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Ezetimibe did not significantly reduce liver fat for NASH

In the MOZART trial, patients with nonalcoholic steatohepatitis treated with ezetimibe did not have significantly lower levels of liver fat vs. patients who received placebo.

“The MOZART trial breaks the boundaries of innovation in clinical trial design in the quest for noninvasive ways of assessing treatment response in nonalcoholic steatohepatitis,” researcher Rohit Loomba, MD, MHSc, of the division of gastroenterology and epidemiology, University of California, San Diego, told Healio.com/Hepatology.

Rohit Loomba

Loomba and colleagues randomly assigned 50 patients with NASH to 10 mg ezetimibe (Zetia, Merck) or placebo per day for 24 weeks. All patients underwent rigorous testing at baseline and posttreatment, including MRI-estimated proton density fat fraction (MRI-PDFF), to measure any changes in liver fat.

“This is the first trial to utilize magnetic resonance spectroscopy and MRI-PDFF for fat quantification along with 2-D and 3-D [magnetic resonance elastography] for assessment of fibrosis in a NASH trial,” Loomba said. “These data would inform the design and application of these novel imaging endpoints in clinical trials, as well as clinical practice in NASH and NAFLD, respectively.”

According to MRI-PDFF measurements, ezetimibe was not significantly better at reducing liver fat among the patients compared with placebo (mean difference of –1.3% between arms; P=.48). However, MRI-PDFF posttreatment measurements had a greater decrease from baseline measurements for the ezetimibe group (15% to 11.6%; P<.016) compared with the placebo group (18.5% to 16.4%; P=.15), indicating ezetimibe did, in fact, lower liver fat, but not by a substantial amount, according to the research.

There were no differences in 2-D magnetic resonance elastography or 3D magnetic resonance elastography-derived liver stiffness between either groups at baseline or posttreatment. Furthermore, there were no indicative decreases in aspartate aminotransferase, alanine aminotransferase or gamma-glutamyltransferase serum levels. Two patients from each group discontinued treatment; there were not differences in adverse events experienced by the two groups.     

“In this randomized, double blind, placebo-controlled MOZART trial, ezetimibe was not better than placebo in reducing liver fat or improving liver histology in NASH,” the researchers wrote. “Ezetimibe lowered liver fat by a small, but clinically unimportant amount. The trial, thus, provides compelling evidence that ezetimibe has no specific role in the treatment of NASH.” – by Melinda Stevens

Disclosure: The study was funded through a grant from Merck.