In NAFLD people, pemafibrate therapy for 72 weeks did not decrease the liver fat content. But, it considerably reduced magnetic resonance elastography-based liver stiffness.

This study was carried out to determine the safety and efficacy of pemafibrate (novel, selective peroxisome proliferator-activated receptor α modulator [SPPARMα]) in adults suffering from high-risk, non-alcoholic fatty liver disease (NAFLD).

Overall, 118 participants were randomized to either 0.2 mg pemafibrate (n=58) or placebo (n=60), orally, twice daily for seventy-two weeks. In this randomized, placebo-controlled, double-blind, multicentre, phase 2 clinical trial, the key inclusion criteria included liver fat content of ≥10% by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF); liver stiffness of ≥2.5 kPa, by magnetic resonance elastography; and elevated alanine aminotransferase (ALT) levels.

The percentage alteration in MRI-PDFF from baseline to week 24 was the major outcome ascertained while magnetic resonance elastography-based liver stiffness, ALT, serum liver fibrosis markers and lipid parameters were the secondary outcomes ascertained.

In terms of the primary outcome, no profound differences were noted between pemafibrate or placebo groups (treatment difference -1.0%), as shown in Table 1:

But, magnetic resonance elastography-based liver stiffness considerably dropped in comparison with placebo at week 48 (treatment difference -5.7%) and was maintained at week 72 (treatment difference -6.2%), with a considerable decline in ALT and low-density lipoprotein-cholesterol. Both the groups displayed comparable adverse events. The therapy was well-tolerated.

Pemafibrate appears to be a promising agent for NAFLD/non-alcoholic steatohepatitis, and also a candidate for combination therapy with agents that minimize fat content in the liver.