1 Harvard Medical School, 330 Brookline Ave, Boston, Massachusetts, United States.
A recent article by Sanyal and colleagues reported results of a randomized, double-blind, phase 2a study examining the effects of daily and weekly administration of pegbelfermin, a PEGylated fibroblast growth factor 21 (FGF21) analogue, compared to placebo among overweight and obese adults with biopsy-proven NASH and hepatic fat fraction ≥ 10% (Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, D Halegoua-DeMarzio, Sudeep Kundu D, Noviello S, Luo Y, Christian R. The Lancet 2018 Pegbelfermin (BMS-986036) a PEGylated fibroblast growth factor analogue, in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2a study. 392:2705-2717. The study treatment period was 16 weeks and the primary endpoints were absolute change in magnetic resonance imaging-proton density fat fraction (MRI-PDFF), safety, and efficacy. The major finding was an absolute reduction in liver fat with both doses of pegbelfermin (-5.8% and - 6.2%) compared to placebo, and overall the agent was well tolerated.