Elafibranor Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Elafibranor comprises 5 peer-reviewed publications across 4 journals, 3 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Liver Cirrhosis, Biliary, Cholangitis, Sclerosing, and Non-alcoholic Fatty Liver Disease. Most recent publication: Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE., Liver Int, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.
    Schattenberg JM, Pares A, Kowdley KV, et al. · J Hepatol · 2022
    PubMed: PMID 33484775 · NCT03124108 · Liver Cirrhosis, Biliary
  2. Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE.
    Levy C, Bowlus CL, Lawitz E, et al. · Liver Int · 2026
    PubMed: PMID 41937506 · NCT04526665 (ELATIVE) · Liver Cirrhosis, Biliary
  3. Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial.
    Levy C, Abouda GF, Bilir BM, et al. · J Hepatol · 2025
    PubMed: PMID 40350321 · NCT05627362 (ELMWOOD) · Cholangitis, Sclerosing
  4. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis.
    Kowdley KV, Bowlus CL, Levy C, et al. · N Engl J Med · 2024
    PubMed: PMID 37962077 · NCT04526665 (ELATIVE) · Liver Cirrhosis, Biliary
  5. An Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis.
    Goyal NP, Mencin A, Newton KP, et al. · J Pediatr Gastroenterol Nutr · 2023
    PubMed: PMID 37084342 · NCT03883607 · Non-alcoholic Fatty Liver Disease

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT02704403
RESOLVE-IT
Non-alcoholic Fatty Liver DiseaseNumber of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
Measurement at 72 weeks
120 mg Elafibranor138 Participants
Placebo52 Participants
NCT02704403
RESOLVE-IT
Non-alcoholic Fatty Liver DiseaseTime to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes
From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)
120 mg Elafibranor0 Participants
120 mg Elafibranor1 Participants
120 mg Elafibranor0 Participants
120 mg Elafibranor1437 Participants
120 mg Elafibranor1 Participants
120 mg Elafibranor48 Participants
120 mg Elafibranor1388 Participants
120 mg Elafibranor159 Participants
120 mg Elafibranor1277 Participants
120 mg Elafibranor53 Participants
120 mg Elafibranor374 Participants
120 mg Elafibranor1010 Participants
120 mg Elafibranor56 Participants
120 mg Elafibranor609 Participants
120 mg Elafibranor772 Participants
120 mg Elafibranor57 Participants
120 mg Elafibranor778 Participants
120 mg Elafibranor602 Participants
120 mg Elafibranor60 Participants
120 mg Elafibranor1049 Participants
120 mg Elafibranor328 Participants
120 mg Elafibranor61 Participants
120 mg Elafibranor1293 Participants
120 mg Elafibranor83 Participants
120 mg Elafibranor61 Participants
120 mg Elafibranor1374 Participants
120 mg Elafibranor2 Participants
120 mg Elafibranor61 Participants
120 mg Elafibranor1376 Participants
120 mg Elafibranor0 Participants
Placebo652 Participants
Placebo31 Participants
Placebo1 Participants
Placebo0 Participants
Placebo393 Participants
Placebo720 Participants
Placebo36 Participants
Placebo1 Participants
Placebo296 Participants
Placebo26 Participants
Placebo688 Participants
Placebo693 Participants
Placebo0 Participants
Placebo1 Participants
Placebo32 Participants
Placebo82 Participants
Placebo32 Participants
Placebo637 Participants
Placebo531 Participants
Placebo28 Participants
Placebo32 Participants
Placebo195 Participants
Placebo157 Participants
Placebo497 Participants
Placebo687 Participants
Placebo31 Participants
Placebo32 Participants
Placebo301 Participants
Placebo0 Participants
Placebo388 Participants
NCT04526665
ELATIVE
Liver Cirrhosis, BiliaryPercentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52
At Week 52
Elafibranor 80 mg50.9 Percentage of participants
Placebo3.8 Percentage of participants

Publications by year

2022–2026: 5 publications.

2022
1
2023
1
2024
1
2025
1
2026
1

Publications by indication

Liver Cirrhosis, Biliary (3)

  • Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE.
    Liver Int · 2026 · PMID 41937506 · NCT04526665
  • Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis.
    N Engl J Med · 2024 · PMID 37962077 · NCT04526665
  • A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.
    J Hepatol · 2022 · PMID 33484775 · NCT03124108

Cholangitis, Sclerosing (1)

  • Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial.
    J Hepatol · 2025 · PMID 40350321 · NCT05627362

Non-alcoholic Fatty Liver Disease (1)

  • An Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis.
    J Pediatr Gastroenterol Nutr · 2023 · PMID 37084342 · NCT03883607

Publications by journal

Trial-results highlights

In the RESOLVE-IT study (NCT02704403) for non-alcoholic fatty liver disease, results were reported at 72 weeks for the resolution of nonalcoholic steatohepatitis without worsening of fibrosis. This outcome was achieved by 138 participants in the 120 mg Elafibranor arm, compared to 52 participants in the placebo arm. For the time to a long-term outcome composed of all-cause mortality, cirrhosis, and liver-related clinical outcomes, measured up to 54 months, the 120 mg Elafibranor arm reported 0, 1, 0, 1437, 1, and 48 participants.

For liver cirrhosis of biliary origin, the ELATIVE study (NCT04526665) investigated the percentage of participants with a response to treatment based on cholestasis response at week 52. In this study, the 80 mg Elafibranor arm showed 50.9 percentage of participants with a response, while the placebo arm reported 3.8 percentage of participants with a response.

All values presented are sourced from primary registry reporting, and individual clinical papers should be consulted for clinical decisions.

All Elafibranor publications (5)

2026 (1 paper)

  1. Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE.
    Levy C, Bowlus CL, Lawitz E, et al. · Liver Int · 2026 · Derived
    PubMed: PMID 41937506 · NCT04526665 (ELATIVE) · Liver Cirrhosis, Biliary

2025 (1 paper)

  1. Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial.
    Levy C, Abouda GF, Bilir BM, et al. · J Hepatol · 2025 · Derived
    PubMed: PMID 40350321 · NCT05627362 (ELMWOOD) · Cholangitis, Sclerosing

2024 (1 paper)

  1. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis.
    Kowdley KV, Bowlus CL, Levy C, et al. · N Engl J Med · 2024 · Derived
    PubMed: PMID 37962077 · NCT04526665 (ELATIVE) · Liver Cirrhosis, Biliary

2023 (1 paper)

  1. An Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis.
    Goyal NP, Mencin A, Newton KP, et al. · J Pediatr Gastroenterol Nutr · 2023 · Derived
    PubMed: PMID 37084342 · NCT03883607 · Non-alcoholic Fatty Liver Disease

2022 (1 paper)

  1. A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.
    Schattenberg JM, Pares A, Kowdley KV, et al. · J Hepatol · 2022 · Derived
    PubMed: PMID 33484775 · NCT03124108 · Liver Cirrhosis, Biliary

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).