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Peer-reviewedCC BY 4.0Metabolites

Differential Modulation of Serum Albumin and Butyrylcholinesterase Following Pemafibrate Treatment in MASLD: A Post Hoc Analysis of the PEMA-FL Trial

  • Ryohei Tanigawa1,2
  • Rohit Loomba3
  • Yuichiro Eguchi4
  • Hirokazu Takahashi2
  • Hideki Suganami5
  • Andrey Belous6
  • Atsushi Nakajima7
7 affiliations
  1. 1Global Clinical Development Department, Kowa Company Ltd., 4-14, 3-Chome, Nihonbashi-Honcho Chuo-ku, Tokyo 103-8433, Japan
  2. 2Department of Hepatology, Division of Metabolism, Faculty of Medicine, Saga University, 1-1, 5-Chome, Nabeshima, Saga 849-8501, Japan
  3. 3MASLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, CA 92037, USA
  4. 4Loco Medical General Institute, 1-1178, Mikazukichokanada, Ogi 845-0032, Japan
  5. 5Clinical Data Science Department, Kowa Company Ltd., 4-14, 3-Chome, Nihonbashi-Honcho Chuo-ku, Tokyo 103-8433, Japan
  6. 6Clinical Development, Kowa Pharmaceutical Development, Inc., 500 Boylston Street, 17th Floor, Boston, MA 02116, USA
  7. 7Department of Gastroenterology, International University of Health and Welfare Atami Hospital, 13-1 Higashikaigancho, Atami 413-0012, Japan
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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.

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Cite

BibTeXRIS
BibTeX
@article{tanigawa2026differential,
  title = {{Differential Modulation of Serum Albumin and Butyrylcholinesterase Following Pemafibrate Treatment in MASLD: A Post Hoc Analysis of the PEMA-FL Trial}},
  author = {Ryohei Tanigawa and Rohit Loomba and Yuichiro Eguchi and Hirokazu Takahashi and Hideki Suganami and Andrey Belous and Atsushi Nakajima},
  journal = {Metabolites},
  year = {2026},
  month = oct,
  doi = {10.3390/metabo16100750},
  url = {https://www.mdpi.com/2218-1989/16/10/750},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Differential Modulation of Serum Albumin and Butyrylcholinesterase Following Pemafibrate Treatment in MASLD: A Post Hoc Analysis of the PEMA-FL Trial
AU  - Ryohei Tanigawa
AU  - Rohit Loomba
AU  - Yuichiro Eguchi
AU  - Hirokazu Takahashi
AU  - Hideki Suganami
AU  - Andrey Belous
AU  - Atsushi Nakajima
PY  - 2026
DA  - 2026/10/01
JO  - Metabolites
DO  - 10.3390/metabo16100750
UR  - https://www.mdpi.com/2218-1989/16/10/750
AB  - 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.
SN  - 2218-1989
ER  -