{
  "abstract": "Background: Pemafibrate, a selective peroxisome proliferator-activated receptor-α (PPARα) modulator, improves liver stiffness and biochemistry in metabolic dysfunction-associated steatotic liver disease (MASLD). The longitudinal responses of serum albumin and butyrylcholinesterase during pemafibrate treatment remain incompletely characterized. We performed an exploratory post hoc analysis to characterize the effects of pemafibrate on these biomarkers in patients with non-cirrhotic MASLD. Methods: In this exploratory post hoc analysis of the randomized PEMA-FL trial, 118 patients with non-cirrhotic MASLD received pemafibrate (0.4 mg/day) or placebo for 72 weeks. Longitudinal changes in serum albumin and butyrylcholinesterase were evaluated. Between-group differences were estimated using ANCOVA, with MMRM performed as a sensitivity analysis. Results: Serum albumin and butyrylcholinesterase remained largely unchanged in the placebo group. In contrast, treatment was associated with a sustained increase in serum albumin and a sustained decrease in serum butyrylcholinesterase from week 4 through week 72. At week 72, the adjusted between-group difference in serum albumin was 0.18 g/dL (95% confidence interval [CI], 0.11 to 0.24). The adjusted between-group difference in serum butyrylcholinesterase was −33.5 U/L (95% CI, −45.2 to −21.7). Findings from the MMRM sensitivity analysis were consistent with those of the primary ANCOVA analyses. Conclusions: In this exploratory post hoc analysis, pemafibrate treatment was associated with a sustained increase in serum albumin and a sustained decrease in butyrylcholinesterase activity in patients with non-cirrhotic MASLD. These biomarkers should be interpreted individually because the mechanisms and clinical significance of their differing responses remain uncertain. ClinicalTrials.gov: NCT03350165; registered on 20 November 2017.",
  "abstract_shown": true,
  "affiliations": [
    "Global Clinical Development Department, Kowa Company Ltd., 4-14, 3-Chome, Nihonbashi-Honcho Chuo-ku, Tokyo 103-8433, Japan",
    "Department of Hepatology, Division of Metabolism, Faculty of Medicine, Saga University, 1-1, 5-Chome, Nabeshima, Saga 849-8501, Japan",
    "MASLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, CA 92037, USA",
    "Loco Medical General Institute, 1-1178, Mikazukichokanada, Ogi 845-0032, Japan",
    "Clinical Data Science Department, Kowa Company Ltd., 4-14, 3-Chome, Nihonbashi-Honcho Chuo-ku, Tokyo 103-8433, Japan",
    "Clinical Development, Kowa Pharmaceutical Development, Inc., 500 Boylston Street, 17th Floor, Boston, MA 02116, USA",
    "Department of Gastroenterology, International University of Health and Welfare Atami Hospital, 13-1 Higashikaigancho, Atami 413-0012, Japan"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Ryohei Tanigawa",
      "orcid": "0009-0005-8804-2014"
    },
    {
      "affs": [
        2
      ],
      "name": "Rohit Loomba"
    },
    {
      "affs": [
        3
      ],
      "name": "Yuichiro Eguchi"
    },
    {
      "affs": [
        1
      ],
      "name": "Hirokazu Takahashi",
      "orcid": "0000-0003-1900-4389"
    },
    {
      "affs": [
        4
      ],
      "name": "Hideki Suganami"
    },
    {
      "affs": [
        5
      ],
      "name": "Andrey Belous",
      "orcid": "0009-0003-4273-0343"
    },
    {
      "affs": [
        6
      ],
      "name": "Atsushi Nakajima",
      "orcid": "0000-0002-6263-1436"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9fqczcpp12f8a.bib",
  "cited_by": 0,
  "doi": "10.3390/metabo16100750",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13706844/?tool=EBI",
  "id": "9fqczcpp12f8a",
  "issns": [
    "2218-1989"
  ],
  "landing_url": "https://www.mdpi.com/2218-1989/16/10/750",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2713|Liver Disease Diagnosis and Treatment"
    ]
  ],
  "openalex": "W7220747028",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13706844/pdf/?tool=EBI",
  "pmcid": "PMC13706844",
  "pmid": null,
  "published": "2026-10-01",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/9fqczcpp12f8a.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:00Z",
      "native_id": "10.3390/metabo16100750",
      "source": "crossref",
      "url": "https://www.mdpi.com/2218-1989/16/10/750"
    },
    {
      "first_seen": "2026-10-30T12:21:40Z",
      "native_id": "PMC:PMC13706844",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13706844"
    }
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2713|Liver Disease Diagnosis and Treatment",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Differential Modulation of Serum Albumin and Butyrylcholinesterase Following Pemafibrate Treatment in MASLD: A Post Hoc Analysis of the PEMA-FL Trial",
  "title_text": "Differential Modulation of Serum Albumin and Butyrylcholinesterase Following Pemafibrate Treatment in MASLD: A Post Hoc Analysis of the PEMA-FL Trial",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:40Z",
  "url": "https://research.draconitic.com/paper/9fqczcpp12f8a",
  "venue": "Metabolites",
  "versions": []
}