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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).
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.
Alimentary Pharmacology & Therapeutics
Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα), versus placebo in patients with non-alcoholic fatty liver disease
Atsushi Nakajima et al.
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