT03883607 | NASH | Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) | P2 | terminated | 10 | Genfit | Jun 2019 |
| NCT03985969 | Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin | P1 | completed | 26 | Genfit | Sep 2019 | |
| NCT04171752 | Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers | P1 | completed | 21 | Genfit | Nov 2019 | |
| NCT03844555 | Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients | P1 | completed | 23 | Genfit | Feb 2019 | |
| NCT03765671 | Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients | P1 | completed | 30 | Genfit | Dec 2018 | |
| NCT03124108 | PBC | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | P2 | completed | 45 | Genfit | Apr 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. 8 are marked completed.
- Are Elafibranor clinical trials recruiting in 2026?
- Yes — 2 Elafibranor trials are actively recruiting in 2026, with 33 U.S. sites across 15 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.
Last refreshed .
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