ALT Reduction Following Pemafibrate Treatment in MASLD and MetALD with Dyslipidemia: Associations with the Baseline Liver Enzyme Levels

Q: What are the key findings of this study?

Pemafibrate treatment for 24 weeks significantly reduced median ALT levels by 24.75% (from 29 U/L to 22 U/L) in patients with MASLD or MetALD and dyslipidemia.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: MASLD and MetALD with dyslipidemia (n=110). Intervention: Pemafibrate vs. Baseline (before treatment). Primary outcome: Change in alanine aminotransferase (ALT) from baseline to 24 weeks (-24.75% median reduction, p=<0.001).

Q: What does this research mean for the field?

Pemafibrate treatment for 24 weeks significantly improves lipid profiles and reduces ALT levels by a median of 24.75% in patients with MASLD or MetALD and dyslipidemia. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate biochemical changes and factors associated with alanine aminotransferase (ALT) reduction after 24 weeks of pemafibrate treatment in patients with dyslipidemia and either MASLD or MetALD.

Takako Nomura; Masafumi Ono; Kiyoyuki Kobayashi; Maiko Murakami; Yudai Sato; Maki Ayaki; Tomohiro Ogi; Kayo Ishikawa; Asahiro Morishita; Hideki Kobara

doi:10.2169/internalmedicine.7791-26

January 1, 2026Internal MedicineOpen Access

ALT Reduction Following Pemafibrate Treatment in MASLD and MetALD with Dyslipidemia: Associations with the Baseline Liver Enzyme Levels

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Key result

Pemafibrate linked to ~25% reduction in median ALT levels in MASLD and MetALD.

-24.75% median reduction
P<0.001
n=110

Why the study?

Data on the effects of pemafibrate treatment in metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD) with dyslipidemia remain limited.

Does pemafibrate reduce ALT levels and improve lipid profiles in patients with MASLD or MetALD with dyslipidemia?

Key Points

To evaluate biochemical changes and factors associated with alanine aminotransferase (ALT) reduction after 24 weeks of pemafibrate treatment in patients with dyslipidemia and either MASLD or MetALD.
Retrospective, single-center cohort study evaluating 110 patients (96 with MASLD and 14 with MetALD) treated with pemafibrate for 24 weeks.
Assessed changes in liver function tests, lipid profiles, and body mass index, using correlation and multivariable regression analyses to identify predictors of ALT response.
Across all 110 patients, median ALT decreased from 29 to 22 U/L (p <0.001) with an overall median reduction rate of −24.75%, while triglycerides fell from 262 to 138 mg/dL (p <0.001) and HDL cholesterol increased from 44 to 51 mg/dL (p <0.001).
ALT reduction was greater in the MetALD subgroup than in the MASLD subgroup for absolute change (−17.5 vs. −7.0 U/L, p = 0.008) and reduction rate (−47.0% vs. −23.1%, p = 0.015; group × time interaction coefficient −15.573, 95% CI −26.747 to −4.399, p = 0.006).
Baseline ALT (r = −0.468, p <0.001), AST (r = −0.442, p <0.001), and GGT (r = −0.480, p <0.001) correlated with the ALT reduction rate, but none remained significant independent predictors in multivariable modeling.

Study Design

Type

Cohort (n=110)

Multicenter

No

Structured PICO

Does pemafibrate reduce ALT levels and improve lipid profiles in patients with MASLD or MetALD with dyslipidemia?

P

Population

110 adult patients (median age 63, 30.9% female) with MASLD or MetALD complicated by dyslipidemia, treated with pemafibrate and evaluated over a 24-week period.

E

Exposure

Pemafibrate 0.1 mg oral twice daily for 24 weeks.

O

Outcome

Change in ALT from baseline to 24 weeks (calculated as (ALT 24 weeks – ALT baseline) / ALT baseline × 100%).surrogate

Main Result

Effect estimate: -24.75% median reduction

Absolute Event Rate: 22% vs 29%

p-value: p=<0.001

Pemafibrate significantly improves surrogate markers of liver injury and dyslipidemia over 24 weeks in patients with metabolic dysfunction-associated steatotic liver disease.

Limitations

Retrospective, single-center study without a control group
Small MetALD subgroup (n=14) limiting statistical power for subgroup comparisons
Initial responder definition (any ALT decrease) may include changes of limited clinical relevance
Assessed only biochemical markers without imaging, histological evaluation, or long-term outcome data
Small MetALD subgroup (n=14), limiting statistical power

Implication

Pemafibrate was associated with ALT reduction in MASLD/MetALD; hypothesis-generating and requires randomized confirmation before practice change.

Abstract

Objective Pemafibrate improves the liver function and lipid profiles in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). However, the data on metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD) remain limited. This study evaluated the biochemical changes after pemafibrate treatment in both conditions with dyslipidemia, focusing on alanine aminotransferase (ALT) reduction and the factors associated with the treatment response. Methods This retrospective, single-center cohort study analyzed changes in liver function tests, lipid profiles, and body mass index after 24 weeks of pemafibrate treatment. The factors associated with ALT reduction were assessed using correlation and multivariate regression analyses. Patients were classified as ALT responders or non-responders based on ALT changes at 24 weeks. Patients Ninety-six patients with MASLD and 14 with MetALD were included in the study. Results After 24 weeks, the liver function tests and lipid profiles improved significantly in patients with MASLD, and similar changes were observed in the MetALD subgroup. The median ALT reduction rate was -24.75%. Baseline ALT, AST, and GGT levels correlated with the ALT reduction rate, but none remained significant in the multivariable model using continuous liver enzyme variables. ALT reduction was greater in the MetALD subgroup, although this finding requires further exploration. Conclusion Pemafibrate treatment was associated with an improved liver function and lipid profiles in patients with MASLD complicated by dyslipidemia. The findings in the small MetALD subgroup were exploratory. Baseline ALT, AST, and GGT levels were correlated with ALT reduction, but none were independent predictors in the multivariable model.

Discussion

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Cite This Study

Nomura et al. (2026) conducted a cohort in MASLD and MetALD with dyslipidemia (n=110). Pemafibrate vs. Baseline (before treatment) was evaluated on Change in alanine aminotransferase (ALT) from baseline to 24 weeks (-24.75% median reduction, p=<0.001). Pemafibrate treatment for 24 weeks significantly reduced median ALT levels by 24.75% (from 29 U/L to 22 U/L) in patients with MASLD or MetALD and dyslipidemia.

synapsesocial.com/papers/6ad0fc263afa093ea9acfc6f https://doi.org/10.2169/internalmedicine.7791-26

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ALT Reduction Following Pemafibrate Treatment in MASLD and MetALD with Dyslipidemia: Associations with the Baseline Liver Enzyme Levels

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

ALT Reduction Following Pemafibrate Treatment in MASLD and MetALD with Dyslipidemia: Associations with the Baseline Liver Enzyme Levels

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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